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 Apr 2025

Sponsor / Collaborator

Hubei Cancer Hospital

100 Clinical Results associated with Palbociclib

100 Translational Medicine associated with Palbociclib

100 Patents (Medical) associated with Palbociclib

3,441

Literatures (Medical) associated with Palbociclib

01 Jun 2025·Clinical Genitourinary Cancer

CDK4/6 Inhibition With Abemaciclib in Patients With Previously Treated Advanced Renal Cell Carcinoma

Article

Author: Xu, Wenxin ; Kaelin, William G ; McGregor, Bradley A ; Choueiri, Toni K ; McDermott, David ; Xie, Wanling ; Berg, Stephanie A ; Signoretti, Sabina ; Viswanathan, Srinivas R

BACKGROUND:

Preclincal data provide a rationale for cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitors alone and in combination with HIF-2α inhibitors in treatment of clear cell renal cell carcinoma (ccRCC), with randomized phase 2 clinical trials currently open exploring the combination of palbociclib with belzutifan vs belzutifan in treatment resistant ccRCC (NCT05468697). However, single agent activity for CDK4/6 inhibitors in ccRCC has not been reported. In this multi-center phase 1b clinical trial (NCT04627064), we investigated the safety and efficacy of monotherapy with abemaciclib, an oral CDK4/6 inhibitor in patients with advanced pretreated RCC.

METHODS:

Adult patients with advanced RCC with a clear cell component and ECOG status of ≤ 2 progressing after at least 1 prior regimen including immunotherapy and a VEGFR TKI received abemaciclib 200 mg twice daily in 4-week cycles until progression or unacceptable toxicity. The primary objective was to evaluate the objective response rate (ORR) of abemaciclib with a secondary endpoint of safety. First imaging was performed after 8 weeks or 2 cycles. Response was assessed per RECIST 1.1 and toxicity graded per CTCAE v5.0.

RESULTS:

Eleven patients were enrolled between December 31, 2020 and October 03, 2023. Median age was 62 years (range 54-68); 73% (n = 8) had IMDC intermediate risk disease and 1 patient had translocation RCC with a clear cell component. Median number of prior therapies was 4 (range 1-9). ORR was 0% (0/11; 8 progressive disease, 1 stable disease stopping for clinical progression, 2 not evaluable with clinical progression). About 27% (n = 3) experienced grade ≥3 treatment-related adverse events (diarrhea n = 1, nausea n = 1, neutropenia n = 1).

CONCLUSION:

In patients with heavily pretreated metastatic RCC, abemaciclib monotherapy had no clinically meaningful activity without new toxicity signals. This data will offer important insight into interpretation of results for ongoing trials exploring CDK4/6 inhibition in combination with HIF-2α inhibitors and immunotherapy.

01 Jun 2025·BREAST

Real-world palbociclib dose modifications and clinical outcomes in patients with HR+/HER2− metastatic breast cancer: A Flatiron Health database analysis

Article

Author: Layman, Rachel M ; Liu, Xianchen ; Li, Benjamin ; McRoy, Lynn ; Brufsky, Adam

PURPOSE:

To examine the associations of palbociclib dose modifications with clinical outcomes of patients with HR+/HER2- metastatic breast cancer (MBC) treated with first-line (1L) palbociclib + aromatase inhibitor (AI) in routine practice.

METHODS:

Using the Flatiron Health Analytic Database, we conducted a retrospective analysis of HR+/HER2- MBC patients who started 1L palbociclib + AI February 2015-March 2020. Kaplan-Meier analyses were used to estimate treatment duration, real-world progression-free survival (rwPFS), and overall survival (OS) by palbociclib dose adjustments (any change in palbociclib daily dose while on treatment) and dose reductions (starting dose <125 mg/day or dose reduced while on treatment). Cox proportional hazard regression models were performed to compute unadjusted/adjusted hazard ratios (HRs).

RESULTS:

Of 1302 patients with documented starting dose, 524 (40.2 %) had palbociclib dose adjustments; 778 (59.8 %) had none. Median treatment duration was significantly longer in patients with dose adjustments versus those with none (27.4 vs 21.4 months; adjusted HR = 0.80 [95 % CI, 0.69-0.93]; P = 0.004). Patients with and without dose adjustments showed similar median rwPFS (20.5 vs 19.6 months; adjusted HR = 0.89 [95 % CI, 0.76-1.04]; P = 0.133). Median OS was significantly prolonged in patients with versus without dose adjustments (57.8 vs 51.4 months; adjusted HR = 0.73 [95 % CI, 0.59-0.89]; P = 0.002). Similar findings were observed in patients with and without dose reductions.

CONCLUSIONS:

In this real-world study, rwPFS in HR+/HER2- MBC patients was maintained irrespective of dose adjustments. However, dose adjustments were associated with extended treatment duration and OS.

