[Translation] A multicenter, randomized, double-blind, placebo-controlled, phase III study evaluating the efficacy and safety of inavolisib combined with a CDK4/6 inhibitor and letrozole versus placebo combined with a CDK4/6 inhibitor and letrozole in patients with endocrine-sensitive PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer

评价inavolisib 联合CDK4/6i 和来曲唑对比安慰剂联合 CDK4/6i 和来曲唑的有效性

[Translation]

To evaluate the effectiveness of inavolisib combined with CDK4/6i and letrozole versus placebo combined with CDK4/6i and letrozole

Start Date24 Mar 2025

Sponsor / Collaborator

F. Hoffmann-La Roche Ltd.

[+1]

NCT06790693

/ Not yet recruitingPhase 3

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer (ABC).

Start Date28 Feb 2025

Sponsor / Collaborator-

NCT05708235

/ Active, not recruitingPhase 2

A Proof of Concept Study to Evaluate Treatments' Efficacy by Monitoring Minimal Residual Disease Using ctDNA in HR-positive/HER2-negative Early Breast Cancer Population

This trial is a multicenter, open-label, non-comparative, phase II, biomarker-driven adjuvant treatment study involving the periodic collection and analysis of blood samples from patients with HR-positive/HER2-negative early-stage BC at higher risk of relapse, who have undergone surgery within the previous five years, with no evidence of locoregional, contralateral, or distant disease.
The study design is composed by an initial pre-screening phase, a molecular follow-up phase (ctDNA surveillance phase), and an interventional therapeutic phase (treatment phase).
After informed consent is obtained, a total of1,260 eligible patients will enter a ctDNA surveillance in which primary tumor tissue and matched normal blood will be collected from each patient to obtain a patient-specific somatic mutations panel (tumor signature).
At the event of ctDNA positivity, patients will be screened to enter the treatment phase of the study. Upon confirmed eligibility, a total of 40 patients will be allocated in one of the following trial's arms adopting a sequential recruitment strategy:
Arm A: Control Arm (N=10) Arm B: Experimental Arm with giredestrant (N=10) Arm C: Experimental Arm with giredestrant + abemaciclib (N=10) Arm D: Experimental Arm with giredestrant + inavolisib (N=10)
If the strategy of ctDNA monitoring enables physicians to identify patients at high risk of relapse and assess whether treatment at molecular relapse can improve outcome, new cohorts may be added to the study.

Start Date01 Apr 2024

Sponsor / Collaborator

Medica Scientia Innovation Research SL

100 Clinical Results associated with Inavolisib

100 Translational Medicine associated with Inavolisib

100 Patents (Medical) associated with Inavolisib

Literatures (Medical) associated with Inavolisib

01 May 2025·European Journal of Cancer

Inavolisib plus letrozole or fulvestrant in PIK3CA-mutated, hormone receptor-positive, HER2-negative advanced or metastatic breast cancer (GO39374): An open-label, multicentre, dose-escalation and dose-expansion phase 1/1b study

Article

Author: Peters, Ubong ; Song, Kyung ; Hutchinson, Katherine E ; Hilz, Stephanie ; Krop, Prof Ian E ; Schutzman, Jennifer L ; Schmid, Prof Peter ; Turner, Prof Nicholas ; Jhaveri, Komal L ; Royer-Joo, Stephanie ; Shankar, Noopur ; Accordino, Melissa K ; Italiano, Prof Antoine ; Oliveira, Mafalda ; Dey, Anwesha ; Hamilton, Erika ; Kalinsky, Prof Kevin ; Bedard, Philippe L ; Aimi, Junko ; Cheeti, Sravanthi ; Juric, Dejan ; Jin, Yanling ; Cervantes, Prof Andrés ; Gambardella, Valentina ; Saura, Cristina ; Varga, Andrea

