A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO COMPARE THE PHARMACOKINETICS OF ATIRMOCICLIB IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITH NORMAL HEPATIC FUNCTION

The purpose of this study to understand how the study medicine atirmociclib behaves in the body and how safe it is for people with different levels of liver health.
The study is seeking participants who are:
* Aged 18 years or older
* Have a BMI of 17.5 to 40 kg/m2, and body weight more than 50 kg.
* Have normal liver function or have stable mild, moderate, or severe liver disease
Participants will receive study medicine by mouth. Blood samples will be collected to see how much of the medicine is in the body over time. This will help understand whether liver disease changes how the medicine is handled.
Participants will be in the study for about 9 weeks. Those with normal liver function will stay in the clinic for about 7 days. People with liver disease will stay for about 9 days. After leaving the clinic, people may be contacted for follow-up. This may be done by phone or through a clinic visit.

Start Date29 Jun 2026

Sponsor / Collaborator

Pfizer Inc.

NCT07427394

/ RecruitingPhase 2

A Phase IIa, Open-label Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of Camizestrant in Combination With Atirmociclib in Participants With ER-positive, HER2-negative Advanced Breast Cancer (SERENA-1b)

A study to investigate camizestrant in combination with atirmociclib in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with a cyclin dependent kinase 4/6 (CDK4/6) inhibitor.

Start Date06 May 2026

Sponsor / Collaborator

AstraZeneca PLC

NCT07215078

/ CompletedPhase 1

A PHASE 1, OPEN-LABEL, TWO-PERIOD, CROSS-OVER STUDY TO EVALUATE DOSE PROPORTIONALITY OF ATIRMOCICLIB (PF-07220060) PHARMACOKINETICS WHEN ADMINISTERED UNDER FED CONDITIONS TO HEALTHY PARTICIPANTS

The purpose of this clinical trial is to learn about the dose proportionality on the PK of the study medicine (called atirmociclib) when administered in the various doses range under the fed condition in healthy participants.
This study is seeking participants who are:
1. male and female aged 18 to 65 years are healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests
2. with BMI of 17.5-30.5 kg/m2; and a total body weight >50 kgs (110 lbs.).
All participants (72 total) in this study will receive atirmociclib at Dose (A), Dose (B), Dose (C), and Dose (D) oral dose in 1 of the 12 treatment sequences among 6 cohorts under fed conditions.
Atirmociclib will be given by mouth at the study research unit once single dose about 30 minutes after a moderate fat standard calorie meal.
Dose proportionality will be evaluated on the pharmacokinetics (PK), safety and tolerability of atirmociclib at Doses (A), (B), (C), and (D) oral dose under the fed condition.
Including the 28 days of screening window and the 35 days safety follow-up period, the total study duration for each participant can be up to 71 days, containing 2 periods (6 days for each period), minimum 7-day interval between two periods, and follow-up period 28 to 35 days from administration of the final dose of study intervention. During this time, they will undergo safety laboratory and serial blood PK samplings up to 120 hours after administration of atirmociclib to determine plasma concentrations of atirmociclib. Participants will be discharged from the research unit on Period 2 Day 6 following completion of all assessments.

Start Date08 Oct 2025

Sponsor / Collaborator

Pfizer Inc.

100 Clinical Results associated with Atirmociclib

100 Translational Medicine associated with Atirmociclib

100 Patents (Medical) associated with Atirmociclib

Literatures (Medical) associated with Atirmociclib

31 Dec 2026·JOURNAL OF ENZYME INHIBITION AND MEDICINAL CHEMISTRY

Identification of benzoxazine scaffold derivatives as novel CDK4 inhibitors for the treatment of cancer

Article

Author: Wei, Youyan ; Lin, Chao ; Zhang, Huateng ; Yang, Dan ; Li, Bo ; Sun, Shaofeng

Cyclin-dependent kinase 4, a pivotal regulator of cell cycle progression, is widely recognised as a therapeutic target for controlling tumour proliferation. Inspired by the reported CDK4 inhibitor PF-07220060, a series of novel benzoxazine derivatives were designed, synthesised, and evaluated for their biological activity. From this series, compound 8j emerged as the most potent anti-proliferative agent. Subsequent in vitro studies showed 8j effectively inhibits HCT116 cell proliferation, clonogenic survival, and migration. Mechanistic investigations revealed that 8j induces G1 phase cell cycle arrest and promotes apoptosis, which was corroborated by the observed concentration-dependent downregulation of key cell cycle regulators, including CDK4 and cyclin D1. Molecular docking and dynamics simulations substantiated the binding mode of 8jwithin the ATP-binding pocket of CDK4, revealing stable interactions characterised by key hydrogen bonds and hydrophobic contacts. Collectively, these results identify compound 8j as a promising lead candidate worthy of further structural optimisation and preclinical development.

01 Dec 2026·JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Development and ICH M10-compliant validation of an LC–MS/MS method for quantification of atirmociclib in mouse plasma and its application to preclinical pharmacokinetic studies

Article

Author: Sekar, Sasikumar ; Kalonia, Harikesh ; Gavali, Ashutosh ; Raje, Amol ; Kadam, Samadhan ; Jadhavar, Pradeep ; Nadawade, Vijay ; Gaur, Ashwani ; Patel, Urvesh ; Mohanty, Subhendu ; Samanta, Swapan ; Changappa, Kanagamakula