CLINICAL TRIAL REGISTRATION:

NCT05361655 (ClinicalTrials.gov).

01 May 2025·INTERNATIONAL JOURNAL OF CANCER

Head‐to‐head comparison of palbociclib and ribociclib in first‐line treatment of HR‐positive/HER2‐negative metastatic breast cancer with real‐world data from the OPAL registry

Article

Author: Decker, Thomas ; Harbeck, Nadia ; Fricker, Roland ; Nusch, Arnd ; Zahn, Mark‐Oliver ; Wöckel, Achim ; Hagen, Volker ; Thill, Marc ; Welt, Anja ; Stickeler, Elmar ; Kaltenecker, Gabriele ; Dille, Stephanie ; Engelken, Kathrin ; Ringwald, Kai ; Zaiss, Matthias ; Kruggel, Lisa ; Gratzke, Katja ; Schulz, Holger ; Jänicke, Martina

Abstract:

Cyclin‐dependent kinase 4/6 inhibitors (CDKIs) in combination with endocrine therapy (ET) are the standard‐of‐care in the first‐line treatment of HR‐positive, HER2‐negative metastatic breast cancer. In the absence of direct head‐to‐head trials comparing the efficacy and safety of the different CDKIs, the individual choice of treatment in everyday practice is complex. Inverse probability of treatment weighting was used to emulate a head‐to‐head comparison of palbociclib +ET (PALBO) and ribociclib +ET (RIBO) in patients recruited into the prospective, observational, multicenter registry platform OPAL (NCT03417115). Progression‐free survival (PFS), overall survival (OS) and quality of life surveys were analyzed, also for subgroups stratified by treatment‐free interval (TFI). A total of 623 patients with HR‐positive, HER2‐negative metastatic breast cancer received PALBO (n = 388) or RIBO (n = 235) in their first line of treatment. No difference between PALBO and RIBO was found for PFS (median 26.7 months [23.6, 30.7] vs. 27.0 months [21.1, 30.4], HR 1.01 [0.80, 1.27]) and OS (median 42.4 months [38.8, 50.3] vs. 49.3 months [36.9, NA], HR 0.96 [0.71, 1.28]). There was a trend for longer PFS and OS in patients with TFI <12 months receiving RIBO. Patients reported comparable side effects for both CDKIs. This head‐to‐head comparison revealed no difference in PFS and OS between PALBO and RIBO, however, a trend to longer PFS and OS with RIBO was observed in the subgroup of patients with TFI <12 months. Side effects experienced with PALBO and RIBO highlight the important toxicities to be addressed during treatment decision.

410

News (Medical) associated with Palbociclib

11 Apr 2025

·www.pharmaceutical-technology.com

AstraZeneca’s oral breast cancer drug Truqap greenlit for NHS use

Truqap has been approved patients with the most common type of breast cancer on the NHS. Image credit: Shutterstock/Yakobckuk Viacheslav. AstraZeneca’s Truqap (capivasertib) has been approved for use by the National Health Service (NHS) in England and Wales, providing a new targeted therapy option that significantly increases progression-free survival (PFS) in breast cancer patients. National Institute for Health and Care Excellence (NICE), the spending watchdog for the NHS, has recommended the drug to be used in combination with AstraZeneca’s already-marketed breast cancer drug Faslodex (fulvestrant). Adults with hormone receptor (HR)-positive HER2-negative breast cancer that has one or more PIK3CA, AKT1 or PTEN gene alterations and is locally advanced or metastatic are eligible for the therapy. NICE estimates around 1,100 patients will be able to take the new twice-a-day tablet, with London’s Institute of Cancer Research (ICR) forecasting that the combo therapy will eventually benefit around 3,000 a year. Truqap will likely become a key revenue driver for AstraZeneca. The drug is forecast to reach blockbuster status by 2027, whilst 2031 global sales are expected to hit nearly $2bn, as per GlobalData’s Pharma Intelligence Centre. As well as the UK, Truqap is also approved in the US , the European Union (EU), and Japan, amongst others. GlobalData is the parent company of Pharmaceutical Technology . The HR-positive HER2-negative breast cancer drug market also includes Pfizer’s Ibrance (palbociclib), Eli Lilly’s Verzenio (abemaciclib), and Novartis’ Kisqali (ribociclib). Breast cancer is the most common cancer in the UK, affecting one in seven women. Treatments have progressed over the past few decades, meaning 75% of patients survive for 10 years or more after diagnosis. HR-positive HER2-negative breast cancer is the most common type of breast cancer. Results from the Phase III CAPItello-291 trial (NCT04305496) showed that Truqap doubled the time it took for cancer to progress in 708 women with HR-positive HER2-negative breast cancer patients. The median PFS was 7.3 months in those who received Truqap and Faslodex, compared to 3.1 months in patients who received hormone therapy alone. The NHS availability of Truqap is a ‘triumph’ according to Professor Kristian Helin, chief executive of ICR. “This announcement is a triumph that will improve treatment for these patients with the most common type of advanced breast cancer. Around half of patients with this kind of breast cancer have mutations in one or more of the genes and for these patients, Truqap can halt disease progression. I’m delighted that access to the drug is being expanded to NHS patients in England and Wales who are in desperate need of better options,” Professor Helin commented. Patients with advanced HR-positive HER-2 negative breast cancer in the UK are currently offered the option to continue Faslodex or chemotherapy. Faslodex on its own is often ineffective and chemotherapy carries side effects, the ICR stated. “People with advanced breast cancer would value treatments like [Truqap] that can be given when limited options exist and because it may delay the need for chemotherapy and its associated side-effects,” NICE’s director of medicines evaluation Helen Knight said. Truqap works by inhibiting all three isoforms of the AKT protein. AKT kinases enable cancer cell growth and multiplication. NICE said that whilst there have been no clinical trials directly comparing the new combo therapy to existing approved regimens, indirect comparisons suggest non-inferiority. The recommendation by NICE represents a U-turn after the agency initially rejected the therapy due to uncertainties over its cost-effectiveness. Breast Cancer Now’s chief executive Claire Rowney said this meant “patients faced unnecessary delays in accessing” the treatment. She added that “NHS England must now put in place prompt genetic testing to ensure those eligible to receive [Truqap] without further delay.”

