VIKTORIA-2: A Randomized, Open-Label, Phase 3 Study of Fulvestrant and CDK4/6 Inhibitors With or Without Gedatolisib as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast Cancer

This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant and CDK4/6 Inhibitors for the treatment of patients with locally advanced or metastatic HR+/HER2- advanced breast cancer.

Start Date30 Jun 2025

Sponsor / Collaborator

Celcuity, Inc.

NCT06753747

/ Not yet recruitingPhase 1/2IIT

A Phase 1b/2 Trial of Afatinib Plus Palbociclib in Previously Treated Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

The goal of this clinical trial is to learn if Afatinib plus Palbociclib works in previously treated recurrent or metastatic esophageal squamous cell carcinoma. It will also learn about the safety of the combination of Afatinib and Palbociclib. The main questions it aims to answer are:
What is the safe and tolerable dose of Afatinib when combined with 100 mg of Palbociclib (administered orally, three weeks on and one week off)?
Does the combination therapy of Afatinib and Palbociclib induce a tumor response in patients with recurrent or metastatic esophageal squamous cell carcinoma who have received prior treatments?

Start Date01 Apr 2025

Sponsor / Collaborator

West China Hospital

NCT06810492

/ Not yet recruitingNot ApplicableIIT

A Single-arm Exploratory Study of the Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment of HR+/HER2- Early Breast Cancer

To explore the efficacy and safety of CDK4/6 inhibitors combined with endocrine neoadjuvant therapy for stage II-III HR-positive/HER2-negative breast cancer.
This study adopts a single-arm, open-label design, and plans to include 40 patients with stage II-III HR+/HER2- breast cancer.

Start Date01 Feb 2025

Sponsor / Collaborator

Hubei Cancer Hospital

100 Clinical Results associated with Palbociclib

100 Translational Medicine associated with Palbociclib

100 Patents (Medical) associated with Palbociclib

3,395

Literatures (Medical) associated with Palbociclib

01 Apr 2025·INTERNATIONAL JOURNAL OF CANCER

Cyclin‐dependent kinase 4/6 inhibitors and cardiotoxic events in breast cancer: A pharmacovigilance study based on the FAERS database

Article

Author: Cao, Weihang ; Jin, Pengfei ; Li, Ting ; Zhao, Ming ; Li, Shaoqiang ; Kou, Chen ; Huang, Jing ; Zhang, Tian ; Zhang, Miaomiao

Abstract:

Recent trials have highlighted the cardiotoxicity of ribociclib, a CDK4/6 inhibitor, particularly its association with QT prolongation. However, studies on the link between CDK4/6 inhibitors and cardiotoxic events show inconsistent results, and the factors influencing these events and related drug interactions remain underexplored. To address these uncertainties, our study utilizes the FDA adverse event reporting system database (Q1 2015 to Q1 2024) to examine the cardiotoxic events of CDK4/6 inhibitors in breast cancer patients. We employed a comprehensive analytical framework, applying disproportionality methods including Bayesian confidence propagation neural network, proportional reporting ratio, and reporting odds ratio. Our findings highlight significant variability in cardiotoxic events among different CDK4/6 inhibitors, with ribociclib (IC: 0.26, 95%CI: 0.18–0.34) exhibiting pronounced cardiotoxicity. Notably, ribociclib was associated with serious cardiotoxic events such as torsade de pointes/QT prolongation (IC: 2.11, 95% CI: 1.90–2.29) and conduction defects (IC: 2.07, 95% CI: 1.87–2.23). For the first time, palbociclib has been identified with positive signals for cardiotoxic events at the preferred terms level, including pulmonary oedema, increased blood pressure, myocardial infarction, and cardiac flutter. Moreover, multivariable logistic regression and Bayesian network analyses reveal that age, geographic location, and the number of concomitant medications significantly influence cardiotoxic events. Our study also highlights significant drug interactions that increase the probability of specific cardiotoxic outcomes, notably with drugs like sertraline, lansoprazole, capecitabine, and torasemide. These findings highlight the need for personalized treatment plans to mitigate cardiotoxic events and improve patient safety.

01 Apr 2025·CURRENT PHARMACEUTICAL DESIGN

Exploration of Novel Therapeutic Targets for Breast Carcinoma and Molecular Docking Studies of Anticancer Compound Libraries with Cyclin-dependent Kinase 4/6 (CDK4/6): A Comprehensive Study of Signalling Pathways for Drug Repurposing

Article

Author: Najmi, Asim

Aims::

This study aims to identify and evaluate promising therapeutic proteins and compounds for breast cancer treatment through a comprehensive database search and molecular docking analysis.

Background::

Breast cancer (BC), primarily originating from the terminal ductal-lobular unit of the breast, is the most prevalent form of cancer globally. In 2020, an estimated 2.3 million new cases were reported, resulting in approximately 685,000 deaths. Mutations in the BRCA1 and BRCA2 genes are well-established in hereditary breast cancer. The identification of effective therapeutic proteins for BC remains a complex and evolving area of research.

Objective::

This study aims to identify and evaluate promising therapeutic proteins and compounds specific to breast cancer through a comprehensive database search and molecular docking analysis.

Methods::

A rigorous search was conducted within the National Cancer Institute (NCI), NCI Metathesaurus, SIGnaling Network Open Resource (SIGNOR), Human Protein Atlas (HPA), and the Human Phenotype Ontology (HPO) to shortlist proteins linked to BC (CUI C0678222). Recent studies were reviewed to understand the administration of CDK4/6 inhibitors (palbociclib, ribociclib, abemaciclib) combined with endocrine therapy for HR-positive and HER2-negative breast cancer. Anticancer compound libraries available at ZINC and PubChem were analyzed. Compounds were evaluated based on their binding energies with CDK4 protein, a rationally selected druggable target.

Results::

Key proteins linked to breast cancer were identified through database searches. Proliferation, apoptosis, and G1/S transition pathways were frequently found dysregulated in breast cancer. ZINC13152284 exhibited the strongest binding energy at -10.9 Kcal/mol, followed by ZINC05492794 with a binding energy of -10.4 Kcal/mol. Preexisting drugs showed lower binding energies with the CDK4 protein.

Conclusion::

The study highlights the importance of drug repurposing as a strategy for the safe and effective treatment of breast cancer. Synthetic inhibitors often cause severe side effects, emphasizing the need for novel targets and compounds with better therapeutic profiles. Molecular docking identified promising compounds from the ZINC database, suggesting potential new avenues for breast cancer therapy.

01 Mar 2025·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Three sample preparation methods for clinical determination of CDK4/6 inhibitors with endocrine therapy in breast cancer patient plasma using LC-MS: Cross-validation (red), ecological (green) and economical (blue) assessment

Article

Author: Mlinarić, Zvonimir ; Turković, Lu ; Sertić, Miranda ; Lovrić, Mila ; Silovski, Tajana ; Nigović, Biljana

Cyclin D-dependent kinase 4/6 inhibitors palbociclib, ribociclib and abemaciclib, in combination with aromatase inhibitors anastrozole and letrozole or oestrogen receptor degrader fulvestrant, are being assessed as candidates for therapeutic drug monitoring. An ideal bioanalytical method for their determination in patient plasma samples is therefore of high interest, as there is no routine reference method yet available in the clinical practice. In this work, three sample preparation approaches - dispersive liquid-liquid microextraction (DLLME), solid-phase extraction (SPE), and newly developed phospholipid removal (PLR) for LC-MS determination of these six drugs are comprehensively assessed. The methods are validated in the clinically relevant linear ranges with remarkable precision (RSD ≤6.9 %) and accuracy (bias -13.6 - 11.8 %). To compare the procedures in a real-world setting, they are applied on 38 samples from breast cancer patients. The differences between paired results are below 20 % for more than 92 % of the repeats and the RSD is ≤13.1 % between the corresponding results. Statistical comparison of the results reveals excellent overall agreement between the methods (Lin's concordance correlation coefficient ≥0.9969, maximal Bland-Altman bias 6.3 %). DLLME proved to be the most ecologically acceptable method due to the high degree of miniaturisation (AGREEprep score 0.44), PLR enabled very high sample throughput and cost-effectiveness (BAGI 72.5), while SPE showed the best analytical performance (redness score 100). All three methods are suitable for their designated purpose, and the choice of the ideal method can be made based on the scope of application, available funds and equipment and desired ecological footprint.