Atirmociclib is a selective cyclin-dependent kinase 4 (CDK4) inhibitor currently under clinical investigation for the treatment of advanced malignancies, particularly hormone receptor positive (HR+) or human epidermal growth factor receptor 2 negative (HER2-) breast cancer. Here, we report the first validated liquid chromatography tandem mass spectrometry (LC-MS/MS) bioanalytical method for the quantification of atirmociclib in mouse plasma, validated in compliance with international council for harmonisation-M10 (ICH-M10) guidelines. Sample preparation involved a rapid and straightforward protein precipitation approach using acetonitrile, yielding consistent recovery (>80%) across low to high concentration levels. Chromatographic separation was achieved on a Kinetex C18 column (50 mm length × 2.1 mm internal diameter, 5 μm particle size) using gradient elution with 5 mM ammonium acetate in water (mobile phase A) and 0.1% v/v formic acid in acetonitrile (mobile phase B). The analyte (atirmociclib) and internal standard (warfarin) were detected using Q1/Q3 (m/z) mass transitions 464.2/303.9 and 309.0/163.0 respectively. The method demonstrated excellent selectivity, accuracy, precision, and linearity over a concentration range of 1-1000 ng/mL. Additionally, reliable quantification was maintained for samples exceeding the upper limit of quantification following up to 10-fold dilution. All validation parameters, including stability in biological matrices and solution, met the predefined acceptance criteria. This sensitive, and reproducible method was successfully applied to support preclinical pharmacokinetic study of atirmociclib in mouse, providing a valuable analytical tool.

01 Dec 2026·JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Corrigendum to “Development and ICH M10-compliant validation of an LC–MS/MS method for quantification of Atirmociclib in mouse plasma and its application to preclinical pharmacokinetic studies” [J. Chromatogr. B 1284 (2026) 125271]

Author: Sekar, Sasikumar ; Kalonia, Harikesh ; Sundar, Lakshmi M ; Raje, Amol ; Jadhavar, Pradeep ; Gaur, Ashwani ; Nadawade, Vijay ; Patel, Urvesh ; Mohanty, Subhendu ; Gavali, Ashutosh ; Kadam, Samadhan ; Samanta, Swapan ; Changappa, Kanagamakula

News (Medical) associated with Atirmociclib

28 Sep 2026

·www.pfizer.com

Pfizer Advances Today’s Cancer Care and Tomorrow's Potential Breakthroughs at ESMO