Clinical ResultPhase 3Drug Approval

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

27 Feb 2025

·www.echemi.com

AstraZeneca's Next-Gen Oral SERD Shows Promising Results in Breast Cancer Trial

On February 26, 2025, AstraZeneca announced positive mid-term results from the Phase III SERENA-6 trial for its oral selective estrogen receptor degrader (SERD) camizestrant. The study demonstrated statistically and clinically significant improvements in progression-free survival (PFS) when combined with CDK4/6 inhibitors such as palbociclib, ribociclib, or abemaciclib. This marks camizestrant as the first and only oral SERD proven to provide first-line treatment benefits when used with approved CDK4/6 inhibitors. The SERENA-6 trial assessed the efficacy and safety of switching to camizestrant in patients with hormone receptor-positive (HR+), HER2-negative advanced breast cancer harboring ESR1 mutations. The study compared the camizestrant combination therapy to the standard care of continuing with aromatase inhibitors like anastrozole or letrozole alongside CDK4/6 inhibitors. While key secondary endpoints such as PFS2 and overall survival (OS) remain immature at this stage, there is a noted trend towards improved PFS2 in the camizestrant group. The trial will continue as planned to further evaluate these critical secondary endpoints. Notably, SERENA-6 is the first global, double-blind Phase III trial utilizing circulating tumor DNA (ctDNA) to guide the detection of endocrine resistance. This innovative approach allows for early identification of endocrine resistance signs and the emergence of ESR1 mutations during routine tumor scans. Upon detection of ESR1 mutations without disease progression, patients transitioned from aromatase inhibitor therapy to camizestrant while maintaining treatment with the same CDK4/6 inhibitor. François-Clément Bidard, a professor of medical oncology at Université Versailles-Saint-Quentin, who is also the principal investigator of the trial, stated, “Patients urgently need new therapies to delay disease progression during first-line endocrine therapy. The SERENA-6 trial shows that transitioning to camizestrant after the emergence of ESR1 mutations can delay disease progression and extend the benefits of first-line treatment, representing a significant step forward for patients and a potential shift in clinical practice.” Susan Galbraith, Executive Vice President of Oncology Research and Development at AstraZeneca, noted that these impressive results indicate camizestrant’s versatility in combination with approved CDK4/6 inhibitors, offering a promising new treatment option for one-third of HR+ HER2-negative advanced breast cancer patients who develop ESR1 mutations while receiving aromatase inhibitors with CDK4/6 inhibitors. This pivotal outcome brings AstraZeneca closer to establishing camizestrant as a new standard of care, aiming to transform treatment paradigms in HR+ breast cancer. Globally, approximately 200,000 HR+ breast cancer patients receive first-line drug treatment, typically involving endocrine therapy targeting estrogen receptor-driven disease, often in conjunction with CDK4/6 inhibitors. However, many advanced patients develop resistance to these treatments. ESR1 mutations are key drivers of this resistance and are widely tested in clinical practice, becoming more prevalent as the disease progresses and associated with poor outcomes. About 30% of endocrine-sensitive HR+ patients experience ESR1 mutations during first-line treatment without disease progression.