347

News (Medical) associated with Palbociclib

11 Feb 2025

·www.globenewswire.com

Arvinas Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update

– Announced that topline data from the monotherapy Phase 3 VERITAC-2 trial is anticipated in 1Q25 – – Presented Phase 1b data from the TACTIVE-U sub-study of vepdegestrant in combination with abemaciclib that demonstrated encouraging clinical activity (clinical benefit rate: 62.5%; overall response rate: 26.7%) in patients previously treated with a CDK4/6 inhibitor – – Announced the planned initiation of first-line Phase 3 trial evaluating vepdegestrant in combination with Pfizer’s novel investigational CDK4 inhibitor atirmociclib and a second-line Phase 3 combination trial evaluating vepdegestrant with a CDK4/6 inhibitor, both planned to begin in 2025 – – Initiated a Phase 1 trial with ARV-102 in patients with Parkinson’s disease and announced Phase 1 data in healthy volunteers has been accepted for oral presentation at Alzheimer’s Disease/Parkinson’s Disease congress – – Company to host conference call today at 8:00 a.m. ET – NEW HAVEN, Conn., Feb. 11, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today reported financial results for the fourth quarter and full year ended December 31, 2024, and provided a corporate update. "We made significant progress across our pipeline in 2024, all of which we believe supports our mission to improve the lives of patients with debilitating and life-threatening diseases," said John Houston, Ph.D., Chairperson, Chief Executive Officer and President at Arvinas. "Looking ahead, we are on the cusp of a number of firsts, including results from VERITAC-2, the first ever Phase 3 clinical trial of a PROTAC. In addition, we plan to present the first-in-human data for our most advanced neuroscience program, ARV-102, which we believe will highlight the potential value our PROTAC degraders can offer to patients with neurodegenerative diseases. In the coming months, we look forward to sharing additional updates emerging from our pipeline and PROTAC platform.” 4Q 2024 Business Highlights and Recent Developments Vepdegestrant: Oral PROTAC ER degrader Announced that the VERITAC-2 Phase 3 monotherapy clinical trial evaluating vepdegestrant in ER+/HER2- metastatic breast cancer remains on track, with topline data anticipated in 1Q25 (ClinicalTrials.gov Identifier: NCT05654623).Announced plans to initiate two new Phase 3 combination trials in patients with ER+/HER2- mBC (pending emerging data and regulatory feedback) in 2025: First-line Phase 3 combination trial with Pfizer’s novel investigational CDK4 inhibitor, atirmociclib.Second-line Phase 3 combination trial with a CDK4/6 inhibitor. Presented initial Phase 1b safety and pharmacokinetic data from the TACTIVE-U sub-study of vepdegestrant in combination with abemaciclib at the San Antonio Breast Cancer Symposium (SABCS) in December 2024 (ClinicalTrials.gov Identifier: NCT05548127).Presented data from the Phase 1 clinical pharmacology study of vepdegestrant in combination with midazolam at SABCS in December 2024 (ClinicalTrials.gov Identifier: NCT06256510).Continued enrollment globally in multiple additional clinical studies of vepdegestrant in ER+/HER2- metastatic breast cancer. TACTIVE-K: Phase 1b/2 clinical trial with vepdegestrant in combination with Pfizer’s novel investigational CDK4 inhibitor atirmociclib (ClinicalTrials.gov Identifier: NCT06206837).TACTIVE-U: Phase 1b/2 combination umbrella trial evaluating combinations of vepdegestrant with abemaciclib, ribociclib, or samuraciclib (ClinicalTrials.gov Identifiers: NCT05573555, and NCT06125522). ARV-393: Oral PROTAC BCL6 degrader Continued recruiting patients in the first-in-human Phase 1 clinical trial in patients with non-Hodgkin lymphoma (NHL) (ClinicalTrials.gov Identifier: NCT06393738). ARV-102: Oral PROTAC LRRK2 degrader Completed enrollment in the multiple ascending (MAD) dose cohort of the Phase 1 clinical trial in healthy volunteers in 1Q25.Initiated dosing of the first patients with Parkinson’s disease (PD) in the single ascending dose (SAD) cohort of a Phase 1 clinical trial. Corporate Completed the Investigational New Drug application (IND) transition of luxdegalutamide (ARV-766) to Novartis as part of global license agreement executed in April 2024.Announced Alex Santini, Arvinas’ Senior Vice President, Global and U.S. Market Access, has been appointed interim Chief Commercial Officer effective January 17, 2025. Anticipated Upcoming Milestones and Expectations Vepdegestrant: Oral PROTAC ER degraderAs part of Arvinas global collaboration with Pfizer, the companies plan to: Announce topline data for the VERITAC-2 Phase 3 monotherapy clinical trial evaluating vepdegestrant in patients with ER+/HER2- metastatic breast cancer (mBC) in a topline press release 1Q25 and present full results of the trial at a medical conference in 2025.Initiate two new Phase 3 combination trials in patients with ER+/HER2- mBC (pending emerging data and regulatory feedback) in 2025: First-line Phase 3 combination trial with Pfizer’s novel investigational CDK4 inhibitor, atirmociclib.Second-line Phase 3 combination trial with a CDK4/6 inhibitor.With the prioritization of the vepdegestrant plus atirmociclib combination for the first-line setting, the VERITAC-3 Phase 3 clinical trial evaluating vepdegestrant plus palbociclib in the first-line will not proceed beyond the study lead-in. Continue to collect safety and efficacy data from ongoing TACTIVE-U sub-studies evaluating combination of vepdegestrant with abemaciclib, ribociclib, or samuraciclib (ClinicalTrials.gov Identifiers: NCT05548127, NCT05573555, and NCT06125522) and submit key data for presentation at medical conference.Continue enrollment in the Phase 2 TACTIVE-K clinical trial (atirmociclib + vepdegestrant) and submit initial Phase 1b data for presentation at a medical conference. ARV-393: Oral PROTAC BCL6 degrader Present preclinical data of ARV-393 in combination with standard of care biologic agents and small molecule inhibitors in high grade and aggressive diffuse large B-cell lymphoma in vivo models at the American Association for Cancer Research Annual Meeting (April 25-30, 2025).Disclose preliminary data from the ongoing Phase 1 clinical trial in patients with NHL (ClinicalTrials.gov Identifier: NCT06393738) in 2025. ARV-102: Oral PROTAC LRRK2 degrader Present SAD data from the ongoing Phase 1 clinical trial in healthy volunteers in an oral session at the Alzheimer’s Disease/Parkinson’s Disease (AD/PD) conference in Vienna, Austria (April 1-4, 2025) demonstrating: Bioavailability and brain penetration with dose dependent exposure in cerebral spinal fluid (CSF)Degradation of LRRK2 in the periphery and CSF of healthy volunteers Complete enrollment and present initial data from the ongoing SAD Phase 1 clinical trial in patients with PD in 2025; initiate MAD cohort in patients with PD in 2025. Novel PROTAC KRAS G12D degrader File an Investigational New Drug (IND) application in 2025. Financial GuidanceBased on its current operating plan, Arvinas believes its cash, cash equivalents, and marketable securities as of December 31, 2024, is sufficient to fund planned operating expenses and capital expenditure requirements into 2027. Full Year and Fourth Quarter Financial Results Cash, Cash Equivalents, and Marketable Securities Position: As of December 31, 2024, cash, cash equivalents and marketable securities were $1,039.4 million as compared with cash, cash equivalents, restricted cash and marketable securities of $1,266.5 million as of December 31, 2023. The decrease in cash, cash equivalents and marketable securities of $227.1 million for the 12 months ended December 31, 2024 was primarily related to cash used in operations of $237.4 million (net of $150.0 million received from the Novartis agreements), inclusive of a one-time cash termination fee in the amount of $41.5 million related to the termination of our laboratory and office space lease with 101 College Street LLC in August 2024, the purchase of lab equipment and leasehold improvements of $1.8 million and $0.4 million of long term debt repayments, partially offset by proceeds from the exercise of stock options of $8.3 million, unrealized gains on marketable securities of $4.1 million and proceeds from disposal of equipment of $0.1 million. Research and Development Expenses: Research and development expenses were $348.2 million and $83.3 million for the year and quarter ended December 31, 2024, respectively, as compared with $379.7 million and $95.2 million for the year and quarter ended December 31, 2023, respectively. The decrease in research and development expenses of $31.5 million for the year was primarily due to a decrease in external expenses of $41.7 million, partially offset by an increase in compensation and related personnel expenses of $11.2 million, which are not allocated by program. External expenses include program-specific expenses, which decreased by $32.1 million, driven by decreases in our vepdegestrant and bavdegalutamide (ARV-110) programs of $27.9 million and $18.1 million, respectively, partially offset by increases in our ARV-102 and ARV-393 programs of $10.7 million and $5.4 million, respectively, and our non-program specific expenses, which decreased by $9.6 million. The decrease in research and development expenses of $11.9 million for the quarter was primarily due to a decrease in external expenses of $9.9 million, compensation and related personnel expenses of $0.5 million, which are not allocated by program, and other expenses of $1.5 million. External expenses include program-specific expenses, which decreased by $14.2 million, primarily driven by decreases in our vepdegestrant, luxdegalutamide (ARV-766) and bavdegalutamide (ARV-110) programs of $13.6 million, $6.0 million and $2.6 million, respectively, partially offset by increases in our ARV-102 and ARV-393 programs of $5.5 million and $1.3 million, respectively, and our non-program specific expenses of $4.3 million. General and Administrative Expenses: General and administrative expenses were $165.4 million and $34.1 million for the year and quarter ended of December 31, 2024, respectively, as compared with $100.3 million and $27.0 million for the year and quarter ended of December 31, 2023, respectively. The increase in general and administrative expenses of $65.1 million for the year was primarily due to a loss on the termination of our laboratory and office space lease with 101 College Street LLC in August 2024 of $43.4 million as well as increases in personnel and infrastructure related costs of $9.0 million, professional fees of $8.1 million and in developing our commercial operations