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    Pfizer Highlights Momentum in Redefining Standards of Care in Cancer at ESMO 2025

    9/25/25 6:45:00 AM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $PFE alert in real time by email

    More than 45 abstracts, including five late-breaking presentations and recognition in Presidential Symposium, showcase impact of approved medicines and potential of next-generation pipeline

    Pfizer Inc. (NYSE: PFE) will highlight data across its extensive Oncology portfolio at the European Society for Medical Oncology (ESMO) Congress 2025, being held October 17-21 in Berlin, Germany. Data from more than 45 company-sponsored, investigator-sponsored, and collaborative research abstracts, including 11 oral/mini oral presentations and five late-breaking sessions, will be presented across Pfizer's core scientific modalities and key tumor areas.

    "At ESMO, Pfizer is demonstrating how earlier interventions with our innovative medicines have the potential to deliver greater impact to even more patients," said Jeff Legos, Chief Oncology Officer, Pfizer. "The survival benefits we're seeing across certain cancer types reinforce our commitment to accelerating innovative medicines that bring new hope to patients everywhere, while pipeline data highlight the next wave of potential breakthroughs that could transform care for even more people living with cancer."

    Pfizer will share highlights from its leading Oncology portfolio at ESMO, including:

    • In a Presidential Symposium, unprecedented survival results from the Phase 3 EV-303 trial (KEYNOTE-905) evaluating PADCEV® (enfortumab vedotin-ejfv), a Nectin-4 directed antibody-drug conjugate (ADC), plus KEYTRUDA® (pembrolizumab)* in patients with muscle-invasive bladder cancer who are ineligible for or declined cisplatin-based chemotherapy, showing potential to redefine standard of care in these patients (Presentation #LBA2)
    • Final overall survival results from the Phase 3 EMBARK trial evaluating XTANDI® (enzalutamide)** in combination with leuprolide and as monotherapy in non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence, highlighting the benefit of XTANDI in this earlier line of treatment (Presentation #LBA87)
    • Updated overall survival data from the Phase 2 PHAROS study of BRAFTOVI® (encorafenib) plus MEKTOVI® (binimetinib)*** in patients with BRAF V600E-mutant metastatic non-small cell lung cancer (NSCLC), reinforcing this combination as a potential key treatment option for these patients (Presentation #1849MO)

    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.

    Presentation Title

    Details

    Genitourinary Cancer

     

    Perioperative (periop) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible: The phase 3 KEYNOTE-905 study [Merck/MSD-led]

     

    Vulsteke et. al

    Presidential Symposium (Presentation #LBA2)

    Saturday, October 18, 2025, 4:30 PM CEST

     

    Disitamab vedotin (DV) plus toripalimab (T) versus chemotherapy (C) in first-line (1L) locally advanced or metastatic urothelial carcinoma (la/mUC) with HER2-expression [Remegen-led]

     

    Sheng et. al

    Presidential Symposium (Presentation #LBA7)

    Sunday, October 19, 2025, 4:30 PM CEST

     

    Overall survival with enzalutamide in biochemically recurrent prostate cancer

     

    Freedland et. al

    Oral Presentation (Presentation #LBA87)

    Sunday, October 19, 2025, 10:55 AM CEST

     

    Randomised phase 3 trial of androgen deprivation therapy (ADT) with radiation therapy with or without enzalutamide for high risk, clinically localised prostate cancer: ENZARAD (ANZUP 1303)****

     

    Nguyen et. al

    Oral Presentation (Presentation #LBA86)

    Sunday, October 19, 2025, 10:15 AM CEST

    Thoracic Cancer

     

    Updated overall survival analysis from the phase 2 PHAROS study of encorafenib plus binimetinib in patients with BRAF V600E-mutant metastatic NSCLC (mNSCLC)

     

    Johnson et. al

    Mini Oral Presentation (Presentation #1849MO)

    Sunday, October 19, 2025, 8:30 AM CEST

     

    Enfortumab vedotin plus pembrolizumab (EV + P) as first-line (1L) treatment in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC): results from a cohort of the EV-202 trial [Astellas led]

     

    Swiecicki et. al

    Mini Oral Presentation (Presentation #1329MO)

    Sunday, October 19, 2025, 4:30 PM CEST

     

     

    Breast Cancer

     

    Health-Related Quality of Life (HRQoL) from the PATINA Trial (AFT-38): Impact of Adding Palbociclib to HER2 and Endocrine Therapy (ET) after Induction in HR+/HER2+ Metastatic Breast Cancer (MBC)

     

    Ines Vaz-Luis et. al

    Mini Oral Presentation (Presentation #485MO)

    Monday, October 20, 2025, 10:15 AM CEST

     

     

    Patient-reported outcomes (PROs) with vepdegestrant (VEP) vs fulvestrant (FUL) in patients (pts) with estrogen receptor (ER) 1 gene mutated (ESR1m) ER+/human epidermal growth factor receptor 2 (HER2)−advanced breast cancer (aBC) in the phase 3 VERITAC-2 trial*****

     

    Campone et. al

    Mini Oral Presentation (Presentation #489MO)

    Monday, October 20, 2025, 10:15 AM CEST

    Gastrointestinal Cancer

     

    Circulating tumor (ct) DNA analysis of BRAF V600E dynamics and changes in genomic landscape in patients (pts) with first-line (1L) BRAF V600E-mutant metastatic colorectal cancer (mCRC) treated in BREAKWATER******

     

    Kopetz et. al

    Mini Oral Presentation (Presentation #729O)

    Monday, October 20, 2025, 08:30 AM CEST

     

    Cancer-Related Conditions

     

    Efficacy and safety of ponsegromab in patients with cancer-associated cachexia: Results from the open-label extension of a randomized, placebo-controlled, Phase 2 study

     

    Crawford et. al

    Oral Presentation (Presentation #LBA102)

    Friday, October 17, 2025, 4:00 PM CEST

     

    * 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.

    ** XTANDI® is jointly developed and commercialized by Pfizer and Astellas in the United States.

    *** The PHAROS trial is conducted with support from Pierre Fabre.

    **** Led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group Limited (ANZUP) with Astellas funding

    ***** Pfizer and Arvinas have a global collaboration for the co-development and co-commercialization of vepdegestrant.

    ****** The BREAKWATER trial was conducted with support from ONO Pharmaceutical, Merck KGaA, Darmstadt, Germany and Eli Lilly and Company.

    Prescribing Information for Pfizer Medicines

    Please see full Prescribing Information, including BOXED WARNING, for PADCEV® (enfortumab vedotin).

    Please see full Prescribing Information for XTANDI® (enzalutamide).

    Please see full Prescribing Information for BRAFTOVI® (encorafenib).

    Please see full Prescribing Information for MEKTOVI® (binimetinib).

    Please see full Prescribing Information for IBRANCE® (palbociclib) tablets and IBRANCE® (palbociclib) capsules.

    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 other immune-oncology biologics. We are focused on delivering transformative therapies in some of the world's most common cancers, including breast cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer. 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 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 Facebook.com/Pfizer.

    Disclosure Notice

    The information contained in this release is as of September 25, 2025. 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, Pfizer's Oncology portfolio of marketed and investigational therapies, including combinations, and an investigational therapy for a cancer-related condition; expectations for our product pipeline, in-line products and product candidates, including their potential benefits, clinical trial results and other developing data; potential breakthrough, best- or first-in-class or blockbuster status or expected market entry of our medicines; 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. Risks 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, 2024 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/20250925011729/en/

    Media Contact: [email protected]

    Investor Contact: [email protected]

    Get the next $PFE alert in real time by email

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