Phase 3Clinical Result

100 Deals associated with Palbociclib

External Link

KEGG	Wiki	ATC	Drug Bank
D10372	Palbociclib	L01XE33	DB09073

R&D Status

Approved

10 top approved records.

to view more data

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

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Human Papillomavirus-Related Squamous Cell Carcinoma	Phase 3	United States	Pfizer Inc.	06 Apr 2022
Squamous Cell Carcinoma of Head and Neck	Phase 3	United States	Pfizer Inc.	06 Apr 2022
Squamous cell carcinoma of head and neck metastatic	Phase 3	United States	Pfizer Inc.	06 Apr 2022
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	Austria	Pfizer Inc.	27 Aug 2019
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	France	Pfizer Inc.	27 Aug 2019
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	Hungary	Pfizer Inc.	27 Aug 2019
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	Italy	Pfizer Inc.	27 Aug 2019
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	Spain	Pfizer Inc.	27 Aug 2019
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	Switzerland	Pfizer Inc.	27 Aug 2019
HER2-negative breast cancer	Phase 3	Japan	Pfizer Inc.	16 Jul 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05361655 (Pubmed \| Breast)	Not Applicable	Metastatic breast cancer First line	1,302	Palbociclib dose adjustments	iugllstxqv(khnlewkxbz) = xiiqvouicm zammlgzubm (wxtficzvyo ) View more	Positive	01 Jun 2025
				No palbociclib dose adjustments	iugllstxqv(khnlewkxbz) = sxktxfowlr zammlgzubm (wxtficzvyo ) View more
NCT06086340 (Pubmed \| Cancer Med)	Not Applicable	Metastatic breast cancer \| Hormone receptor positive HER2 negative breast cancer HR+ \| HER2-	779	Palbociclib + Aromatase Inhibitor	plfeaxdjmu(sqdefqbnzu) = oeohugvqyl mqrbjtokwl (krzcnxmyjt )	Positive	01 Apr 2025
				Aromatase Inhibitor Alone	plfeaxdjmu(sqdefqbnzu) = hauorieulv mqrbjtokwl (krzcnxmyjt )
NCT04494958 (PALBOBIN, CTgov)	Phase 1/2	Advanced Triple-Negative Breast Carcinoma	24	Palbociclib+Binimetinib	vpnjqpodzw = pvbomqfczj iaselfdqfk (nryjtwikau, xmhbhitwyq - aylndbswjw) View more	-	24 Mar 2025
NCT03774472 (CTgov)	Phase 1/2	ER-positive/HER2-negative Breast Cancer \| Metastatic breast cancer	15	HCQ (HCQ at 400 mg)	oisghrxoyl = irwzvegpby fvrbvfetpo (hccsjrwesk, pespljzyru - mcgxskyhcu) View more	-	17 Feb 2025
				HCQ (HCQ at 600 mg)	oisghrxoyl = kfkqlbadak fvrbvfetpo (hccsjrwesk, wgofzlcryt - alnyhwqldq) View more
Pubmed \| Future Oncol	Not Applicable	Metastatic breast cancer	-	Palbociclib-fulvestrant	ytffsblpxb(wqswjmkjir) = vnzhqhjako ifzeeczkwy (dfqkrulvld, 15.2 - 23.6)	-	02 Jan 2025
NCT04256941 (CTgov)	Phase 2	Metastatic breast cancer	4	Fulvestrant (Fulvestrant)	eyezpwezqx(aduuovyluy) = ggutupascz qstgvwgark (lizgwvvdjc, berjvhsbey - nznsxvkusd) View more	-	27 Dec 2024
				fulvestrant+ribociclib (Kisqali)+abemaciclib (verzenio)+palbociclib (Ibrance) (Continuing AI After Randomization)	eyezpwezqx(aduuovyluy) = jbzxremahr qstgvwgark (lizgwvvdjc, gmffzxxiqu - jryvgumgus) 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	gxyjpadacv(ifxxmrgpth): 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)	wixwxtcgja = ajdyvggamk edxzuakxlz (iqaxrqwwzv, aeravdowqd - lunhdzusbk) View more	-	13 Dec 2024
				Trastuzumab+Letrozole+palbociclib+pertuzumab (Palbociclib Plus Letrozole Plus Trastuzumab and Pertuzumab)	wixwxtcgja = kdkrpaiben edxzuakxlz (iqaxrqwwzv, aovxfsgnlz - pmswzdpzxz) 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	avviqpenjy(ctcpasthhv) = ymvqooowxk bjbhsxejgs (xcrbckqhkl, 32.4 - 60.9) View more	Positive	12 Dec 2024
				Anti-HER2 therapy + endocrine therapy	avviqpenjy(ctcpasthhv) = vloqidztex bjbhsxejgs (xcrbckqhkl, 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	dqvaglvwyc = jtlxtyxcvg oosuvoexcx (nziiupehnk, tltevzcinc - hqegwwvuxa) View more	-	10 Dec 2024

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