of $4.2 million. The increase in general and administrative expenses of $7.1 million for the quarter was primarily due to increases in developing our commercial operations of $2.6 million, personnel and infrastructure related costs of $2.2 million and professional fees of $1.8 million. Revenue: Revenue was $263.4 million and $59.2 million for the year and quarter ended December 31, 2024, respectively, as compared with $78.5 million and $(43.1) million for the year and quarter ended December 31, 2023, respectively. The increase in revenue of $184.9 million for the year was primarily due to revenue from the Novartis agreements of $162.4 million, an increase in revenue from the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer of $21.7 million related in part to adjustments to revenue in 2023 from changes in contract estimates and year over year increases in revenue of $2.8 million and $2.2 million from the Bayer Collaboration Agreement and the Pfizer Research Collaboration Agreement, respectively, primarily due to changes in estimates in 2023 of the performance period duration under the agreements resulting from updated research timelines, offset by a decrease of $2.5 million of previously constrained deferred revenue related to our Oerth Bio joint venture, and a decrease of $1.8 million of revenue under the Restated Genentech Agreement as the performance period had concluded in 2023. The increase in revenue of $102.3 million for the quarter was primarily related to an increase in revenue from the Pfizer ARV-471 Collaboration Agreement totaling $63.8 million, primarily due to adjustments in 2023 to revenue from changes in contract estimates, as well as revenue from the Novartis agreements of $40.3 million, offset by a decrease in revenue from Bayer of $1.6 million related to the termination of the Bayer Collaboration Agreement in August 2024. Investor Call & Webcast Details Arvinas will host a conference call and webcast today, February 11, 2025, at 8:00 a.m. ET to review its fourth quarter and full year 2024 financial results and discuss recent corporate updates. Participants are invited to listen by going to the Events and Presentation section under the Investors page on the Arvinas website at www.arvinas.com. A replay of the webcast will be available on the Arvinas website following the completion of the event and will be archived for up to 30 days. About VepdegestrantVepdegestrant is an investigational, orally bioavailable PROTAC protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with ER positive (ER+)/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer. Vepdegestrant is being developed as a potential monotherapy and as part of combination therapy across multiple treatment settings for ER+/HER2- metastatic breast cancer. In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will share worldwide development costs, commercialization expenses, and profits. The U.S. Food and Drug Administration (FDA) has granted vepdegestrant Fast Track designation as a monotherapy in the treatment of adults with ER+/HER2- locally advanced or metastatic breast cancer previously treated with endocrine-based therapy. About ArvinasArvinas (Nasdaq: ARVN) is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases. Through its PROTAC (PROteolysis Targeting Chimera) protein degrader platform, Arvinas is pioneering the development of protein degradation therapies designed to harness the body’s natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. Arvinas is currently progressing multiple investigational drugs through clinical development programs, including vepdegestrant, targeting the estrogen receptor for patients with locally advanced or metastatic ER+/HER2- breast cancer; ARV-393, targeting BCL6 for relapsed/refractory non-Hodgkin Lymphoma; and ARV-102, targeting LRRK2 for neurodegenerative disorders. Arvinas is headquartered in New Haven, Connecticut. For more information about Arvinas, visit www.arvinas.com and connect on LinkedIn and X. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding: the progress made across Arvinas’ pipeline in 2024 supporting Arvinas’ mission to improve the lives of patients with debilitating and life-threatening diseases; the expected timing in connection with the reporting of topline data from the VERITAC-2 Phase 3 clinical trial and presentation of full results at a medical congress; the plans to present the first-in-human data for ARV-102 and the presentation of such data highlighting the potential value Arvinas’ PROTAC degraders can offer to patients with neurodegenerative diseases; the plans related to the initiation of two Phase 3 vepdegestrant combination trials, in the first- and second-line settings, and the timing thereof; plans to continue to collect safety and efficacy data from ongoing TACTIVE-U sub-studies and submit key data from TACTIVE-U for presentation at a medical conference; plans to continue enrollment in the Phase 2 TACTIVE-K clinical trial and submit initial Phase 1b data from TACTIVE-K for presentation at a medical conference; plans to present preclinical data of ARV-393 in combination with standard of care biologic agents and small molecule inhibitors in high grade and aggressive DLBCL in vivo models; plans to present single ascending dose (“SAD”) data from the ongoing Phase 1 clinical trial of ARV-102 in healthy volunteers; plans to complete enrollment and present initial data from the ongoing SAD Phase 1 clinical trial of ARV-102 in patients with Parkinson’s disease (“PD”) and initiate a multiple ascending dose cohort in patients with PD; plans to file an Investigational New Drug application for a novel KRAS G12D PROTAC degrader and the timing thereof; vepdegestrant’s development as a potential monotherapy and as part of combination therapy across multiple treatment settings for estrogen receptor positive, human epidermal growth factor receptor 2 negative metastatic breast cancer; and statements regarding Arvinas’ cash, cash equivalents and marketable securities, including their sufficiency to fund planned operating expenses and capital expenditure requirements into 2027. All statements, other than statements of historical fact, contained in this press release, including statements regarding Arvinas’ strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “predict,” “project,” “target,” “goal,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Arvinas may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on such forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements Arvinas makes as a result of various risks and uncertainties, including but not limited to: whether Arvinas and Pfizer will successfully perform their respective obligations under the collaboration between Arvinas and Pfizer; whether Arvinas and Pfizer will be able to successfully conduct and complete clinical development for vepdegestrant; whether Arvinas will be able to successfully conduct and complete development for its other product candidates, including ARV-393 and ARV-102, and including whether Arvinas initiates and completes clinical trials for its product candidates and receives results from its clinical trials and preclinical studies on its expected timelines or at all; whether Arvinas and Pfizer, as appropriate, will be able to obtain marketing approval for and commercialize vepdegestrant and other product candidates on current timelines or at all; Arvinas’ ability to protect its intellectual property portfolio; Arvinas’ reliance on third parties; whether Arvinas will be able to raise capital when needed; whether Arvinas’ cash and cash equivalent resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; and other important factors discussed in the “Risk Factors” section of Arvinas’ Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent other reports on file with the U.S. Securities and Exchange Commission. The forward-looking statements contained in this press release reflect Arvinas’ current views with respect to future events, and Arvinas assumes no obligation to update any forward-looking statements, except as required by applicable law. These forward-looking statements should not be relied upon as representing Arvinas’ views as of any date subsequent to the date of this release. ContactsInvestors:Jeff Boyle+1 (347) 247-5089Jeff.Boyle@arvinas.com Media:Kirsten Owens+1 (203) 584-0307Kirsten.Owens@arvinas.com ARVINAS, INC. AND SUBSIDIARIES Consolidated Balance Sheets (Unaudited) December 31, (dollars and shares in millions, except per share amounts) 2024 2023 Assets Current assets: Cash and cash equivalents$100.5 $311.7 Restricted cash — 5.5 Marketable securities 938.9 949.3 Accounts receivable 5.7 — Other receivables 8.0 7.2 Prepaid expenses and other current assets 14.2 6.5 Total current assets 1,067.3 1,280.2 Property, equipment and leasehold improvements, net 7.0 11.5 Operating lease right of use assets 9.0 2.5 Collaboration contract asset and other assets 8.1 10.4 Total assets$1,091.4 $1,304.6 Liabilities and stockholders' equity Current liabilities: Accounts payable and accrued liabilities$71.8 $92.2 Deferred revenue 156.2 163.0 Current portion of operating lease liability 1.8 1.9 Total current liabilities 229.8 257.1 Deferred revenue 292.0 386.2 Long term debt 0.6 0.8 Operating lease liability 7.3 0.5 Total liabilities 529.7 644.6 Stockholders' equity: Preferred stock, $0.001 par value, zero shares issued and outstanding as of December 31, 2024 and 2023, respectively — — Common stock, $0.001 par value, 68.8 and 68.0 shares issued and outstanding as of December 31, 2024 and 2023, respectively 0.1 0.1 Accumulated deficit (1,531.6) (1,332.7) Additional paid-in capital 2,092.2 1,995.7 Accumulated other comprehensive income (loss) 1.0 (3.1) Total stockholders' equity 561.7 660.0 Total liabilities and stockholders' equity$1,091.4 $1,304.6 ARVINAS, INC. AND SUBSIDIARIESConsolidated Statements of Operations (Unaudited) Three Months Ended December 31,Year Ended December 31,(dollars and shares in millions, except per share amounts) 2024 2023 2024 2023 Revenue$59.2 $(43.1)$263.4 $78.5 Operating expenses: Research and development 83.3 95.2 348.2 379.7 General and administrative 34.1 27.0 165.4 100.3 Total operating expenses 117.4 122.2 513.6 480.0 Loss from operations (58.2) (165.2) (250.2) (401.5)Interest and other income 12.7 12.1 51.9 37.6 Net loss before income taxes and loss from equity method investment (45.5) (153.2) (198.3) (363.9)Income tax benefit (expense) 0.4 (1.6) (0.6) (0.9)Loss from equity method investment — — — (2.5)Net loss$(45.1)$(154.8)$(198.9)$(367.3)Net loss per common share - basic and diluted$(0.63)$(2.53)$(2.77)$(6.62)Weighted average common shares outstanding - basic and diluted 72.1 61.1 71.9 55.5