Data across 45 abstracts will highlight new evidence for established medicines, including PADCEV and TALZENNA, and promising late-stage pipeline candidates such as atirmociclib and tivunatamig (PF’4404) NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) will present data from 45 company-sponsored, investigator-sponsored, and collaborative research abstracts at the European Society for Medical Oncology (ESMO) Congress, taking place October 23-27, 2026 in Madrid, Spain. The presentations include 11 oral presentations spanning Pfizer’s established medicines and late-stage pipeline across its disease areas of focus, including breast cancer, genitourinary cancers, and lung cancer. “At Pfizer Oncology, we're focused on improving outcomes for people living with cancer. That means continuing to raise the standard of care today while pursuing the breakthroughs that will shape the future of oncology. The data we're presenting at ESMO reflect that focus, strengthening the evidence behind medicines such as PADCEV and TALZENNA, while advancing promising investigational candidates including atirmociclib and tivunatamig. By building on our leadership in breast, genitourinary, and lung cancers, we're working to bring meaningful progress to patients today and for years to come.” - Jeff Legos, Chief Oncology Officer, Pfizer Key Highlights of Pfizer’s Presence at ESMO 2026 Guiding the Next Wave of Oncology Innovation Phase 2 randomized results from the FOURLIGHT-1 study of atirmociclib, a highly selective cyclin-dependent kinase (CDK) 4 inhibitor, plus fulvestrant in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (MBC) who had received prior CDK 4/6 inhibitor-based treatment. These results further support atirmociclib as a potential first-in-class cell cycle inhibitor backbone for HR+, HER2- MBC and Pfizer’s development strategy in earlier lines of therapy. A Phase 3 study in frontline MBC is ongoing and an additional Phase 3 study in early breast cancer is planned to evaluate atirmociclib in combination with giredestrant, an investigational oral selective oestrogen receptor degrader under development by Roche. (Presentation #1842O) Late-breaking overall survival (OS) and progression-free survival (PFS) results from the Phase 3 SigVie-002 study evaluating sigvotatug vedotin (SV), an investigational integrin β6 (IB6)-directed antibody-drug conjugate (ADC), as monotherapy in previously treated non-squamous non-small cell lung cancer (NSCLC). The findings will provide additional insight into previously announced topline results and inform the continued development of SV in earlier treatment settings, including an ongoing Phase 3 trial evaluating SV in combination with pembrolizumab in first-line advanced NSCLC and additional novel combinations under evaluation. (Presentation #LBA68) Updated Phase 2 data for tivunatamig (PF-08634404, PF’4404), a novel bispecific antibody targeting PD-1 and VEGF, in combination with chemotherapy in first-line PD-L1-expressing NSCLC. Tivunatamig is being developed as a potential best-in-class backbone therapy designed to combine two validated and complementary pathways in a single agent across tumor types, including ongoing pivotal studies in first-line NSCLC, first-line metastatic colorectal cancer, and advanced/recurrent endometrial cancer. Additional Phase 3 combination studies are planned, including with PADCEV ®(enfortumab vedotin-ejfv) in metastatic urothelial cancer. (Presentation #2660P) Expanding Evidence Across the Portfolio Updated exploratory analyses from the Phase 3 EV-302 trial evaluating outcomes with PADCEV plus pembrolizumab in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC), including among older patients, patients with comorbidities, and subgroups defined by disease-related characteristics. The findings further strengthen confidence in the regimen as a first-line foundation of care in la/mUC across clinically relevant populations. (Presentations #4760P and #4761P) Results from STARBOARD, a non-registrational Phase 3 trial evaluating an investigational triplet combination regimen of BRAFTOVI ®(encorafenib) and MEKTOVI ®(binimetinib) with pembrolizumab (KEYTRUDA ®) in first-line BRAF V600-mutant advanced melanoma. These findings contribute important evidence to an evolving treatment landscape. (Presentation #2071O) Deepening Understanding of Treatment Outcomes and Patient Experience Patient-reported outcomes and a safety analysis from the Phase 3 TALAPRO-3 study further supporting TALZENNA ®(talazoparib) plus XTANDI ® (enzalutamide) as a potential treatment option for men with homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC; also known as metastatic APMN/S prostate cancer). A supplemental New Drug Application (sNDA) for TALZENNA plus XTANDI in mAPMN/S is currently under Priority Review by the U.S. Food and Drug Administration (FDA). (Presentations #2222RO and #2231P) An ad-hoc analysis from the Phase 3 EV-303 trial (also known as KEYNOTE-905) and circulating tumor DNA (ctDNA) and health-related quality of life analyses from the Phase 3 EV-304 (KEYNOTE-B15) trial. These analyses provide important biological and patient-centered context to previously reported survival data and further support perioperative PADCEV plus pembrolizumab as a new potential standard of care in muscle-invasive bladder cancer (MIBC). (Presentations #4733O, #4734O and #4738RO) ESMO Presence Reinforces Pfizer Oncology's Strategy to Advance Standards of Care and Deliver Next-Generation Breakthroughs As cancer remains the second-leading cause of death worldwide, Pfizer is focused on generating the evidence needed to bring treatment breakthroughs to as many patients as possible. Our data at ESMO reflect that strategy, concentrating innovation in disease areas with the greatest opportunity to impact patients globally. Highlights include emerging data from late-stage investigational programs advancing next-generation treatments, new analyses supporting established medicines as standards of care, and insights that deepen understanding of patient experience to better inform clinical decisions. Detailed Presentation Information Information on significant Pfizer and partner-sponsored abstracts, including date and time of presentation, follows in the chart below. A complete list of Pfizer and partner-sponsored abstracts and presentations is available here. Pfizer is continuing its commitment to help non-scientists understand the latest findings with the development of abstract plain language summaries (aPLS) for company-sponsored research being presented at ESMO, which are written in non-technical language. Those interested in learning more can visit www.Pfizer.com/apls to access the summaries. Pfizer and Astellas have a clinical collaboration agreement with Merck to evaluate the combination of PADCEV® and KEYTRUDA® in patients with previously untreated metastatic urothelial cancer and MIBC regardless of cisplatin eligibility. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada). XTANDI® is jointly developed and commercialized by Pfizer and Astellas in the United States. Prescribing Information for Pfizer Medicines Please see full Prescribing Information for BRAFTOVI® (encorafenib) and full Prescribing Information for MEKTOVI® (binimetinib). Please see full Prescribing Information for PADCEV® (enfortumab vedotin-ejfv). Please see full Prescribing Information for TALZENNA® (talazoparib). Please see full Prescribing Information for XTANDI® (enzalutamide). About Pfizer Oncology At Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and multispecific antibodies, including immuno-oncology biologics. We are focused on delivering transformative therapies in some of the world’s most common cancers, including breast cancer, gastrointestinal cancer, genitourinary cancer, hematologic malignancies, and lung cancers. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website atwww.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at www.facebook.com/Pfizer/. Disclosure notice The information contained in this release is as of September 28, 2026. The Company assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer Oncology and Pfizer’s oncology portfolio of marketed and investigational therapies, including combinations, and including their potential benefits; expectations for our product pipeline, in-line products and product candidates, including anticipated regulatory submissions, data read-outs, study starts, approvals, launches, clinical trial results and other developing data; the development or commercial potential of our product pipeline, in-line products, product candidates and additional indications or combinations, including expected clinical trial protocols, the potential and timing for the initiation and progress of clinical trials and data read-outs from trials; the timing and potential for the submission of applications for and receipt of regulatory approvals; the timing and potential for product launches and commercialization; expected breakthrough, best- or first-in-class or blockbuster status or expected market entry of our medicines; potential patients reached; the regulatory landscape; the competitive landscape; and other statements about our business, operations and financial results that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risk and uncertainties include, among other things, uncertainties regarding the commercial success of Pfizer’s oncology portfolio; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim and preliminary data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any drug applications, biologics license applications and/or emergency use authorization applications may be filed in any jurisdictions for any potential indication for Pfizer’s product candidates; whether and when any such applications that may be pending or filed for any of Pfizer’s product candidates may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether any such product candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of Pfizer’s products or product candidates, including development of products or therapies by other companies; manufacturing capabilities or capacity; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws or regulations; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. Pfizer Media Contact: PfizerMediaRelations@Pfizer.com Pfizer Investor Relations: IR@pfizer.com Source: Pfizer Inc.

Phase 3Phase 2ASCOPriority Review

28 Sep 2026

·www.biospace.com

Pfizer Advances Today’s Cancer Care and Tomorrow’s Potential Breakthroughs at ESMO

