Pfizer to Showcase Advancements Across Genitourinary Cancers at ASCO GU Cancers Symposium
Pfizer (PFE) will present significant advancements in genitourinary cancer treatments at the ASCO GU Cancers Symposium in San Francisco. The company will showcase more than 20 abstracts, including five oral presentations, focusing on prostate and bladder cancers.
Key highlights include detailed overall survival results from the Phase 3 TALAPRO-2 trial of TALZENNA® with XTANDI® in metastatic castration-resistant prostate cancer, which demonstrated statistically significant improvements. Updated analysis from the Phase 3 EV-302 trial shows sustained overall survival benefits of PADCEV® combined with pembrolizumab in advanced urothelial cancer.
The company will also present the first randomized progression-free survival data for mevrometostat with XTANDI in mCRPC. Pfizer's genitourinary portfolio includes seven approved medicines across bladder, prostate, and kidney cancers, with TALZENNA-XTANDI combination already approved in over 35 countries globally.
Pfizer (PFE) presenterà significativi progressi nei trattamenti contro i tumori genito-urinari al Simposio ASCO GU Cancers di San Francisco. L'azienda mostrerà oltre 20 abstract, inclusi cinque presentazioni orali, concentrandosi sui tumori della prostata e della vescica.
I punti salienti includono risultati dettagliati sulla sopravvivenza globale dal trial di Fase 3 TALAPRO-2 su TALZENNA® con XTANDI® nel carcinoma prostatico metastaticamente resistente alla castrazione, che ha dimostrato miglioramenti statisticamente significativi. L'analisi aggiornata del trial di Fase 3 EV-302 mostra benefici sostenuti in termini di sopravvivenza globale per PADCEV® combinato con pembrolizumab nel carcinoma uroteliale avanzato.
L'azienda presenterà anche i primi dati randomizzati sulla sopravvivenza libera da progressione per mevrometostat con XTANDI nel mCRPC. Il portafoglio genito-urinario di Pfizer include sette medicinali approvati per i tumori della vescica, della prostata e del rene, con la combinazione TALZENNA-XTANDI già approvata in oltre 35 paesi a livello globale.
Pfizer (PFE) presentará avances significativos en los tratamientos para el cáncer genitourinario en el Simposio ASCO GU Cancers en San Francisco. La compañía mostrará más de 20 resúmenes, incluyendo cinco presentaciones orales, enfocándose en los cánceres de próstata y vejiga.
Los aspectos más destacados incluyen resultados detallados de supervivencia global del ensayo Fase 3 TALAPRO-2 con TALZENNA® con XTANDI® en cáncer de próstata resistente a la castración metastásica, que demostró mejoras estadísticamente significativas. Un análisis actualizado del ensayo Fase 3 EV-302 muestra beneficios sostenidos en la supervivencia global de PADCEV® combinado con pembrolizumab en cáncer urotelial avanzado.
La compañía también presentará los primeros datos de supervivencia libre de progresión aleatorizados para mevrometostat con XTANDI en mCRPC. El portafolio genitourinario de Pfizer incluye siete medicamentos aprobados para cánceres de vejiga, próstata y riñón, con la combinación TALZENNA-XTANDI ya aprobada en más de 35 países a nivel mundial.
화이자 (PFE)는 샌프란시스코에서 열리는 ASCO GU 암 심포지엄에서 비뇨생식기암 치료의 중요한 발전을 발표할 예정입니다. 이 회사는 전립선암과 방광암에 중점을 두고 5개의 구두 발표를 포함하여 20개 이상의 초록을 선보일 것입니다.
주요 하이라이트는 전이성 거세저항성 전립선암에서 TALZENNA® 및 XTANDI®의 3상 TALAPRO-2 시험의 통계적으로 유의미한 개선을 보여주는 전체 생존 결과입니다. 3상 EV-302 시험의 업데이트된 분석은 진행성 요로 상피암에서 PADCEV®와 펨브롤리주맙의 결합에 따른 지속적인 전체 생존 혜택을 보여줍니다.
회사는 또한 mCRPC에서 XTANDI와 함께 mevrometostat의 첫 번째 무작위 진행 없는 생존 데이터를 발표할 예정입니다. 화이자의 비뇨생식기 포트폴리오는 방광, 전립선 및 신장암을 위한 7개의 승인된 의약품을 포함하며, TALZENNA-XTANDI 조합은 전 세계 35개 이상의 국가에서 이미 승인되었습니다.