Phase 1Financial StatementPhase 3Executive ChangeFast Track

06 Feb 2025

·www.echemi.com

Pfizer Reports 2024 Earnings with $63.6 Billion Revenue and Concerns Over Innovation

On February 4, Pfizer announced its financial results for the fourth quarter and the entire year of 2024, revealing a total revenue of $63.6 billion, a 7% increase year-on-year. The fourth quarter alone saw revenues of $17.8 billion, reflecting a substantial 22% growth compared to the same period last year. However, the net profit for the year was $8.031 billion, with only $410 million generated in the fourth quarter, raising concerns among investors. Pfizer operates through three main business segments: Generic Medicines, Specialty Medicines, and Oncology. The Generic Medicines division reported annual revenues of $30.135 billion, a 2% decline from the previous year. In contrast, the Specialty Medicines segment achieved $16.652 billion in revenue, marking an 11% increase, while the Oncology division saw a 25% rise in revenue, totaling $15.612 billion. In the Generic Medicines segment, sales of the COVID-19 vaccine reached $5.353 billion, down 52% year-on-year. Despite this significant drop, there is no indication that the vaccine has fallen out of favor. Sales of apixaban totaled $7.366 billion, up 9%, although this product is nearing the end of its lifecycle. The pneumonia vaccine family generated $6.411 billion, a slight 1% decline. Notably, sales of Rimegepant, an oral CGRP inhibitor, surged to $1.263 billion, a 36% increase from 2022. The RSV bivalent vaccine Abrysvo brought in $755 million, down approximately $150 million from the previous year. Other pipeline products primarily consist of Pfizer's mature offerings, which generally experienced declines. In the Specialty Medicines sector, the drug Vyndaqel for transthyretin amyloidosis proved to be a significant revenue generator, contributing $5.411 billion in sales, a remarkable 64% increase. However, sales of tofacitinib fell 31% to $1.168 billion due to patent cliffs affecting the immediate-release formulation. The older drug ilaprazole saw sales of $690 million, down 17% year-on-year. Surprisingly, the antibiotic sufentanil still managed to generate $637 million in sales, despite a 4% decline, with a significant portion likely coming from China. The injectable ceftazidime-avibactam (Sivextro) achieved $586 million in sales, a 16% decline, marking it as the first cephalosporin antibiotic to surpass $500 million in sales since 2010. In the Oncology division, palbociclib generated $4.367 billion, down 8% year-on-year. Enzalutamide saw revenues of $2.039 billion, a 23% increase. The new drug padcev (enfortumab vedotin) performed exceptionally well, achieving $1.588 billion in sales during its first full fiscal year. Adcetris (brentuximab vedotin) also showed strong performance, with sales soaring to $1.089 billion. Axitinib generated $978 million, down 6%, while bosutinib remained stable at $645 million. Despite maintaining its position as the world's largest pharmaceutical company, Pfizer faces significant challenges regarding innovation and pipeline development. As of December 2024, the company's market capitalization stood at $150 billion, significantly lower than competitors such as Eli Lilly ($750 billion), Johnson & Johnson ($350 billion), AbbVie ($320 billion), Novo Nordisk ($300 billion), Merck ($250 billion), Roche ($220 billion), Novartis ($210 billion), and AstraZeneca ($200 billion). The pressure to innovate and expand its product pipeline remains a critical concern for Pfizer moving forward.