Data across 45 abstracts will highlight new evidence for established medicines, including PADCEV and TALZENNA, and promising late-stage pipeline candidates such as atirmociclib and tivunatamig (PF’4404) NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) will present data from 45 company-sponsored, investigator-sponsored, and collaborative research abstracts at the European Society for Medical Oncology (ESMO) Congress, taking place October 23-27, 2026 in Madrid, Spain. The presentations include 11 oral presentations spanning Pfizer’s established medicines and late-stage pipeline across its disease areas of focus, including breast cancer, genitourinary cancers, and lung cancer. “At Pfizer Oncology, we're focused on improving outcomes for people living with cancer. That means continuing to raise the standard of care today while pursuing the breakthroughs that will shape the future of oncology. The data we're presenting at ESMO reflect that focus, strengthening the evidence behind medicines such as PADCEV and TALZENNA, while advancing promising investigational candidates including atirmociclib and tivunatamig. By building on our leadership in breast, genitourinary, and lung cancers, we're working to bring meaningful progress to patients today and for years to come.” - Jeff Legos, Chief Oncology Officer, Pfizer Key Highlights of Pfizer’s Presence at ESMO 2026 Guiding the Next Wave of Oncology Innovation Phase 2 randomized results from the FOURLIGHT-1 study of atirmociclib, a highly selective cyclin-dependent kinase (CDK) 4 inhibitor, plus fulvestrant in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (MBC) who had received prior CDK 4/6 inhibitor-based treatment. These results further support atirmociclib as a potential first-in-class cell cycle inhibitor backbone for HR+, HER2- MBC and Pfizer’s development strategy in earlier lines of therapy. A Phase 3 study in frontline MBC is ongoing and an additional Phase 3 study in early breast cancer is planned to evaluate atirmociclib in combination with giredestrant, an investigational oral selective oestrogen receptor degrader under development by Roche. (Presentation #1842O) Late-breaking overall survival (OS) and progression-free survival (PFS) results from the Phase 3 SigVie-002 study evaluating sigvotatug vedotin (SV), an investigational integrin β6 (IB6)-directed antibody-drug conjugate (ADC), as monotherapy in previously treated non-squamous non-small cell lung cancer (NSCLC). The findings will provide additional insight into previously announced topline results and inform the continued development of SV in earlier treatment settings, including an ongoing Phase 3 trial evaluating SV in combination with pembrolizumab in first-line advanced NSCLC and additional novel combinations under evaluation. (Presentation #LBA68) Updated Phase 2 data for tivunatamig (PF-08634404, PF’4404), a novel bispecific antibody targeting PD-1 and VEGF, in combination with chemotherapy in first-line PD-L1-expressing NSCLC. Tivunatamig is being developed as a potential best-in-class backbone therapy designed to combine two validated and complementary pathways in a single agent across tumor types, including ongoing pivotal studies in first-line NSCLC, first-line metastatic colorectal cancer, and advanced/recurrent endometrial cancer. Additional Phase 3 combination studies are planned, including with PADCEV ® (enfortumab vedotin-ejfv) in metastatic urothelial cancer. (Presentation #2660P) Expanding Evidence Across the Portfolio Updated exploratory analyses from the Phase 3 EV-302 trial evaluating outcomes with PADCEV plus pembrolizumab in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC), including among older patients, patients with comorbidities, and subgroups defined by disease-related characteristics. The findings further strengthen confidence in the regimen as a first-line foundation of care in la/mUC across clinically relevant populations. (Presentations #4760P and #4761P) Results from STARBOARD, a non-registrational Phase 3 trial evaluating an investigational triplet combination regimen of BRAFTOVI ® (encorafenib) and MEKTOVI ® (binimetinib) with pembrolizumab (KEYTRUDA ® ) in first-line BRAF V600-mutant advanced melanoma. These findings contribute important evidence to an evolving treatment landscape. (Presentation #2071O) Deepening Understanding of Treatment Outcomes and Patient Experience Patient-reported outcomes and a safety analysis from the Phase 3 TALAPRO-3 study further supporting TALZENNA ® (talazoparib) plus XTANDI ® (enzalutamide) as a potential treatment option for men with homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC; also known as metastatic APMN/S prostate cancer). A supplemental New Drug Application (sNDA) for TALZENNA plus XTANDI in mAPMN/S is currently under Priority Review by the U.S. Food and Drug Administration (FDA). (Presentations #2222RO and #2231P) An ad-hoc analysis from the Phase 3 EV-303 trial (also known as KEYNOTE-905) and circulating tumor DNA (ctDNA) and health-related quality of life analyses from the Phase 3 EV-304 (KEYNOTE-B15) trial. These analyses provide important biological and patient-centered context to previously reported survival data and further support perioperative PADCEV plus pembrolizumab as a new potential standard of care in muscle-invasive bladder cancer (MIBC). (Presentations #4733O, #4734O and #4738RO) ESMO Presence Reinforces Pfizer Oncology's Strategy to Advance Standards of Care and Deliver Next-Generation Breakthroughs As cancer remains the second-leading cause of death worldwide, Pfizer is focused on generating the evidence needed to bring treatment breakthroughs to as many patients as possible. Our data at ESMO reflect that strategy, concentrating innovation in disease areas with the greatest opportunity to impact patients globally. Highlights include emerging data from late-stage investigational programs advancing next-generation treatments, new analyses supporting established medicines as standards of care, and insights that deepen understanding of patient experience to better inform clinical decisions. Detailed Presentation Information Information on significant Pfizer and partner-sponsored abstracts, including date and time of presentation, follows in the chart below. A complete list of Pfizer and partner-sponsored abstracts and presentations is available here . LUNG CANCER Proffered Paper 1 LBA68 October 25, 2026 10:15–11:45 CET Phase 3 study of sigvotatug vedotin (SV) vs docetaxel in previously treated non-squamous non-small cell lung cancer (NSCLC) [ LBA ] Peters et al Poster Presentation 2660P October 26, 2026 12:00–12:45 CET Phase 2 trial of the PD-1/VEGF bispecific antibody, PF-08634404 (SSGJ-707), plus chemotherapy (chemo) in advanced NSCLC: Updated results [ 3SBio ] Wu et al BREAST CANCER Proffered Paper Session 1842O October 24, 2026 08:30–10:00 CET Efficacy and safety of atirmociclib (ATI) + fulvestrant (FUL) in patients (pts) with HR+/HER2– advanced/metastatic breast cancer (mBC) who progressed on prior CDK 4/6 inhibitor (CDK 4/6i) in a randomized phase 2 study (FOURLIGHT-1) Giordano et al Proffered Paper Session 1766RO October 24, 2026 10:15–11:45 CET Health-related quality of