Pfizer (PFE) présentera des avancées significatives dans les traitements du cancer génito-urinaire lors du Symposium ASCO GU Cancers à San Francisco. L'entreprise présentera plus de 20 résumés, y compris cinq présentations orales, en se concentrant sur les cancers de la prostate et de la vessie.
Les points clés comprennent des résultats détaillés sur la survie globale de l'essai de Phase 3 TALAPRO-2 avec TALZENNA® et XTANDI® dans le cancer de la prostate résistant à la castration métastatique, qui a montré des améliorations statistiquement significatives. Une analyse actualisée de l'essai de Phase 3 EV-302 montre des bénéfices soutenus de survie globale pour PADCEV® associé à pembrolizumab dans le cancer urothélial avancé.
L'entreprise présentera également les premières données randomisées sur la survie sans progression pour mevrometostat avec XTANDI dans le mCRPC. Le portefeuille génito-urinaire de Pfizer comprend sept médicaments approuvés contre les cancers de la vessie, de la prostate et du rein, la combinaison TALZENNA-XTANDI étant déjà approuvée dans plus de 35 pays à travers le monde.
Pfizer (PFE) wird bedeutende Fortschritte bei der Behandlung von genitalen Krebsarten auf dem ASCO GU Cancers Symposium in San Francisco präsentieren. Das Unternehmen wird mehr als 20 Abstracts, einschließlich fünf mündlicher Präsentationen, zeigen, die sich auf Prostata- und Blasenkarzinome konzentrieren.
Zu den wichtigsten Ergebnissen gehören detaillierte Überlebensdaten aus der Phase-3-Studie TALAPRO-2 mit TALZENNA® und XTANDI® bei metastasiertem kastrationsresistentem Prostatakarzinom, die statistisch signifikante Verbesserungen zeigten. Die aktualisierte Analyse der Phase-3-Studie EV-302 zeigt anhaltende Überlebensvorteile von PADCEV® in Kombination mit Pembrolizumab bei fortgeschrittenem urotelialem Krebs.
Das Unternehmen wird auch die ersten randomisierten Daten zur progressionsfreien Überleben von mevrometostat in Kombination mit XTANDI bei mCRPC präsentieren. Das genitourinäre Portfolio von Pfizer umfasst sieben zugelassene Arzneimittel für Blasen-, Prostata- und Nierenkrebs, wobei die Kombination TALZENNA-XTANDI bereits in über 35 Ländern weltweit zugelassen ist.
- Phase 3 TALAPRO-2 trial showed statistically significant and clinically meaningful OS improvement
- TALZENNA-XTANDI combination approved in over 35 countries
- Strong portfolio of seven approved medicines across genitourinary cancers
- Phase 3 EV-302 study demonstrated sustained efficacy benefits
- Positive progression in pipeline development with mevrometostat
- None.
Insights
Pfizer's upcoming ASCO GU presentations reveal compelling developments across their oncology portfolio, with several potentially market-moving catalysts:
TALZENNA + XTANDI Combination: The detailed overall survival data from TALAPRO-2 could significantly strengthen the combination's market position in mCRPC. With approvals in 35+ countries already secured, positive OS data could expand label indications and drive increased adoption. This combination represents a important growth driver for Pfizer's oncology segment.
PADCEV Development: The updated EV-302 analysis showing sustained overall survival benefit in bladder cancer reinforces the combination's potential as a new standard of care. This positions Pfizer strongly in the first-line setting for locally advanced/metastatic urothelial cancer, a substantial market opportunity.
Pipeline Advancement: The mevrometostat data is particularly noteworthy as it represents Pfizer's push into novel mechanisms of action. The initiation of multiple Phase 3 trials in 2024 and planned expansion into first-line mCSPC demonstrates aggressive development strategy. The EZH2 inhibitor mechanism could provide differentiation in an increasingly competitive space.
The breadth of data across modalities - from small molecules to antibody-drug conjugates - showcases Pfizer's comprehensive approach to oncology development. This diversification helps mitigate clinical and commercial risks while maximizing market opportunities.
The clinical implications of these results are substantial for both prostate and bladder cancer treatment paradigms:
Prostate Cancer Advances: The TALAPRO-2 trial's statistically significant OS improvement in both all-comers and HRR-mutated populations could reshape treatment algorithms. This is particularly important as it demonstrates benefit regardless of biomarker status, while potentially offering enhanced efficacy in molecularly-defined populations.