VaccineFinancial StatementDrug ApprovalClinical ResultBiosimilar

30 Jan 2025

·www.globenewswire.com

[Ad hoc announcement pursuant to Art. 53 LR] Roche reports strong 2024 results with 7% sales growth; fourth quarter marks third straight quarter of 9% growth

Basel, 30 January 2025 Group sales grew by 7%1 at constant exchange rates (CER; 3% in CHF), driven by strong demand for both medicines and diagnostics.Excluding COVID-19, Group sales increased by 9%. COVID-19 will not adversely impact our results from 2025 onwards.The fourth quarter was the third consecutive quarter of 9% sales growth, highlighting the very positive momentum.Pharmaceuticals Division sales rose by 8% (excluding COVID-19 medicine: 9%) on growing demand for newer medicines; top growth drivers were Vabysmo (severe eye diseases), Phesgo (breast cancer), Ocrevus (multiple sclerosis) and Hemlibra (haemophilia A).Diagnostics Division sales increased by 4%, reflecting the base effect of the sales of COVID-19 tests in the prior-year period; strong momentum in the Diagnostics Division’s base business continued with an increase of 8% due to higher demand for immunodiagnostic, pathology and molecular solutions.Core operating profit grew by 14% (8% in CHF), driven by higher sales, improved gross margin and effective cost management; core earnings per share rose by 7% (1% in CHF).Core earnings per share excluding the impact of the resolution of tax disputes in 2023 rose by 12%, exceeding the guidance for 2024.IFRS net income decreased by 19% (26% in CHF), mainly due to impairment charges to goodwill related to Flatiron Health and Spark Therapeutics.Operating free cash flow increased by 34% (CER) to CHF 20.1 billion.Highlights: Launch of cobas Mass Spec, a transformative innovation in mass spectrometryEU approval for Vabysmo prefilled syringeUS acceptance of supplemental Biologics License Application for Columvi combinationPositive data on blood cancer medicines Columvi, Lunsumio and Polivy, eye medicine Vabysmo, Duchenne muscular dystrophy medicine Elevidys and breast cancer therapy ItovebiAcquisition of Poseida Therapeutics for a range of potentially first- and best-in-class cell therapies across oncology, immunology and neurologyCE mark for new and updated molecular cobas 6800/8800 systems for enhanced laboratory efficiency and testing capabilities Board proposes dividend increase to CHF 9.70. If approved by shareholders, this would be the 38th consecutive dividend increase. Outlook for 2025 Roche (SIX: RO, ROG; OTCQX: RHHBY) expects an increase in Group sales in the mid single digit range (CER). Core earnings per share are targeted to develop in the high single digit range (CER). Roche expects to further increase its dividend in Swiss francs. Key figures CHF millions % change January–December 2024 2023 At CER1 In CHF Group sales 60,495 58,716 7 3 Pharmaceuticals Division 46,171 44,265 8 4 Diagnostics Division 14,324 14,451 4 -1 Core operating profit 20,823 19,240 14 8 Core EPS – diluted (CHF) 18.80 18.57 7 1 IFRS net income 9,187 12,358 -19 -26 Roche CEO Thomas Schinecker: “2024 was a strong year for Roche. In the fourth quarter, we continued our very positive momentum for the third consecutive quarter with Group sales growth of 9% (CER). Core earnings per share exceeded the guidance raised at half year. We are proud to have made a positive impact on patients’ lives in 2024 with the launch of two new medicines – Itovebi for a hard-to-treat breast cancer and PiaSky for a serious blood disorder – as well as our new solution for continuous blood glucose monitoring and our innovative system for fully automated mass spectrometry. Last year, we substantially strengthened our pipeline through the acceleration of internal key programmes and new partnerships and acquisitions such as Poseida Therapeutics for cell therapy in oncology and autoimmune diseases. Roche is well positioned for future growth.” Group resultsIn 2024, Roche achieved sales growth of 7% (3% in CHF) to CHF 60.5 billion. Core earnings per share rose by 12%, excluding the base effect of the resolution of tax disputes in 2023. Including this impact, core earnings per share increased by 7%. The appreciation of the Swiss franc against most currencies had a significant impact on the results reported in Swiss francs compared to constant exchange rates. Strong demand for both pharmaceutical products and diagnostic solutions more than made up for the expected decline of CHF 1.1 billion in COVID-19-related sales and an impact of CHF 1.0 billion from the loss of exclusivity on Avastin (various types of cancer), Herceptin (breast and gastric cancer), MabThera/Rituxan (blood cancer, rheumatoid arthritis), Esbriet (lung disease), Lucentis (severe eye diseases) and Actemra/RoActemra (rheumatoid arthritis, COVID-19). Core operating profit rose by 14% (8% in CHF) to CHF 20.8 billion, driven by higher sales, improved gross margin and effective cost management. IFRS net income decreased by 19% (26% in CHF) to CHF 9.2 billion, mainly due to impairment charges to goodwill of CHF 3.2 billion related to Flatiron Health and Spark Therapeutics. Sales in the Pharmaceuticals Division increased by 8% to CHF 46.2 billion, with newer medicines for severe diseases continuing their strong growth. The top four growth drivers – Vabysmo, Phesgo, Ocrevus and Hemlibra – achieved total sales of CHF 16.9 billion. This represents a plus of CHF 3.3 billion at CER compared to 2023. Vabysmo, launched in early 2022, continued to be a major growth driver, generating sales of CHF 3.9 billion on growing demand in all regions. Sales of Avastin, Herceptin, MabThera/Rituxan, Esbriet, Lucentis and Actemra/RoActemra decreased by a combined CHF 1.0 billion (CER) due to the impact of loss of exclusivity. Sales of the COVID-19 medicine Ronapreve were minimal compared to sales in Japan of CHF 0.5 billion in 2023. In the United States, sales rose by 9%. Vabysmo, Ocrevus, Xolair (allergies) and Polivy were the main growth drivers. This growth more than compensated for the decline in sales of Lucentis (severe eye diseases) and lower sales of medicines with expired patents. Sales in Europe grew 8% as sales growth due to the continued rollout of Vabysmo and the uptake of Phesgo, Ocrevus, Hemlibra and Evrysdi (spinal muscular atrophy) more than compensated for the decline in sales of medicines with expired patents, the impact of biosimilar competition on Actemra/RoActemra sales and lower sales of Perjeta (breast cancer) due to ongoing conversion of patients to Phesgo. In Japan, sales decreased by 16%, reflecting the base effect of Ronapreve sales in the first half of 2023 that did not reoccur in 2024. Excluding Ronapreve, sales in Japan fell by 2% as price cuts and biosimilar and generic erosion more than offset the growth in sales of Phesgo, Vabysmo and Hemlibra. Sales in the International region grew by 17%, led by China, Canada and Brazil. In China, sales rose by 6%, driven by continued sales growth of Perjeta, Alecensa (early-stage lung cancer) and Avastin as well as higher sales of Xofluza (influenza) and the rollout of Polivy. The Diagnostics Division’s base business sales increased by 8%, led by the increased demand for immunodiagnostic products and by higher sales of clinical chemistry tests, advanced staining solutions and companion diagnostics. Overall, the Diagnostics Division reported sales growth of 4% to CHF 14.3 billion, reflecting the anticipated drop in demand for COVID-19-related products (sales of CHF 0.2 billion in 2024 compared to CHF 0.8 billion in 2023). Sales in the Europe, Middle East and Africa (EMEA) region increased by 5%, driven by higher sales of immunodiagnostic products, clinical chemistry tests and advanced staining solutions. In North America, there was growth in the underlying base business across customer areas. Sales in Asia-Pacific decreased by 5% as higher sales of immunodiagnostic products were offset by the expected drop in demand for COVID-19-related tests. Pharmaceuticals Division: pipelineWith 71 new molecular entities (NMEs) and a total of 122 projects, Roche has a promising pipeline with a wide variety of therapeutic approaches. Pharmaceuticals research and development (R&D) expenditure grew by 1% to CHF 11.1 billion (Group R&D: 1% to CHF 13.0 billion). Oncology remained the primary area for R&D, with substantial investments also in the areas of immunology and cardiovascular, renal and metabolism. Pharmaceuticals: key developments Compound Milestone Regulatory VabysmoSevere eye diseases Vabysmo prefilled syringe (PFS) is now approved in the EU for three retinal conditions that can cause blindness Vabysmo PFS is the first and only prefilled syringe containing a bispecific antibody, offering a convenient alternative to currently