life from HER2CLIMB-05: A Phase 3 study of tucatinib versus placebo in combination with trastuzumab and pertuzumab as 1L maintenance therapy for HER2+ mBC Dieras et al GENITOURINARY CANCERS: BLADDER AND PROSTATE Rapid Oral Session 2219RO October 23, 2026 13:30–15:00 CET Utility of ctDNA tumor fraction (TF) as a prognostic biomarker in TALAPRO-3: Phase 3 study of talazoparib (TALA) + enzalutamide (ENZA) vs placebo (PBO) + ENZA in patients (pts) with homologous recombination repair (HRR) gene–mutated metastatic castration-sensitive prostate cancer (mCSPC) Azad et al Rapid Oral Session 2222RO October 23, 2026 13:30–15:00 CET Patient-reported outcomes (PROs) in men with metastatic castration-sensitive prostate cancer (mCSPC) and homologous recombination repair (HRR) gene alterations receiving talazoparib (TALA) + enzalutamide (ENZA) vs placebo (PBO) + ENZA: Results from the Phase 3 TALAPRO-3 study Azad et al Proffered Paper Session 4733O October 23, 2026 13:30–15:00 CET Perioperative pembrolizumab (pembro) or enfortumab vedotin (EV) plus pembro in patients (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible: Ad hoc analysis from KEYNOTE-905 [ MSD led ] Ullén et al Proffered Paper Session 4734O October 23, 2026 13:30–15:00 CET ctDNA analysis of the Phase 3 KEYNOTE-B15 trial: neoadjuvant and adjuvant (neoadj-adj) enfortumab vedotin (EV) + pembrolizumab (pembro) for participants (pts) with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin [ MSD led ] Chatzkel et al Poster Presentation 2296P October 23, 2026, 15:15-16:00 CET Safety and efficacy of mevrometostat monotherapy in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) J. Carles Galceran et al Poster Presentation 2231P October 23, 2026 15:15–16:00 CET Talazoparib (TALA) + enzalutamide (ENZA) in patients (pts) with metastatic castration-sensitive prostate cancer (mCSPC) with homologous recombination repair (HRR) gene alterations: Safety analyses from the Phase 3 TALAPRO-3 study Mateo et al Poster Presentation 4761P October 23, 2026 15:15–16:00 CET Enfortumab vedotin plus pembrolizumab (EV+P) for previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC): Updated exploratory analysis of EV-302 in older patients (pts) and those with comorbidities Sridhar et al Poster Presentation 4760P October 23, 2026 15:15–16:00 CET Enfortumab vedotin (EV) + pembrolizumab (P) in previously untreated locally advanced or metastatic urothelial cancer (la/mUC): Exploratory analyses based on disease-related characteristics from EV-302 Bedke et al Proffered Paper Session 4738RO October 24, 2026 10:15–11:45 CET Health-related quality of life (HRQoL) with neoadjuvant and adjuvant (neoadj-adj) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) eligible for cisplatin in the phase 3 KEYNOTE-B15 study [ MSD led ] Gómez De Liaño et al MELANOMA Proffered Paper Session 2071O October 23, 2026 16:15–17:45 CET STARBOARD Phase 3: A randomized, double-blind study of first-line (1L) encorafenib (enco), binimetinib (bini), and pembrolizumab (pembro) vs placebo (PBO) and pembro for unresectable locally advanced or metastatic BRAF V600-mutant melanoma Schadendorf et al Pfizer is continuing its commitment to help non-scientists understand the latest findings with the development of abstract plain language summaries (aPLS) for company-sponsored research being presented at ESMO, which are written in non-technical language. Those interested in learning more can visit to access the summaries. Pfizer and Astellas have a clinical collaboration agreement with Merck to evaluate the combination of PADCEV ® and KEYTRUDA ® in patients with previously untreated metastatic urothelial cancer and MIBC regardless of cisplatin eligibility. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada). XTANDI ® is jointly developed and commercialized by Pfizer and Astellas in the United States. Prescribing Information for Pfizer Medicines Please see full Prescribing Information for BRAFTOVI ® (encorafenib) and full Prescribing Information for MEKTOVI ® (binimetinib). Please see full Prescribing Information for PADCEV ® (enfortumab vedotin-ejfv). Please see full Prescribing Information for TALZENNA ® (talazoparib). Please see full Prescribing Information for XTANDI ® (enzalutamide). About Pfizer Oncology At Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and multispecific antibodies, including immuno-oncology biologics. We are focused on delivering transformative therapies in some of the world’s most common cancers, including breast cancer, gastrointestinal cancer, genitourinary cancer, hematologic malignancies, and lung cancers. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at . In addition, to learn more, please visit us on and follow us on X at @Pfizer and @Pfizer_News , LinkedIn , YouTube and like us on Facebook at . Disclosure notice The information contained in this release is as of September 28, 2026. The Company assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer Oncology and Pfizer’s oncology portfolio of marketed and investigational therapies, including combinations, and including their potential benefits; expectations for our product pipeline, in-line products and product candidates, including anticipated regulatory submissions, data read-outs, study starts, approvals, launches, clinical trial results and other developing data; the development or commercial potential of our product pipeline, in-line products, product candidates and additional indications or combinations, including expected clinical trial protocols, the potential and timing for the initiation and progress of clinical trials and data read-outs from trials; the timing and potential for the submission of applications for and receipt of regulatory approvals; the timing and potential for product launches and commercialization; expected breakthrough, best- or first-in-class or blockbuster status or expected market entry of our medicines; potential patients reached; the regulatory landscape; the competitive landscape; and other statements about our business, operations and financial results that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risk and uncertainties include, among other things, uncertainties regarding the commercial success of Pfizer’s oncology portfolio; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim and preliminary data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any drug applications, biologics license applications and/or emergency use authorization applications may be filed in any jurisdictions for any potential indication for Pfizer’s product candidates; whether and when any such applications that may be pending or filed for any of Pfizer’s product candidates may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether any such product candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of Pfizer’s products or product candidates, including development of products or therapies by other companies; manufacturing capabilities or capacity; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws or regulations; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at and . Contacts Pfizer Media Contact: PfizerMediaRelations@Pfizer.com Pfizer Investor Relations: IR@pfizer.com