BACKGROUNDA variety of treatment options continue to be explored in the post-cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) setting for hormone receptor (HR)-positive, HER2-negative locally advanced/metastatic breast cancer (LA/mBC), and optimal sequencing of therapies remains to be determined. This phase 1/1b study examined inavolisib, a potent and selective PI3Kα inhibitor that promotes mutated p110α degradation, alone and in combination with endocrine therapy (ET) ± palbociclib, in PIK3CA-mutated, HR-positive, HER2-negative LA/mBC. We report data on inavolisib plus ET, including in patients who had previously received a CDK4/6i.METHODSWomen age ≥ 18 years received inavolisib (6 mg/9 mg orally once daily [PO QD]) plus letrozole (2·5 mg PO QD), or inavolisib (9 mg PO QD) plus fulvestrant (500 mg intramuscularly on Days 1 and 15 of Cycle 1 then every 4 weeks), until unacceptable toxicity/disease progression.PRIMARY ENDPOINTsafety and tolerability.FINDINGSThirty-seven and 60 patients were enrolled in the inavolisib plus letrozole and inavolisib plus fulvestrant arms, respectively. Overall, treatment-related adverse events (mostly low grade) occurred in 94·6 % and 93·3 % of patients, respectively; the most frequent (≥10 % of patients in either arm) were hyperglycaemia, stomatitis, nausea, and diarrhoea. Confirmed objective response rates in patients with measurable disease were 9·7 % and 25·9 %, respectively; median progression-free survival was 3·7 and 7·3 months. Among patients with previous CDK4/6i therapy (29/37 and 58/60 patients, respectively), confirmed objective response rates were 13·0 % and 25·0 %; median progression-free survival was 3·7 and 7·1 months. No drug-drug interactions were observed for any study treatment. Paired baseline and Cycle 1 Day 15 tumour biopsies and circulating tumour DNA analyses demonstrated the impact of study treatment on pharmacodynamic/pathophysiologic biomarkers of response.INTERPRETATIONInavolisib plus ET demonstrated a manageable safety profile and encouraging preliminary anti-tumour activity in patients with PIK3CA-mutated, HR-positive, HER2-negative LA/mBC, including those in the post-CDK4/6i setting.

01 Apr 2025·SLAS Discovery

Combinatorial screen of targeted agents with the PI3K inhibitors inavolisib, alpelisib, duvelisib, and copanlisib in multi-cell type tumor spheroids

Article

Author: Said, Rabih ; Takebe, Naoko ; Moscow, Jeffrey A ; Dexheimer, Thomas S ; Coussens, Nathan P ; Teicher, Beverly A ; Davoudi, Zahra ; Doroshow, James H ; Silvers, Thomas ; Morris, Joel

Dysregulation of the phosphatidylinositol 3-kinase (PI3K) pathway is a key contributor to cancer, making PI3K inhibitors a promising approach for targeted therapy. The selectivity of available inhibitors varies across different PI3K isoforms. Alpelisib and inavolisib are selective for the α-isoform, while duvelisib targets the δ- and γ-isoforms, and copanlisib is a pan-PI3K inhibitor, active against all isoforms. This study investigated the activity of these four PI3K inhibitors in combination with other targeted agents using multi-cell type tumor spheroids composed of 60% malignant cells, 25% endothelial cells, and 15% mesenchymal stem cells. Twenty-nine tumor spheroid models were evaluated, including twenty-six patient-derived cancer cell lines from the NCI Patient-Derived Models Repository and three established cell lines from the NCI-60 human tumor cell line panel. Additive and/or synergistic effects were observed with alpelisib or inavolisib or copanlisib in combination with a RAS/MEK/ERK pathway inhibitor, either selumetinib (MEK), ravoxertinib (ERK 1/2), or tovorafenib (DAY101, RAF). Combinations of each of these three PI3K inhibitors with the KRAS mutation specific inhibitors MTRX1133 (KRAS G12D) or sotorasib (KRAS G12C) had selective activity in cell lines harboring the corresponding target. Lastly, combination effects were observed from vertical inhibition of the PI3K/AKT/mTOR pathway with a PI3K inhibitor in combination with either the mTORC1/2 inhibitor sapanisertib or an AKT inhibitor, ipatasertib or afuresertib.