Bladder Cancer Innovation: The sustained OS benefit from PADCEV + pembrolizumab in the EV-302 trial represents a significant advancement over traditional chemotherapy. The combination's consistent efficacy profile supports its positioning as a preferred first-line option, potentially improving outcomes for a broader patient population.
Pipeline Potential: The development of disitamab vedotin for HER2-expressing MIBC and sasanlimab for NMIBC addresses critical unmet needs in bladder cancer treatment. The positive early data suggests potential for these agents to expand treatment options across different disease stages and molecular subtypes.
- More than 20 abstracts span Pfizer’s leading genitourinary cancer portfolio of approved standards of care and growing pipeline across prostate and bladder cancers
- Detailed overall survival (OS) results from the pivotal Phase 3 TALAPRO-2 trial of TALZENNA® in combination with XTANDI® in patients with metastatic castration-resistant prostate cancer (mCRPC)
- Updated analysis from the Phase 3 EV-302 trial highlights sustained OS benefit of PADCEV® in combination with pembrolizumab in locally advanced or metastatic urothelial cancer
- First randomized progression-free survival (PFS) data for mevrometostat in combination with XTANDI in mCRPC
“Our long-standing commitment to the genitourinary cancer community has been foundational in our mission to transform the treatment landscapes for patients with bladder and prostate cancers,” said Karin Tollefson, Chief Oncology Medical Officer, Pfizer. “Our strong presence at this year’s ASCO GU highlights the longer-term impacts of our approved leading medicines for patients in their respective indications. We are also looking forward to sharing updates from our rapidly growing pipeline of novel targets and combination approaches, which have the potential to help address the diverse needs of patients across various stages of disease.”
Pfizer’s GU portfolio includes seven approved medicines across bladder, prostate, and kidney cancers, as well as a growing late-stage pipeline of scientific modalities and combination approaches. Key Pfizer presentations at ASCO GU include the detailed overall survival (OS) results from the Phase 3 TALAPRO-2 trial with TALZENNA® (talazoparib) plus XTANDI® (enzalutamide) in patients with metastatic castration-resistant prostate cancer (mCRPC), which will be featured in ASCO GU’s official Press Program. In addition, updated analysis from the Phase 3 global EV-302 study of PADCEV® (enfortumab vedotin-ejfv) in combination with pembrolizumab in locally advanced or metastatic urothelial cancer (la/mUC) will be presented, highlighting the long-term efficacy benefits of the combination.
From the pipeline, the first randomized progression-free survival (PFS) data from the ongoing Phase 1 dose-escalation study for mevrometostat plus XTANDI reinforce the potential of this investigational combination for patients with mCRPC. Additional pipeline presentations include updated data and real-world evidence for different types of bladder cancer, supporting the development of two potential transformative treatments, disitamab vedotin, an investigational antibody-drug conjugate (ADC), and sasanlimab, an investigational subcutaneous PD-1 blocker.
Key ASCO GU Presentations
Prostate Cancer
- TALZENNA plus XTANDI: Oral and poster presentations from the pivotal Phase 3 TALAPRO-2 trial of TALZENNA in combination with XTANDI will provide detailed results on the statistically significant and clinically meaningful improvement in OS in all-comers (cohort 1) as well as in those patients with homologous recombination repair (HRR) gene-mutated mCRPC (cohort 2), compared to XTANDI alone. TALZENNA in combination with XTANDI has been approved for use in over 35 countries globally for patients with certain types of mCRPC*. The OS results will be shared with global health authorities to potentially update the TALZENNA label.
- XTANDI: Six abstracts continue to underscore the benefit of XTANDI across its approved indications, including two posters highlighting follow-up analysis from the EMBARK trial of XTANDI in combination with leuprolide in patients with non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high-risk for metastasis.
- Mevrometostat: The first randomized PFS results from the ongoing Phase 1 dose-expansion study examine the potential of mevrometostat (PF-06821497), an investigational selective inhibitor of enhancer of zeste homolog 2 (EZH2), in combination with XTANDI in patients with mCRPC, compared to XTANDI alone. Pfizer initiated two pivotal Phase 3 trials for mevrometostat plus XTANDI in 2024 and expects to start a Phase 3 study of mevrometostat plus XTANDI in first-line mCSPC during the first half of 2025.