available Vabysmo vials.Vabysmo has demonstrated rapid and robust vision and anatomical improvements in neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME) and retinal vein occlusion (RVO).The ready-to-use Vabysmo PFS is co-packaged with the only CE-marked needle specifically designed for intravitreal injection. More information: Media Release, 13 December 2024 ColumviBlood cancer FDA accepts supplemental Biologics License Application for Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) The application is based on data from the phase III STARGLO study where Columvi plus chemotherapy showed a statistically significant and clinically meaningful improvement in overall survival.This regimen could provide an off-the-shelf, fixed-duration treatment option for patients to start soon after diagnosis, which is important for those who are at high risk of disease progression.Improving survival outcomes is needed for people with an aggressive disease like relapsed or refractory DLBCL, especially those who are not eligible for transplant. More information: Media Release, 5 December 2024 Phase III, pivotal and other key read-outs ItovebiBreast cancer Itovebi demonstrated statistically significant and clinically meaningful overall survival benefit in a certain type of HR-positive advanced breast cancer Updated results for overall survival (OS) – a key secondary endpoint – reinforce the significant benefit of the regimen based on Itovebi (inavolisib) for patients with advanced PIK3CA-mutated, HR-positive, HER2-negative breast cancer in the first-line setting.Primary analysis showed the regimen based on Itovebi reached statistical significance, more than doubling progression-free survival in this patient population.Full OS results from the phase III INAVO120 study will be presented at an upcoming medical meeting. More information: Media Release, 28 January 2025 ElevidysDuchenne muscular dystrophy Roche announces new results from EMBARK, demonstrating significant sustained benefits of Elevidys in ambulatory individuals with Duchenne muscular dystrophy (DMD) Across three key functional outcomes, North Star Ambulatory Assessment (NSAA), Time to Rise (TTR) and 10-metre walk/run (10MWR), results were statistically significant and clinically meaningful two years after treatment with Elevidys, compared to a pre-specified propensity-weighted untreated external control group.Functional differences between individuals treated with Elevidys and those in the external control group increased between one year and two years after treatment.No new safety signals were observed, further reinforcing the consistent and manageable safety profile observed with Elevidys to date. More information: Media Release, 27 January 2025 PrasinezumabParkinson’s disease Phase IIb study of prasinezumab misses primary endpoint, but suggests possible benefit in early-stage Parkinson’s disease PADOVA study showed numerical delay in motor progression and positive trends on multiple secondary and exploratory endpoints.Prasinezumab continues to be well tolerated and no new safety signals were observed.Roche is further evaluating the data and will work together with health authorities to determine next steps. More information: Media Release, 19 December 2024 Columvi/LunsumioBlood cancer New and updated data for fixed-duration Columvi and Lunsumio presented at annual meeting of American Society of Hematology (ASH) 2024 reinforce their potential to improve outcomes for people with lymphoma Long-term data confirm fixed-duration Columvi and Lunsumio achieve durable remissions beyond the end of treatment, with real-world data suggesting reduced treatment-related travel burden due to less frequent dosing.First presentation of Lunsumio given subcutaneously showed non-inferiority to intravenous treatment with a consistent safety profile, potentially providing an additional outpatient option with a shorter administration time.Positive results for Roche’s two bispecifics antibodies validate the company’s efforts to provide multiple treatment options that suit the diverse needs of lymphoma patients and healthcare providers. More information: Media Release, 10 December 2024 PolivyBlood cancer Five-year results confirm Polivy combination therapy as new standard of care for previously untreated aggressive lymphoma Exploratory long-term follow-up analysis of the phase III POLARIX study indicated a positive trend in overall survival in favour of Polivy in combination with R-CHP for the first-line treatment of people with DLBCL.Patients treated with Polivy in combination with R-CHP required fewer subsequent treatments, which potentially reduces the burden on patients and healthcare systems.These encouraging five-year results continue to highlight the potential of this Polivy combination to improve outcomes in the first-line treatment of people with DLBCL, an area that had little advancement in nearly two decades. More information: Media Release, 8 December 2024 TiragolumabLung cancer Roche reports update on phase III SKYSCRAPER-01 study results SKYSCRAPER-01 is a global phase III, randomised, double-blind study evaluating tiragolumab plus Tecentriq compared to Tecentriq alone in 534 patients with PD-L1-high previously untreated, locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC). The study did not reach the primary endpoint of overall survival at the final analysis. More information: Media Release, 26 November 2024 VabysmoSevere eye diseases Vabysmo improves vision in under-represented populations with DME in a first-of-its-kind study The ELEVATUM study showed clinically meaningful improvement in vision and reduction in retinal fluid in African American, Black, Hispanic and Latino people with DME treated with Vabysmo. Efficacy and safety from this phase IV study were consistent with data from the Vabysmo phase III DME studies.These racial and ethnic groups are disproportionately affected by diabetes and are at higher risk of developing DME, a leading cause of vision loss. More information: Media Release, 18 October 2024 Other Poseida Therapeutics tender offer Roche purchases shares in tender offer for Poseida Therapeutics Roche’s wholly owned subsidiary Blue Giant Acquisition Corp. accepted for payment all shares validly tendered and not validly withdrawn pursuant to its tender offer for all outstanding shares of common stock of Poseida Therapeutics at a price of USD 9.00 per share in cash, plus a non-tradeable contingent value right (CVR), to receive certain contingent payments of up to an aggregate of USD 4.00 per share in cash. The tender offer expired at one minute following 11:59 p.m., New York City time, on 7 January 2025, and was not extended. More information: Media Release, 8 January 2025 Poseida Therapeutics tender offer Roche commences tender offer for all shares of Poseida Therapeutics for USD 9.00 per share in cash, plus a non-tradeable contingent value right for up to USD 4.00 per share in cash The tender offer is being made pursuant to the previously announced merger agreement dated 25 November 2024.Following the successful completion of the tender offer, any shares not acquired in the tender offer will be acquired in a second-step merger at the same price of USD 9.00 per share, plus the contingent value right. The transaction is expected to close in the first quarter of 2025. More information: Media Release, 9 December 2024 Poseida Therapeutics acquisition Roche enters into a definitive agreement to acquire Poseida Therapeutics, including cell therapy candidates and related platform technologies The acquisition supports Roche’s pharmaceuticals strategy and allows for a range of potentially first- and best-in-class therapies across oncology, immunology and neurology, uniquely positioning Roche in the new field of donor-derived off-the-shelf cell therapies.Roche will acquire Poseida Therapeutics for USD 9.00 per share in cash at closing, which represents a total equity value of approximately USD 1.0 billion. Stockholders will also receive a non-tradeable contingent value right for up to an aggregate of USD 4.00 per share in cash, representing a total deal value of up to approximately USD 1.5 billion. More information: Media Release, 26 November 2024 ItovebiBreast cancer NEJM publishes landmark phase III results for Itovebi, showing more than doubling of progression-free survival in a certain type of HR-positive advanced breast cancer The regimen based on Itovebi (inavolisib) demonstrated a statistically significant and clinically meaningful benefit, reducing the risk of disease worsening or death by 57% compared with palbociclib and fulvestrant alone in the INAVO120 study.The FDA recently approved the regimen based on Itovebi as a first-line treatment for people with