01 Feb 2025·Drugs

Inavolisib: First Approval

Review

Author: Blair, Hannah A

Inavolisib (Itovebi^™) is an orally administered, phosphatidylinositol-3-kinase alpha (PI3Kα) inhibitor being developed by Genentech, a member of the Roche group, for the treatment of solid tumours. On 10 October 2024, inavolisib received its first approval in the USA in combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy. In the EU and other countries worldwide, regulatory review of inavolisib is currently underway. This article summarises the milestones in the development of inavolisib leading to this first approval for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer.

News (Medical) associated with Inavolisib

13 Mar 2025

·www.prnewswire.com

VERZENIO's Market Potential Soars as Demand for CDK4/6 Inhibitors Grows | DelveInsight

As VERZENIO gains traction in early-stage treatments and broadens its approved uses, its revenue is expected to keep growing. While the global CDK4/6 inhibitor market remains highly competitive, VERZENIO's distinct clinical advantages and ongoing studies could contribute to further market expansion. LAS VEGAS, March 13, 2025 /PRNewswire/ -- DelveInsight's " VERZENIO Market Size, Forecast, and Market Insight Report" highlights the details around VERZENIO, which is a targeted treatment known as a CDK4/6 inhibitor. The drug is a non-chemotherapy oral tablet. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of VERZENIO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Eli Lilly and Company's VERZENIO (abemaciclib) Overview VERZENIO (abemaciclib) is a prescription medication used to treat adults with HR-positive, HER2-negative breast cancer that has metastasized (spread to other parts of the body). It is administered orally and is prescribed in combination with an aromatase inhibitor as an initial endocrine-based therapy. Additionally, the drug is being developed for the treatment of prostate cancer. VERZENIO is approved for the following indications: In combination with endocrine therapy for the adjuvant treatment of adults with HR+/HER2-, node-positive, early-stage breast cancer at high risk of recurrence. In combination with an aromatase inhibitor as the initial endocrine-based therapy for adults with HR+/HER2- advanced or metastatic breast cancer. In combination with fulvestrant for adults with HR+/HER2- advanced or metastatic breast cancer that has progressed after prior endocrine therapy. As monotherapy for adults with HR+/HER2- advanced or metastatic breast cancer that has progressed following endocrine therapy and prior chemotherapy in the metastatic setting. Learn more about VERZENIO projected market size for breast cancer @ VERZENIO Market Potential HR+/HER2- breast cancer is the most common subtype of breast cancer, defined by the presence of estrogen and progesterone hormone receptors but lacking HER2 overexpression. This form of breast cancer generally has a favorable prognosis and is primarily managed with hormone therapy to suppress hormone-driven tumor growth. According to DelveInsight's estimates, around 211,000 new cases of HR+/HER2− breast cancer were reported in the US in 2024. Over the past decade, endocrine therapy has remained the cornerstone of treatment, including for cases with visceral involvement. The current preferred approach involves combining endocrine therapy—using aromatase inhibitors or fulvestrant—with CDK4/6 inhibitors. The approval of CDK4/6 inhibitors has significantly transformed the treatment landscape for HR+/HER2− breast cancer. Currently, five selective CDK4/6 inhibitors— ENHERTU, DATROWAY, IBRANCE, KISQALI, and VERZENIO—are used in combination with endocrine therapy. In November 2023, the FDA approved TRUQAP (capivasertib) in combination with FASLODEX for patients with advanced HR+/HER2− breast cancer harboring specific biomarker alterations (PIK3CA, AKT1, or PTEN). The NCCN Guidelines have designated KISQALI as the only Category 1 Preferred CDK4/6 inhibitor for first-line treatment in