Pfizer Inc. is set to present a comprehensive array of clinical data across its oncology portfolio at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30 to June 3, 2025, in Chicago. The pharmaceutical giant will showcase findings from more than 60 abstracts spanning its key tumor focus areas, including 9 oral presentations and 6 rapid oral presentations.
"This has already been a significant year for Pfizer's Oncology pipeline, with multiple Phase 3 data readouts and regulatory approvals, and the initiation of pivotal registrational programs across our major tumor areas of focus," said Chris Boshoff, MD, PhD, Chief Scientific Officer and President, Research & Development, Pfizer. "The depth and diversity of our data presentations at ASCO are building on that momentum to bring us closer to our goal of delivering eight breakthrough cancer medicines by 2030."
Spotlight on Late-Breaking Presentations
Two of Pfizer's late-breaking presentations will be featured in ASCO's embargoed pre-meeting press briefing on May 27. The first will present primary analysis of overall survival (OS) and progression-free survival (PFS) results from the Phase 3 BREAKWATER study investigating BRAFTOVI (encorafenib) in combination with cetuximab and mFOLFOX6 in patients with BRAF V600E-mutant metastatic colorectal cancer. These pivotal results follow the FDA's accelerated approval of the BRAFTOVI combination regimen in late 2024.
The second highlighted presentation will reveal progression-free survival data from the Phase 3 VERITAC-2 study of vepdegestrant in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer, developed in partnership with Arvinas. These detailed findings follow the topline results announced earlier this year.
Extending the Impact of Established Therapies
Pfizer will share five-year survival data from the Phase 3 ARCHES study of XTANDI (enzalutamide) in combination with androgen deprivation therapy in metastatic hormone-sensitive prostate cancer (mHSPC). This long-term follow-up data further underscores the value of XTANDI across its approved indications.
In multiple myeloma, the company will present the first combination data for ELREXFIO (elranatamab) with daratumumab and lenalidomide from the ongoing MagnetisMM-6 study in patients with transplant-ineligible newly diagnosed multiple myeloma. These initial safety and efficacy results will help determine the recommended Phase 3 dose for the next stage of development.
Novel Antibody-Drug Conjugate Combinations
A significant focus of Pfizer's ASCO presentations will be on novel vedotin antibody-drug conjugates (ADCs) in combination with immune checkpoint inhibitors. For the first time, the company will present encouraging Phase 1 data on two investigational ADCs combined with pembrolizumab in thoracic cancers:
- Sigvotatug vedotin (SV), an integrin beta-6 (IB6)-directed ADC, in lung cancer and head and neck cancers
- PDL1V (PF-08046054), a PD-L1 directed ADC, in head and neck cancers
Additionally, new exploratory analyses will be presented from the pivotal EV-302 trial with PADCEV (enfortumab vedotin) in combination with KEYTRUDA (pembrolizumab) in patients with previously untreated locally advanced or metastatic urothelial carcinoma.
Advancing Early-Stage Pipeline
Several presentations will highlight updated results from ongoing Phase 1 studies that inform the dosing strategy in registrational programs for two molecules targeting epigenetic regulators:
- Mevrometostat, an investigational EZH2 inhibitor being evaluated in combination with XTANDI for metastatic castration-resistant prostate cancer (mCRPC)
- PF-07248144, a potential first-in-class KAT6 inhibitor for ER+/HER2- metastatic breast cancer (mBC)
"Our data at ASCO this year reflect how we are strategically progressing our deep pipeline of next generation cancer medicines while simultaneously extending the impact of our foundational therapies to reach more people living with cancer," said Megan O'Meara, Head of Early-Stage Development and Interim Head of Late-Stage Development, Pfizer Oncology. "Important early-stage updates highlight our extensive pipeline and depth within our core cancer types, as we advance up to nine new pivotal Phase 3 trials this year."
Colorectal Cancer Advancements
The BREAKWATER study results for BRAFTOVI in BRAF V600E-mutant metastatic colorectal cancer represent a significant advancement in this difficult-to-treat patient population. The combination of BRAFTOVI with cetuximab and mFOLFOX6 chemotherapy builds on previous findings that led to the regimen's accelerated approval by the FDA in 2024.
Breast Cancer Innovation
In addition to the vepdegestrant data in the VERITAC-2 study, Pfizer will present dose optimization data for PF-07248144, a potential first-in-class KAT6 inhibitor, in patients with ER+/HER2- metastatic breast cancer. These results will support the recommended dosing for the Phase 3 trial planned to begin in the second half of 2025.
Roche will also present detailed results from the overall survival analysis of the Phase 3 INAVO120 study investigating ITOVEBI (inavolisib) in combination with Pfizer's IBRANCE (palbociclib) and fulvestrant in patients with PIK3CA-mutated, HR+/HER2-, endocrine-resistant, locally advanced or metastatic breast cancer.
Genitourinary Cancer Progress
Beyond the five-year follow-up data for XTANDI in mHSPC, updates from the Astellas-supported, investigator-sponsored ENZAMET Phase 3 research study will be presented, including 8-year outcomes in men with mHSPC. These presentations further establish the long-term value of XTANDI across its approved indications.
For PADCEV, additional updates from the Phase 3 EV-302 study in combination with KEYTRUDA in previously untreated locally advanced or metastatic urothelial carcinoma will include an oral presentation with exploratory analysis of responders and a poster presentation on long-term subgroup analysis.
Commitment to Scientific Communication
Pfizer continues 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 ASCO. These summaries, written in non-technical language, will be available starting May 22, 2025, at www.Pfizer.com/apls.
The breadth and depth of Pfizer's ASCO 2025 presentations reflect the company's strategic approach to oncology drug development, focusing on both extending the impact of established therapies and advancing novel mechanisms to address unmet needs across multiple cancer types.