Phase 3Phase 2Clinical ResultASCOPriority Review

10 Aug 2026

·ir.olema.com

Olema Oncology Reports Second Quarter 2026 Financial and Operating Results

Completed enrollment in the pivotal Phase 3 OPERA-01 trial; top-line data are now expected in the first quarter of 2027 Presented initial Phase 1 clinical data for OP-3136 at the 2026 ASCO Annual Meeting Announced a clinical trial collaboration and supply agreement with Bayer to evaluate darolutamide in combination with OP-3136 in metastatic castration-resistant prostate cancer Ended the second quarter with $461.1 million in cash, cash equivalents, and marketable securities SAN FRANCISCO, Aug. 10, 2026 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology”, Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, today reported financial and operating results for the second quarter ended June 30, 2026. “Our commitment to transforming the metastatic breast cancer treatment paradigm remains resolute as we continue to advance palazestrant as a potentially differentiated endocrine therapy across multiple regimens. Importantly, enrollment in our pivotal OPERA-01 Phase 3 trial is complete and we now expect to report top-line data in the first quarter of 2027,” said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. “Beyond palazestrant, we made significant progress with OP-3136, our novel KAT6 inhibitor. The initial monotherapy Phase 1 data, presented at ASCO, demonstrated that OP-3136 was well-tolerated and showed evidence of anti-tumor activity across multiple dose levels and various tumor types. These data, taken together with our first clinical collaboration for OP-3136, established with Bayer to evaluate OP-3136 in combination with darolutamide in metastatic castration-resistant prostate cancer, reinforce our confidence in its potential as a best-in-class, differentiated option for patients with advanced solid tumors.” Bohen continued, “Supported by a strong balance sheet, we are intently focused on execution in the second half of the year as we ramp preparations for our first potential commercial launch of palazestrant as a monotherapy, work to establish palazestrant as a potential combination agent of choice in breast cancer, and continue our transformation into a fully integrated oncology company.” Recent Progress Completed enrollment in the pivotal Phase 3 OPERA-01 trial of palazestrant as a monotherapy in patients with second or third-line estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (MBC). Presented initial Phase 1 clinical data for OP-3136 as a monotherapy in multiple solid tumor types and a trial-in-progress poster for the pivotal Phase 3 OPERA-02 trial evaluating palazestrant in combination with ribociclib in frontline ER+/HER2- MBC at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. Announced a clinical trial collaboration and supply agreement with Bayer to evaluate OP-3136 in combination with darolutamide, Bayer's androgen receptor inhibitor, in patients with metastatic castration-resistant prostate cancer (mCRPC). Completed enrollment in the Phase 1b/2 study of palazestrant in combination with atirmociclib in ER+/HER2- MBC. Advanced enrollment in the pivotal Phase 3 OPERA-02 trial and the Phase 1 study of OP-3136 as a monotherapy and in combination with fulvestrant and palazestrant in ER+/HER2- MBC. Anticipated Upcoming Events Initiate enrollment in the Phase 1b/2 study evaluating OP-3136 in combination with darolutamide in mCRPC in collaboration with Bayer in the fourth quarter of 2026. Report top-line data from the pivotal Phase 3 OPERA-01 trial in the first quarter of 2027. Second Quarter 2026 Financial Results Cash, cash equivalents, and marketable securities as of June 30, 2026, were $461.1 million. Net loss for the quarter ended June 30, 2026 was $63.2 million, as compared to $43.8 million for the quarter ended June 30, 2025. The increase in net loss for the second quarter was related to higher spending on clinical development and research and corporate-related activities related to late-stage clinical trials for palazestrant and the advancement of OP-3136. GAAP research and development (R&D) expenses were $57.8 million for the quarter ended June 30, 2026, as compared to $43.9 million for the quarter ended June 30, 2025. The increase in R&D expenses was primarily related to increased spending on clinical development-related activities as we continue to advance palazestrant through late-stage clinical trials and OP-3136 in early-stage clinical studies, and increased personnel-related costs to support expanding development activities, including an increase in non-cash stock-based compensation expense of $5.2 million, mainly due to higher grant prices in 2026 and higher headcount. These increases were partially offset by the $10.0 million milestone expense related to the Aurigene agreement that was recognized in the same period in 2025. Non-GAAP R&D expenses were $48.9 million for the quarter ended June 30, 2026, excluding $8.9 million non-cash stock-based compensation expense. Non-GAAP R&D expenses were $40.2 million for the quarter ended June 30, 2025, excluding $3.7 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release. GAAP G&A expenses were $9.4 million for the quarter ended June 30, 2026, as compared to $4.0 million for the quarter ended June 30, 2025. The increase in G&A expenses was primarily due to higher corporate-related costs that reflect continued investment in personnel and corporate infrastructure to support our expanding late-stage clinical development activities and anticipated future commercial operations, including an increase in non-cash stock-based compensation expense of $3.0 million, mainly due to higher grant prices in 2026, and an increase in professional fees of $1.8 million. Non-GAAP G&A expenses were $5.4 million for the quarter ended June 30, 2026, excluding $4.0 million non-cash stock-based compensation expense. Non-GAAP G&A expenses were $3.0 million for the quarter ended June 30, 2025, excluding $1.0 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release. About Olema Oncology Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. Olema is advancing a pipeline of novel therapies by leveraging our deep understanding of endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance. Our lead product candidate, palazestrant (OP-1250), is a proprietary, orally available complete estrogen receptor antagonist (CERAN) and a selective estrogen receptor degrader (SERD), currently in two Phase 3 clinical trials. In addition, Olema is developing OP-3136, a potent lysine acetyltransferase 6 (KAT6) inhibitor, now in a Phase 1 clinical study. Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit www.olema.com. About Palazestrant (OP-1250) Palazestrant (OP-1250) is a novel, orally available small molecule with dual activity as both a complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD). It is currently being investigated in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In clinical studies, palazestrant completely blocks ER-driven transcriptional activity in both wild-type and mutant forms of metastatic ER+ breast cancer and has demonstrated anti-tumor efficacy along with attractive pharmacokinetics and exposure, favorable tolerability, central nervous system penetration, and combinability with cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. Palazestrant has been granted U.S. Food and Drug Administration (FDA) Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. It is being evaluated as a single agent in the ongoing pivotal Phase 3 clinical trial, OPERA-01, and in combination with ribociclib in the ongoing pivotal Phase 3 clinical trial, OPERA-02. Palazestrant is also being evaluated in multiple Phase 1/2 studies in combination with ribociclib, palbociclib, alpelisib, everolimus, and atirmociclib. About OP-3136 OP-3136 is a novel, orally available small molecule that potently and selectively inhibits lysine acetyltransferase 6 (KAT6), an epigenetic target that is dysregulated in breast and other cancers. In preclinical studies, OP-3136 has demonstrated significant anti-proliferative activity in ER+ breast cancer models and is combinable and synergistic with endocrine therapies including palazestrant and cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. The Investigational New Drug (IND) application for OP-3136 was cleared by the U.S. Food and Drug Administration (FDA) in December 2024 and patients are currently enrolling in the Phase 1 clinical study. Non-GAAP Financial Information The results presented in this press release include both GAAP information and non-GAAP information. As used in this release, non-GAAP R&D expense is defined by Olema as GAAP R&D expense excluding stock-based compensation expense, and non-GAAP G&A expense is defined by Olema as GAAP G&A expense excluding stock-based compensation expense. We use these non-GAAP financial measures to evaluate our ongoing operations and for internal planning and forecasting purposes. We believe that non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental informational purposes only, has limitations as an analytical tool, and should not be considered in isolation or as a substitute for financial information presented in accordance with GAAP. Other companies, including companies in our industry, may calculate similarly titled non-GAAP measures differently or may use other measures to evaluate their performance, all of which could reduce the usefulness of our non-GAAP financial measures as tools for comparison. Investors are encouraged to review the related GAAP financial measures and the reconciliation of these non-GAAP financial measures to their most directly comparable GAAP financial measures and not rely on any single financial measure to evaluate our business. Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Words such as “anticipate,” “believe,” “could,” “expect,” “goal,” “intend,” “may,” “on track,” “potential,” “upcoming,” “will” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include those related to the continued advancement of Olema’s pipeline of product candidates, including palazestrant and OP-3136; the progress, timing, and results of Olema’s clinical trials, including the Phase 3 OPERA-01 and OPERA-02 trials and ongoing Phase 1/2 studies; the expected timing of data readouts, including top-line data from OPERA-01; the potential therapeutic effects and benefits of palazestrant and OP-3136, alone or in combination with each other or with other agents; the potential for palazestrant to serve as a differentiated endocrine therapy across multiple regimens and to transform the metastatic breast cancer treatment paradigm; the potential for OP-3136 to be a best-in-class, differentiated option for patients with advanced solid tumors; the expected benefits of Olema's collaboration with Bayer; Olema’s plans to become a fully integrated oncology company; and Olema’s commercial launch preparations. These forward-looking statements are subject to risks and uncertainties, including, without limitation, those discussed in the section titled “Risk Factors” in Olema’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, and future filings and reports that Olema makes from time to time with the U.S. Securities and Exchange Commission. Except as required by law, Olema assumes no obligation to update these forward-looking statements, including in the event that actual results differ materially from those anticipated in the forward-looking statements. Media and Investor Relations Contact Courtney O’Konek Vice President, Corporate Communications Olema Oncology media@olema.com Olema Pharmaceuticals, Inc. Condensed Consolidated Balance Sheets Data (Unaudited) (In thousands) June 30,December 31, 2026 2025 Cash, cash equivalents and marketable securities $461,070$505,437 Total assets 486,578 533,430 Total current liabilities 53,014 51,802 Total liabilities 56,014 54,871 Total stockholders’ equity 430,564 478,559 Total liabilities and stockholders’ equity $486,578$533,430 Olema Pharmaceuticals, Inc. Condensed Consolidated Statements of Operations (Unaudited) (In thousands, except for share and per share data) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Operating expenses: Research and development (1)$57,785 $43,902 $107,017 $74,526 General and administrative (2) 9,394 3,962 18,148 8,211 Total operating expenses 67,179 47,864 125,165 82,737 Loss from operations (67,179) (47,864) (125,165) (82,737) Other income: Interest income 4,507 4,042 9,283 8,566 Other (loss) income (528) 38 (407) (2) Total other income 3,979 4,080 8,876 8,564 Net loss$(63,200)$(43,784) $(116,289)$(74,173) Net loss per share, basic and diluted$(0.61)$(0.51) $(1.12)$(0.87) Weighted average shares used to compute net loss per share, basic and diluted (3) 104,453,732 85,497,426 103,631,483 85,462,021 (1) Research and development expenses for the three- and six-months ended June 30, 2025 include a $10.0 million milestone payment in connection with the Aurigene Agreement. (1) and (2) Used to reference to the table below. (3) The weighted average shares used to compute net loss per share, basic and diluted include the effect from the pre-funded warrants. Reconciliation of GAAP to Non-GAAP Information (In thousands) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 (1) Research and development reconciliation GAAP research and development$ 57,785 $ 43,902 $ 107,017 $ 74,526 Less: stock-based compensation expense 8,891 3,709 15,462 7,010 Non-GAAP research and development$ 48,894 $ 40,193 $ 91,555 $ 67,516 (2) General and administrative reconciliation GAAP general and administrative$ 9,394 $ 3,962 $ 18,148 $ 8,211 Less: stock-based compensation expense 4,012 983 7,589 2,060 Non-GAAP general and administrative$ 5,382 $ 2,979 $ 10,559 $ 6,151

