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)

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 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 at www.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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260928374667/en/

Pfizer Media Contact:

PfizerMediaRelations@Pfizer.com

Pfizer Investor Relations:

IR@pfizer.com