Bladder Cancer
- PADCEV: Long-term follow-up data from the groundbreaking Phase 3 EV-302 study of PADCEV in combination with pembrolizumab, including OS and safety data, continue to demonstrate consistent efficacy versus chemotherapy in a broad population, reinforcing the combination as standard of care in first-line treatment of la/muC.
- Disitamab vedotin: Updated efficacy and safety data from an ongoing Phase 2 study (sponsored by Remegen) evaluating the HER2-targeting ADC disitamab vedotin plus toripalimab show encouraging results as a perioperative regimen in HER2-expressing muscle-invasive bladder cancer (MIBC). These data add to the growing body of evidence supporting the continued development of disitamab vedotin across stages of bladder cancer.
- Sasanlimab: Three real-world evidence poster presentations highlight the need for advanced treatment options for patients with non-muscle invasive bladder cancer (NMIBC), including presentations on Bacillus Calmette-Guérin (BCG) treatment patterns, impact of BCG shortages, and outcomes and treatment patterns in patients with high-risk NMIBC. Pfizer recently reported positive topline results for sasanlimab in combination with BCG as induction therapy with or without maintenance in patients with BCG- naïve, high-risk NMIBC. Detailed results from the Phase 3 CREST trial will be presented at an upcoming congress.
Additional information on key Pfizer-sponsored abstracts at ASCO GU 2025, including date and time of presentation, follow in the chart below. A complete list of Pfizer-sponsored accepted abstracts is available here.
*TALZENNA in combination with XTANDI was approved by the
Prostate Cancer |
Final overall survival (OS) with talazoparib (TALA) + enzalutamide (ENZA) as first-line treatment in unselected patients with metastatic castration-resistant prostate cancer (mCRPC) in the Phase 3 TALAPRO-2 trial (Abstract #LBA18)
Agarwal, N
Oral Abstract Session Thursday, February 13, 11:42 AM – 11:52 AM EST Presentation Time: 8:42 AM – 8:52 AM PST |
Final overall survival (OS) with talazoparib (TALA) + enzalutamide (ENZA) as first-line (1L) treatment in patients (pts) with homologous recombination repair (HRR)-deficient metastatic castration-resistant prostate cancer (mCRPC) in the Phase 3 TALAPRO-2 trial (Abstract #LBA141)
Fizazi, K
Poster Session Thursday, February 13, 2:25 PM – 3:45 PM EST Presentation Time: 11:25 AM – 12:45 PM PST |
Mevrometostat (PF-06821497), an enhancer of zeste homolog 2 (EZH2) inhibitor, in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC): A randomized dose-expansion study (Abstract #LBA138)
Schweizer, MT
Rapid Oral Abstract Session Thursday, February 13, 8:25 PM – 8:30 PM EST Presentation Time: 5:25 PM – 5:30 PM PST |
Bladder Cancer |
EV-302: Updated analysis from the phase 3 global study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC) (Abstract #664)
Powles, TB
Rapid Oral Abstract Session Friday, February 14, 7:10 PM – 7:15 PM EST Presentation Time: 4:10 PM – 4:15 PM PST |
Neoadjuvant treatment with disitamab vedotin plus perioperative toripalimab in patients with muscle-invasive bladder cancer (MIBC) with HER2 expression: Updated efficacy and safety results from the phase II RC48-C017 trial (Abstract #665)
Sheng, X
Oral Abstract Session Friday, February 14, 11:57 AM – 12:07 PM EST Presentation Time: 8:57 AM – 9:07 AM PST |
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 bispecific 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.
Prescribing Information for Pfizer Medicines
Please read full Prescribing Information for TALZENNA® (talazoparib)
Please read full Prescribing Information for XTANDI® (enzalutamide)
Please read full Prescribing Information, including BOXED WARNING, for PADCEV® (enfortumab vedotin-ejfv)
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Disclosure notice
The information contained in this release is as of January 28, 2025. Pfizer 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 pipeline, in-line products and product candidates, including XTANDI® (enzalutamide), TALZENNA® (talazoparib), PADCEV® (enfortumab vedotin-ejfv), mevrometostat, disitamab vedotin and sasanlimab, including their potential benefits, 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 products and product candidates; 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 applications may be filed with any regulatory authorities 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; 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, 2023, 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
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