combination with an aromatase inhibitor, strengthening its position in the U.S. market. This led to KISQALI recovering its lost market share, with its U.S. revenue contribution rebounding to 50%, following declines to 46% in 2020, 36% in 2021, and 38% in 2022. In January 2025, the FDA approved DATROWAY for patients with unresectable or metastatic HR+/HER2- breast cancer (IHC 0, IHC 1+, or IHC 2+/ISH-) who had previously received endocrine-based therapy and chemotherapy. Additionally, ENHERTU was approved for patients with unresectable or metastatic HR+, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer that had progressed after at least one prior endocrine therapy in the metastatic setting. Also, in January 2025, Roche reported positive topline results from its Phase III INAVO120 trial, assessing ITOVEBI in combination with IBRANCE and fulvestrant for patients with PIK3CA-mutated HR+/HER2−, endocrine-resistant, locally advanced, or metastatic breast cancer. Among the seven major markets, the US accounted for the largest market share in HR+/HER2− breast cancer, generating USD 7.5 billion in revenue in 2023. The market is expected to experience substantial growth from 2025 to 2034, driven by the introduction of novel therapeutic options. Discover more about the breast cancer market in detail @ Metastatic HR+/HER2- Breast Cancer Market Report Emerging Competitors of VERZENIO Some of the competing emerging key players in HR+/HER2- breast cancer market are, Merck (KEYTRUDA), Arvinas (ARV-471 (vepdegestrant)), Olema Pharmaceuticals (OP1250 (palazestrant)), Celcuity (Gedatolisib), Roche (Giredestrant (RG6171, GDC-9545); Inavolisib), AstraZeneca and Daiichi Sankyo (Datopotamab Deruxtecan (Dato-DXd)), AstraZeneca (Camizestrant (AZD9833); Capivasertib), Eli Lilly (LY3484356/Imlunestrant), Sermonix Pharmaceuticals (Lasofoxifene), Veru Pharma (Enobosarm), DualityBio/BioNtech (DB-1303), Evgen Pharma (SFX-01), Carrick Therapeutics (Samuraciclib (CT-7001)), EQRx/G1 Therapeutics (Lerociclib), Immutep (Eftilagimod Alpha (LAG-3lg/IMP321)), and others. To know more about the number of competing drugs in development, visit @ VERZENIO Market Positioning Compared to Other Drugs Key Milestones of VERZENIO In 2024, Phase III trials did not meet primary endpoints or were terminated for futility. Negative Phase III CYCLONE-2 results, in which VERZENIO added to abiraterone did not meet the primary endpoint of improved radiographic progression-free survival (rPFS) in men with metastatic castration-resistant prostate cancer (mCRPC). In December 2023, Eli Lilly and Company presented results from the MONARCH 3 clinical trial at the 2023 San Antonio Breast Cancer Symposium (SABCS). Results from MONARCH 3 show a numerical improvement in overall survival (OS) of 13.1 months for women with HR+, HER2- metastatic breast cancer treated with VERZENIO plus an aromatase inhibitor in the intent-to-treat population and 14.9 months for women with visceral disease. In March 2023, the US FDA approved an expanded indication for VERZENIO in combination with endocrine therapy for the adjuvant treatment of adult patients with HR+/HER2−, node-positive, early breast cancer (EBC) at a high risk of recurrence. This expanded adjuvant indication removes the Ki-67 score requirement for patient selection. In February 2022, the CHMP adopted a positive opinion recommending a change to the terms of the marketing authorization for the medicinal product VERZENIO. VERZENIO, in combination with endocrine therapy, is indicated for the adjuvant treatment of adult patients with HR+/HER2− negative, node-positive early breast cancer at high risk of recurrence. In October 2021, the US FDA approved VERZENIO, in combination with endocrine therapy (tamoxifen or an aromatase inhibitor), for the adjuvant treatment of adult patients with HR+/HER2−, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score of ≥20% as determined by an FDA-approved test. Ki-67 is a marker of cellular proliferation. In September 2018, VERZENIO was