HR-positive, HER2-negative breast cancer with a PIK3CA mutation, one of the most common gene mutations in HR-positive disease. More information: Media Release, 31 October 2024 Pharmaceuticals sales Sales CHF millions As % of sales % change January–December 2024 2023 2024 2023 At CER In CHF Pharmaceuticals Division 46,171 44,265 100.0 100.0 8 4 United States 24,774 23,259 53.7 52.5 9 7 Europe 8,832 8,306 19.1 18.8 8 6 Japan 2,874 3,745 6.2 8.5 -16 -23 International* 9,691 8,955 21.0 20.2 17 8 *Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others Top 20 best-selling pharmaceuticals Total United States Europe Japan International CHF m % CHF m % CHF m % CHF m % CHF m % OcrevusMultiple sclerosis 6,744 9 4,819 5 1,306 14 - - 619 29 HemlibraHaemophilia A 4,503 12 2,654 9 926 11 367 8 556 41 VabysmoEye diseases (nAMD, DME, RVO) 3,864 68 2,940 57 622 128 125 40 177 168 TecentriqCancer immunotherapy 3,640 0 1,763 -7 863 4 380 0 634 23 Perjeta3Breast cancer 3,616 1 1,345 3 646 -15 116 -40 1,509 15 Actemra/RoActemra3RA, COVID-19 2,645 5 1,331 11 658 -14 309 9 347 19 Xolair3Asthma 2,470 16 2,470 16 - - - - - - Kadcyla3Breast cancer 1,998 7 765 3 564 -1 98 5 571 23 PhesgoBreast cancer 1,740 62 570 38 738 40 136 ** 296 111 EvrysdiSpinal muscular atrophy 1,631 18 588 19 572 14 93 10 378 25 AlecensaLung cancer 1,548 7 525 15 284 -1 198 3 541 7 Herceptin3Breast and gastric cancer 1,381 -11 265 -18 303 -13 14 -50 799 -6 MabThera/Rituxan3Blood cancer, RA 1,379 -13 842 -13 150 -15 17 -25 370 -10 Avastin3Various cancer types 1,233 -17 383 -19 85 -11 197 -32 568 -10 Activase/TNKase3Cardiac diseases 1,202 5 1,140 5 - - - - 62 5 PolivyBlood cancer 1,121 39 568 70 192 13 198 -4 163 76 Gazyva/Gazyvaro3Blood cancer 910 16 463 20 245 9 29 -15 173 23 Pulmozyme3Cystic fibrosis 455 4 303 2 73 -3 1 21 78 22 CellCept3Immunosuppressant 399 7 23 -22 124 2 40 -3 212 17 Mircera3Anaemia related to kidney disease 397 -3 - - 42 -3 38 -23 317 1 ** Over 500%DME: diabetic macular edema / nAMD: neovascular or ‘wet’ age-related macular degeneration / RVO: retinal vein occlusion / RA: rheumatoid arthritis Diagnostics: key developments Product Milestone cobas liat STI multiplex assay panelsSexually transmitted infections Roche receives FDA clearance with CLIA waiver for cobas liat molecular tests to diagnose sexually transmitted infections at the point of care More than 1 million curable sexually transmitted infections (STIs) are acquired every day worldwide in people 15–49 years old, most of which are asymptomatic.FDA CLIA-waived tests broaden access to accurate, easy-to-use diagnostics for all patients in decentralised settings like urgent care centres, retail clinics and community health venues.The tests use highly sensitive gold-standard PCR technology, providing results in 20 minutes to allow healthcare providers to confidently diagnose and determine appropriate treatment in the same visit. More information: Media Release, 22 January 2025 cobas Mass Spec Roche transforms mass spectrometry diagnostics with launch of cobas Mass Spec solution Roche launched its cobas Mass Spec solution, bringing mass spectrometry to the routine clinical lab.Clinical mass spectrometry testing offers unparalleled sensitivity and specificity, providing clinicians with additional diagnostic insights.cobas Mass Spec solution will offer a fully automated, integrated and standardised workflow with IVDR-compliant assays. More information: Media Release, 18 December 2024 cobas 6800/8800 systems 2.0Various tests Roche receives CE mark for new molecular cobas 6800/8800 systems upgrade, enhancing laboratory efficiency and testing capabilities The new cobas 6800/8800 systems 2.0 upgrade enhances throughput and run flexibility, enables sample prioritisation and is available for existing systems in healthcare settings around the world.Laboratories can now perform a wider range of tests on a single solution, thereby simplifying laboratory logistics and helping to optimise the use of resources. More information: Media Release, 13 December 2024 Elecsys Amyloid Plasma PanelAlzheimer’s disease Roche presents new data at the Clinical Trials on Alzheimer’s Disease (CTAD) conference, demonstrating its growing momentum in diagnostics for Alzheimer’s disease New data highlight the potential of the Roche Elecsys Amyloid Plasma Panel and Elecsys pTau181 for ruling out Alzheimer’s disease-related amyloid pathology with very good accuracy.In the largest worldwide clinical trial of its kind, the blood-based test showed very good accuracy in ruling out Alzheimer’s pathology in those being investigated for the disease, potentially avoiding the need for further invasive and unnecessary tests.Results further demonstrate Roche’s commitment to bringing diagnostic clarity for Alzheimer’s disease to people at an early stage of cognitive decline. More information: Media Release, 31 October 2024 Diagnostics sales Sales CHF millions As % of sales % change January–December 2024 2023 2024 2023 At CER In CHF Diagnostics Division 14,324 14,451 100.0 100.0 4 -1 Customer Areas4 Core Lab 8,004 7,750 55.9 53.6 8 3 Molecular Lab5 2,590 2,567 18.1 17.8 4 1 Near Patient Care6 2,167 2,746 15.1 19.0 -17 -21 Pathology Lab 1,563 1,388 10.9 9.6 17 13 Regions Europe, Middle East, Africa 4,822 4,768 33.7 33.0 5 1 North America 4,335 4,173 30.3 28.9 6 4 Asia–Pacific 4,099 4,496 28.6 31.1 -5 -9 Latin America 1,068 1,014 7.4 7.0 22 5 More information on Roche performance in 2024: 2024 Finance Report2024 Annual Report2024 presentationAppendix with tables About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law.References[1] Unless otherwise stated, all growth rates and comparisons to the previous year in this document are at constant exchange rates (CER: average rates 2023) and all total figures quoted are reported in CHF.[2] Pharmaceuticals Division base business: excluding COVID-19 medicine Ronapreve. Diagnostics Division base business: excluding COVID-19-related products.[3] Products launched before 2015.[4] Core Lab: diagnostics solutions in the areas of immunoassays, clinical chemistry and CustomBiotech.Molecular Lab: diagnostics solutions for pathogen detection and monitoring, donor screening, sexual health and genomics, genomic tumour profiling.Near Patient Care: diagnostics solutions in emergency rooms, medical practices and directly with patients, including integrated personalised diabetes management.Pathology Lab: diagnostics solutions for tissue biopsies and companion diagnostics.[5] Sales in the Molecular Lab customer area include sales from the Foundation Medicine business, which moved under the responsibility of the Diagnostics Division from the Pharmaceuticals Division effective 1 January 2024. The comparative information for 2023 has been restated accordingly.[6] Sales in the new Near Patient Care customer area include sales from Diabetes Care and the Point of Care business, both previously shown as separate customer areas. The comparative information for 2023 has been restated accordingly. Cautionary statement regarding forward-looking statementsThis document contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this document, such as: (1) pricing and product initiatives of competitors; (2) legislative and regulatory developments and economic conditions; (3) delay or inability in obtaining regulatory approvals or bringing products to market; (4) fluctuations in currency exchange rates and general financial market conditions; (5) uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side effects of pipeline or marketed products; (6) increased government pricing pressures; (7) interruptions in production; (8) loss of or inability to obtain adequate protection for intellectual property rights; (9) litigation; (10) loss of key executives or other employees; and (11) adverse publicity and news coverage. The statement regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche. Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com Hans Trees, PhDPhone: +41 79 407 72 58 Sileia UrechPhone: +41 79 935 81 48 Nathalie AltermattPhone: +41 79 771 05 25 Lorena CorfasPhone: +41 79 568 24 95 Simon GoldsboroughPhone: +44 797 32 72 915 Karsten KleinePhone: +41 79 461 86 83 Nina MählitzPhone: +41 79 327 54 74 Kirti PandeyPhone: +49 172 636 72 62 Yvette PetillonPhone: +41 79 961 92 50 Dr Rebekka SchnellPhone: +41 79 205 27 03 Roche Investor Relations Dr Bruno EschliPhone: +41 61 687 52 84e-mail: bruno.eschli@roche.com Dr Sabine BorngräberPhone: +41 61 688 80 27e-mail: sabine.borngraeber@roche.com Dr Birgit MasjostPhone: +41 61 688 48 14e-mail: birgit.masjost@roche.com Investor Relations North America Loren KalmPhone: +1 650 225 32 17e-mail: kalm.loren@gene.com Attachments 30012025_MR_FY Roche 2024_EN Communications appendix tables_FY 2024 Sales + Results