Phase 1Phase 3Financial StatementFast TrackASCO

100 Deals associated with Atirmociclib

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D12834	-	-	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Early Stage Breast Carcinoma	Phase 3	-	Pfizer Inc.	01 Dec 2026
ER-positive/HER2-negative Breast Cancer	Phase 3	-	Pfizer Inc.	01 Dec 2026
Hormone receptor positive HER2 negative breast cancer	Phase 3	United States	Pfizer Inc.	06 Jan 2025
Hormone receptor positive HER2 negative breast cancer	Phase 3	China	Pfizer Inc.	06 Jan 2025
Hormone receptor positive HER2 negative breast cancer	Phase 3	Japan	Pfizer Inc.	06 Jan 2025
Hormone receptor positive HER2 negative breast cancer	Phase 3	Argentina	Pfizer Inc.	06 Jan 2025
Hormone receptor positive HER2 negative breast cancer	Phase 3	Australia	Pfizer Inc.	06 Jan 2025
Hormone receptor positive HER2 negative breast cancer	Phase 3	Belgium	Pfizer Inc.	06 Jan 2025
Hormone receptor positive HER2 negative breast cancer	Phase 3	Brazil	Pfizer Inc.	06 Jan 2025
Hormone receptor positive HER2 negative breast cancer	Phase 3	Bulgaria	Pfizer Inc.	06 Jan 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06206837 (TACTIVE-K, CTgov)	Phase 1/2	ER-positive/HER2-negative Breast Cancer	71	PF-07220060+Vepdegestrant (Phase 1b: Vepdegestrant 200 mg QD + PF-07220060 100 mg BID)	mkkcbpmcrt = ygjvcnbybr ourzfgmuyt (zlmefdqwdr, voqltrqfid - cdjzxpcqda) View more	-	30 Sep 2026
				PF-07220060+Vepdegestrant (Phase 1b: Vepdegestrant 200 mg QD + PF-07220060 300 mg BID)	mkkcbpmcrt = pnulkqywuo ourzfgmuyt (zlmefdqwdr, uwrygarbnf - eumtkgqjcy) View more
NCT06465368 (FourLight-2, CTgov)	Phase 2	Hormone receptor positive HER2 negative breast cancer	121	PF-07220060+Letrozole (PF-07220060 + Letrozole)	samopcxacv = yfxaxztqrd npnsqlbyhl (rrkitqdpej, dxqhvjgkni - fmrklebijp) View more	-	15 Jul 2026
				Letrozole (Letrozole Alone)	samopcxacv = bvlifvpdvr npnsqlbyhl (rrkitqdpej, pvsaziiaql - kfwpbuhgdw) View more
NCT06465368 (FourLight-2, ASCO2026)	Phase 2	Hormone receptor positive HER2 negative breast cancer Neoadjuvant HR+ \| HER2−	121	Atirmociclib +Letrozole	spfocilffs(cwpbhhhxdu) = qwzrxxvjyi wxukdmefji (bhiljnbtyv, 76.6 - 94.5) View more	Positive	29 May 2026
				Letrozole	spfocilffs(cwpbhhhxdu) = axscdgfhcs wxukdmefji (bhiljnbtyv, 10.0 - 29.8) View more
NCT06105632 (FOURLIGHT-1, Company_Website) Manual	Phase 2	Hormone receptor positive HER2 negative breast cancer Second line HER2 Negative \| HR Positive	264	Atirmociclib + Fulvestrant	urbpzswdot(djpubruuvq): HR = 0.6 (95.0% CI, 0.44 - 0.825), P-Value = 0.0007 Met View more	Positive	17 Mar 2026
				fulvestrant+exemestane or everolimus + exemestane
NCT06267963 (CTgov)	Phase 1	-	12	PF-07220060 (Cohort 1: 14C PF-07220060 100 mg Oral)	quisleauws(ckwqnwopxl) = gjktfwfmxw hgowbrmgpx (sondyedohn, 3.0) View more	-	10 Mar 2026
				PF-07220060 (Cohort 2: PF-07220060 100 mg Oral + 14C PF-07220060 100 mcg IV)	quisleauws(ckwqnwopxl) = dnhbnsusco hgowbrmgpx (sondyedohn, 3.0) View more
NCT06760637 (ESMO2025)	Phase 3	Advanced breast cancer First line HR+/HER2−	1,020	Atirmociclib plus letrozole	jgqmjhkydi(rggrojjpgv) = qbiwefknbv rerudrrjoa (uipdwdlsuy, 36.0 - NR) View more	Positive	17 Oct 2025
				CDK4/6 inhibitor plus letrozole	cqkjuprowh(ojahhonmkx) = fpduzyqlus nqhjgqmqyu (ipgsraxagd, NR - 37+) View more
NCT06465368 (ESMO2025)	Phase 2	Early Stage Breast Carcinoma First line HR+/HER2−	118	AtirmociclibLetrozolelib + AtirmociclibLetrozole	fisiotkhud(qztijvfzbc) = Atirmociclib plus letrozole had a higher incidence of any-grade pneumonitis (10.3% vs 0.9%) and any-grade rash maculo-papular (16.9% vs 0%). qafzsqbbtg (kswwjayyyt )	Positive	17 Oct 2025
				Letrozole
NCT04557449 (ESMO2025)	Phase 1	Metastatic breast cancer First line HR+ \| HER2-	34	Atirmociclib + letrozole (HR+/HER2− metastatic breast cancer)	wrlbzjkfbd(iwvhhjjyod) = AEs led to a single dose reduction in 6 pts (17.6%): 2 in cycles 3−6, 1 in cycles 7−12, 2 in cycles 13−24 and 1 in cycles ≥25 rucyikvndp (edrtgwwlbb ) View more	Positive	17 Oct 2025
NCT04557449 (Phase I study, ESMO_BC2025)	Phase 1/2	Hormone receptor positive HER2 negative breast cancer Thymidine kinase	58	Atirmociclib 300 mg BID + Letrozole	tiscjtivde(kuhuocbyfb) = tstuqionti lnivpeampm (uxghxdnnbc )	Positive	14 May 2025
				Atirmociclib 400 mg BID + Letrozole	tiscjtivde(kuhuocbyfb) = joguczcptu lnivpeampm (uxghxdnnbc )
NCT04557449 (phase I/IIa study, ESMO2024)	Phase 1/2	Metastatic breast cancer ESR1 \| PIK3CA \| TP53	33	PF-07220060 + Fulvestrant	prteekhtwv(fpkutnfgam) = roxyxffaiq rzoufymifh (fsetjadsyx )	Positive	16 Sep 2024
				PF-07220060 + Letrozole	prteekhtwv(fpkutnfgam) = njgskkhuzb rzoufymifh (fsetjadsyx )

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