approved in Europe for treating advanced HR+ breast cancer in women if the cancer has already spread to other parts of the body or is locally advanced. In September 2018, VERZENIO was approved for the treatment of patients with HR+/HER2− unresectable or recurrent breast cancer in combination with fulvestrant or an aromatase inhibitor (AI) in Japan. In February 2018, the US FDA approved VERZENIO in combination with an aromatase inhibitor (AI) as initial endocrine-based therapy for the treatment of postmenopausal women with HR+/HER2− advanced or metastatic breast cancer In September 2017, the US FDA approved VERZENIO in combination with an endocrine therapy to treat adult patients who have HR+/HER2− advanced or metastatic breast cancer that has progressed after taking therapy that alters a patient's hormones (endocrine therapy). In October 2015, the US FDA granted Breakthrough Therapy Designation to abemaciclib for patients with refractory hormone-receptor-positive (HR+) advanced or metastatic breast cancer Discover how VERZENIO is shaping the breast cancer treatment landscape @ VERZENIO Breast Cancer VERZENIO Market Dynamics The oral administration of VERZENIO enhances patient convenience, while its expanded approval for the adjuvant treatment of adult patients with HR+/HER2- early breast cancer highlights its role as a differentiated CDK4/6 inhibitor in reducing the risk of recurrence. The rising prevalence of HR+/HER2- breast cancer is driving market demand for effective treatments like VERZENIO. Additionally, its demonstrated efficacy in combination with endocrine therapy and its ability to penetrate the central nervous system further strengthen its market position. Favorable reimbursement policies and increasing awareness among healthcare providers also contribute to its adoption. However, its adoption may be hindered by regulatory hurdles and potential side effects, including severe or life-threatening lung inflammation and serious liver problems. High treatment costs and access disparities in certain regions could also limit market penetration. Competition from other CDK4/6 inhibitors such as IBRANCE and KISQALI poses a challenge, along with concerns over long-term safety data. Additionally, the Phase III CYCLONE-2 trial failed to meet primary endpoints in mCRPC, which may impact its broader clinical prospects and investor confidence. Dive deeper to get more insight into VERZENIO's strengths & weaknesses relative to competitors @ VERZENIO Market Drug Report Table of Contents Related Reports CDK4/6 Inhibitor Market CDK4/6 Inhibitor Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key CDK4/6 inhibitor companies including Pfizer, Prelude Therapeutics, G1 Therapeutics, Pepper Bio, among others. Metastatic HR+/HER2− Breast Cancer Market Metastatic HR+/HER2− Breast Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key metastatic HR+/HER2− breast cancer companies including Pfizer, Novartis, Stemline Therapeutics, Olema Pharmaceuticals, Arvinas, Immutep, AstraZeneca, Roche, Genentech, Evexta Bio, EQRx, Sermonix Pharmaceuticals, Celcuity, Veru Pharma, Evgen Pharma, Eli Lilly, Biotheryx, among others. HR+/HER2− Breast Cancer Pipeline HR+/HER2− Breast Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key HR+/HER2− breast cancer companies, including Regor Therapeuics, Seagen Inc., CytomX Therapeutics, Taizhou EOC Pharma, Chia Tai Tianqing Pharmaceutical Group, AstraZeneca, Daiichi Sankyo, Inc., Tyme, Inc., Seagen Inc., Context Therapeutics, Eisai Inc., Shanghai Hengrui Pharmaceutical Co., Ltd., Jiangsu Simcere Pharmaceutical Co., Kind Pharmaceuticals, Merus N.V., Atossa Therapeutics, Roche, among others. Breast Cancer Market Breast Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key breast cancer companies, including Veru, Sanofi, Roche, AstraZeneca, Eli Lilly, EQRx, Gilead, Sermonix Pharmaceuticals, Evgen Pharma, Tyme, Genentech, Daiichi Sankyo, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Drug ApprovalClinical ResultBreakthrough TherapyASCO