Clinical ResultPhase 3Drug ApprovalPhase 2Acquisition

100 Deals associated with Palbociclib

External Link

KEGG	Wiki	ATC	Drug Bank
D10372	Palbociclib	L01XE33	DB09073

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Breast cancer recurrent	JP	Pfizer Japan, Inc.	27 Sep 2017
Hormone receptor positive HER2 negative breast cancer	US	Pfizer Inc.	19 Feb 2016
ER-positive/HER2-negative Breast Cancer	US	Pfizer Inc.	03 Feb 2015

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Human Papillomavirus-Related Squamous Cell Carcinoma	Phase 3	US	Pfizer Inc.	06 Apr 2022
Squamous Cell Carcinoma of Head and Neck	Phase 3	US	Pfizer Inc.	06 Apr 2022
Squamous cell carcinoma of head and neck metastatic	Phase 3	US	Pfizer Inc.	06 Apr 2022
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	AT	Pfizer Inc.	27 Aug 2019
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	FR	Pfizer Inc.	27 Aug 2019
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	HU	Pfizer Inc.	27 Aug 2019
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	IT	Pfizer Inc.	27 Aug 2019
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	ES	Pfizer Inc.	27 Aug 2019
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	CH	Pfizer Inc.	27 Aug 2019
HER2-negative breast cancer	Phase 3	JP	Pfizer Inc.	16 Jul 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03774472 (CTgov)	Phase 1/2	ER-positive/HER2-negative Breast Cancer \| Metastatic breast cancer	15	HCQ (HCQ at 400 mg)	ivbrilbcgm(hjsspgkxiz) = spuujelrte bnbjrqljsr (zaebhharop, icbsocgibu - eclbtbllpr) View more	-	17 Feb 2025
				HCQ (HCQ at 600 mg)	ivbrilbcgm(hjsspgkxiz) = lrldvrnmwq bnbjrqljsr (zaebhharop, abgebtjmsz - dkkjoaxmce) View more
Pubmed \| Future Oncol	Not Applicable	Metastatic breast cancer	-	Palbociclib-fulvestrant	ssdkeqxwtu(qixnmywpgc) = agzxzihood hiyzuybape (xoufqhzqdc, 15.2 - 23.6)	-	02 Jan 2025
NCT04256941 (CTgov)	Phase 2	Metastatic breast cancer	4	Fulvestrant (Fulvestrant)	kjhxvuryqw(kjoigoewkk) = dutogwfpfb zunrdnkwpf (lsclwecjvo, tunyejhrmm - erseignliy) View more	-	27 Dec 2024
				palbociclib (Ibrance)+fulvestrant (Continuing AI After Randomization)	kjhxvuryqw(kjoigoewkk) = kfzfercftc zunrdnkwpf (lsclwecjvo, lzfzcmsxrp - tzewhenhtg) View more
NCT02297438 (PALOMA-4, Pubmed \| Chin Med J (Engl))	Phase 3	ER-positive/HER2-negative Breast Cancer First line ER+ \| HER2−	-	Palbociclib plus Letrozole	yyugldcpua(wtlpiasjqm): mean change from baseline = 0.97 (95% CI, 0.05 - 1.89), P-Value = 0.038 View more	Positive	19 Dec 2024
				Placebo plus Letrozole
NCT03644186 (TOUCH, CTgov)	Phase 2	ER-positive/HER2-positive Breast Cancer \| HER2 Positive Breast Cancer \| Hormone receptor positive HER2 positive breast cancer	147	Trastuzumab+Paclitaxel+pertuzumab (Paclitaxel Plus Trastuzumab and Pertuzumab)	mxczgyikzs(wvldvipnfu) = gzlbkjadmk ycvoztiami (swpzeqdmld, cpnzenphwg - dmwebukspm) View more	-	13 Dec 2024
				Trastuzumab+Letrozole+palbociclib+pertuzumab (Palbociclib Plus Letrozole Plus Trastuzumab and Pertuzumab)	mxczgyikzs(wvldvipnfu) = yucssqltcc ycvoztiami (swpzeqdmld, nfhmippxqd - qqeftepifh) View more
NCT02947685 (PATINA, Company_Website) Manual	Phase 3	Hormone receptor positive HER2 positive breast cancer First line HER2 Positive \| Hormone Receptor Positive	518	IBRANCE + anti-HER2 therapy + endocrine therapy	mjkfwlkmsb(vbtgkxwirp) = ofwpccffpf qgebcywmno (eiwvvocpup, 32.4 - 60.9) View more	Positive	12 Dec 2024
				Anti-HER2 therapy + endocrine therapy	mjkfwlkmsb(vbtgkxwirp) = lsnljkkrpq qgebcywmno (eiwvvocpup, 23.3 - 38.6) View more
NCT06390839 (CTgov)	Phase 2	Refractory Malignant Solid Neoplasm \| Advanced Malignant Solid Neoplasm \| Advanced Lymphoma ... View more	43	Computed Tomography+palbociclib	qzamgejcsr(echotyyvli) = sktiwsnfws jouhoqbmez (lrsbkizzxd, gxmwhzuabb - bcgnofpnio) View more	-	10 Dec 2024
NCT02491983 (PARSIFAL, CTgov)	Phase 2	Metastatic HER2-Negative Breast Carcinoma \| ER-positive/HER2-negative Breast Cancer \| Metastatic breast cancer	486	Letrozole+palbociclib (Arm A)	iogfailoiy(milynxtdlt) = ujteyrfxpz spuhiglucb (wosybedkci, esnvpwvzvp - bjmqgtdhxn) View more	-	09 Dec 2024
				Fulvestrant+palbociclib (Arm B)	iogfailoiy(milynxtdlt) = jiwgxiemtw spuhiglucb (wosybedkci, dqffqhdgzc - iyplicxuva) View more
ESMO_ASIA2024 Manual	Not Applicable	Hormone receptor positive HER2 negative breast cancer First line HER2 Negative \| Hormone Receptor Positive	377	Palbociclib	tbsixcvwem(jamxxjwexf) = kydnskfhxi hvmfzobzog (zukpgteekh ) View more	Similar	07 Dec 2024
				Ribociclib	tbsixcvwem(jamxxjwexf) = ldzecdgmtd hvmfzobzog (zukpgteekh ) View more
NCT05361655 (Pubmed \| Oncologist)	Not Applicable	Cardiovascular Diseases \| Metastatic breast cancer First line HR+ \| HER2−	469	Palbociclib plus aromatase inhibitor	bqhjhcapkl(umxlelxfqu) = xmuldamguj mgaibqsnxr (yfzyyhdmpb ) View more	Positive	06 Dec 2024
				Aromatase inhibitor alone	bqhjhcapkl(umxlelxfqu) = ipfcyxqyiu mgaibqsnxr (yfzyyhdmpb ) View more

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