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

30 Jan 2025

·pmlive.com

Roche shares positive overall survival results for Itovebi in advanced breast cancer

Roche has shared positive top-line overall survival results from a late-stage study of its oral PI3K inhibitor Itovebi (inavolisib) in a subset of advanced breast cancer patients. The phase INAVO120 trial has been evaluating the drug in combination with Pfizer’s CDK4/6 inhibitor Ibrance (palbociclib) and AstraZeneca’s hormone therapy Faslodex (fulvestrant) in patient with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, endocrine-resistant, locally advanced or metastatic breast cancer. Approximately 56,800 new breast cancer cases are diagnosed in the UK every year, and HR-positive disease is the most prevalent subtype. The PI3K signalling pathway is commonly dysregulated in HR-positive breast cancer, often due to activating PIK3CA mutations, which are considered to be a potential mechanism of resistance to standard-of-care hormone therapy in combination with CDK4/6 inhibitors. Results from INAVO120 previously reported by Roche showed that the Itovebi-based regimen reduced the risk of disease worsening or death by 57% compared with Ibrance and Faslodex alone in the first-line setting. The company has now announced that the trial met its secondary endpoint, with the triplet therapy demonstrating a statistically significant and clinically meaningful overall benefit versus Ibrance and Faslodex alone. Levi Garraway, Roche’s chief medical officer and head of global product development, said: “The INAVO120 overall survival results show that the Itovebi-based regimen not only delayed disease progression, but also helped people with advanced HR-positive, PIK3CA-mutated breast cancer live longer. “These findings underscore our ambition to improve survival rates for people with breast cancer. The Itovebi-based regimen has the potential to become the new standard of care for these patients.” The announcement comes just three months after the US Food and Drug Administration approved the Itovebi regimen based on results from INAVO120. Data from the trial is being reviewed by other global health authorities, including the European Medicines Agency. Garraway said at the time of the October authorisation: “Despite the high prevalence of PIK3CA mutations in this setting, treatment options have thus far remained limited, which makes [this] approval all the more significant.” Itovebi is also currently being evaluated in various combinations across three additional late-stage studies in PIK3CA-mutated locally advanced or metastatic breast cancer.

Clinical ResultPhase 3Phase 2

100 Deals associated with Inavolisib

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Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Breast Cancer	Canada	Hoffmann-La Roche Ltd.	01 Feb 2025
PIK3CA mutation/HR-positive/HER2-negative Breast Cancer	United States	Genentech, Inc.	10 Oct 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
PIK3CA mutant Breast Cancer	Phase 3	Ukraine	Hoffmann-La Roche, Inc.	29 Jan 2020
PIK3CA mutant Breast Cancer	Phase 3	Argentina	Hoffmann-La Roche, Inc.	29 Jan 2020
PIK3CA mutant Breast Cancer	Phase 3	Australia	Hoffmann-La Roche, Inc.	29 Jan 2020
PIK3CA mutant Breast Cancer	Phase 3	United Kingdom	Hoffmann-La Roche, Inc.	29 Jan 2020
PIK3CA mutant Breast Cancer	Phase 3	Taiwan Province	Hoffmann-La Roche, Inc.	29 Jan 2020
PIK3CA mutant Breast Cancer	Phase 3	Brazil	Hoffmann-La Roche, Inc.	29 Jan 2020
PIK3CA mutant Breast Cancer	Phase 3	United States	Hoffmann-La Roche, Inc.	29 Jan 2020
PIK3CA mutant Breast Cancer	Phase 3	Russia	Hoffmann-La Roche, Inc.	29 Jan 2020
PIK3CA mutant Breast Cancer	Phase 3	Turkey	Hoffmann-La Roche, Inc.	29 Jan 2020
PIK3CA mutated/HER2 Positive Breast Cancer	Phase 3	United States	Roche Holding AG	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04191499 (INAVO120, Pubmed \| N Engl J Med \| NEWS) Manual	Phase 3	PIK3CA mutation/HR-positive/HER2-negative Breast Cancer First line \| \|	325	Inavolisib plus palbociclib-fulvestrant	(zwsxpjwosj) = kdufmmntpl vjmevkwgnk (mlzppctfru, 11.3 - 20.5) View more	Positive	31 Oct 2024
				Placebo plus palbociclib-fulvestrant	(zwsxpjwosj) = pbqhtgyrcl vjmevkwgnk (mlzppctfru, 5.6 - 9.3) View more
NCT04191499 (INAVO120, FDA) Manual	Phase 2/3	PIK3CA mutation/HR-positive/HER2-negative Breast Cancer \| \|	325	Inavolisib 9 mg + Palbociclib + Fulvestrant	(xexnwqxhda) = mvrvzenjon hybtcsemgq (nczikzmimw, 11.3 - 20.5) View more	Positive	10 Oct 2024
				Placebo + Palbociclib + Fulvestrant	(xexnwqxhda) = fvhgjabqen hybtcsemgq (nczikzmimw, 5.6 - 9.3) View more
NCT04191499 (INAVO120, CTgov)	Phase 2/3	PIK3CA mutant Breast Cancer	325	fulvestrant+palbociclib+inavolisib (Inavo+Palbo+Fulv)	(diijarkpjc) = kobkgkmxwn wyvwyfceuz (mkivhqavdn, sdmsihbhvh - uupqtgxpml) View more	-	09 Oct 2024
				placebo+fulvestrant+palbociclib (Pbo+Palbo+Fulv)	(diijarkpjc) = tlcpaqjthe wyvwyfceuz (mkivhqavdn, odlaknascn - hgwzkzqfpu) View more
NCT04551521 (CRAFT, ESMO2024) Manual	Phase 2	Neoplasms	25	Inavolisib 9 mg q.d.	(yckxahzblk) = uwxtklylfp rrrzbowfks (xcnwfsqjmg ) View more	Positive	15 Sep 2024
NCT03006172 (Pubmed \| J Clin Oncol) Manual	Phase 1	PIK3CA mutation/HR-positive/HER2-negative Breast Cancer \| \|	53	Inavolisib + Palbociclib + Letrozole	(oftuljktyb) = occurred in all patients; the most frequent were stomatitis, hyperglycemia, and diarrhea sfbwkrtyfa (nakvpbxvcm )	Positive	05 Sep 2024
				Inavolisib + Palbociclib + Fulvestrant
NCT04191499 (INAVO120, ASCO2024) Manual	Phase 3	PIK3CA mutation/HR-positive/HER2-negative Breast Cancer \| PIK3CA positive/ER positive/HER2 negative/breast cancer First line	325	Inavolisib+Palbociclib+Fulvestrant	(lvypuzqtzq) = vzsrcizjml uylhjgzydv (zntxzkexbp, 18.6–NE) View more	Positive	24 May 2024
				Placebo+Palbociclib+Fulvestrant	(lvypuzqtzq) = npccelelwt uylhjgzydv (zntxzkexbp, 13.5–22.3) View more
NCT04191499 (INAVO120, Corporate Publications) Manual	Phase 3	PIK3CA mutation/HR-positive/HER2-negative Breast Cancer First line \| \|	325	Inavolisib+Palbociclib+Fulvestrant	(oykydfuugs) = The study met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant and clinically meaningful improvement compared to palbociclib and fulvestrant alone. wtqtgxbetj (wpenmuvudf ) Met	Positive	04 Dec 2023
				Placebo+Palbociclib+Fulvestrant
NCT03006172 (ASCO2022) Manual	Phase 1	PIK3CA mutation/HR-positive/HER2-negative Breast Cancer PIK3CA Mutation \| HR Positive \| HER2 Negative	57	inavolisib	(vxmkqdxeck) = 2 (4%) discontinued treatment due to an AE (1 related G2 diarrhea, 1 unrelated G3 cerebrovascular disorder). dqeldvtybf (mkjmiycjbe ) View more	Positive	02 Jun 2022
				palbociclib+letrozole+inavolisib
NCT03006172 (GO39374, SABCS2022)	Phase 1	PIK3CA H1047R mutant Solid Tumors \| PIK3CA mutant Breast Cancer PIK3CA-	55	Inavolisib 9 mg + Fulvestrant 500 mg	aubxfuusvq(bzaomcfyxj) = xckfrzdzxc vkshpmrecv (hcfkbjxhcy ) View more	Positive	15 Feb 2022
NCT03006172 (AACR2021) Manual	Phase 1	PIK3CA mutation/HR-positive/HER2-negative Breast Cancer PIK3CA Mutation \| HR Positive \| HER2 Negative	28	palbociclib+fulvestrant+GDC-0077 (Arm E)	(xjwjvcknyv) = rsxxzhhtps yzybhpmjpj (ipegzoawzj ) View more	Positive	15 Feb 2021
				palbociclib+fulvestrant+Metformin+GDC-0077 (Arm F)	(xjwjvcknyv) = ktzjcgofyr yzybhpmjpj (ipegzoawzj ) View more

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