TSE:4503

Pfizer Inc. and Astellas Pharma Inc. said their Phase 3 EV-304 (KEYNOTE-B15) trial showed that PADCEV (enfortumab vedotin) plus Keytruda (pembrolizumab) significantly improved outcomes in cisplatin-eligible muscle-invasive bladder cancer (MIBC) patients when used before and after surgery.

The combination reduced the risk of recurrence, progression or death by 47% versus standard neoadjuvant gemcitabine and cisplatin (HR 0.53; p<.0001), with 79.4% of patients event-free at two years compared with 66.2% under standard care. Overall survival improved by 35% (HR 0.65; p=.0029), while 55.8% of patients achieved a pathological complete response at surgery, versus 32.5% in the chemotherapy arm.

Results were presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco. The companies said the platinum-free regimen could establish a new standard of care if approved. PADCEV plus pembrolizumab is already approved in the U.S. for perioperative treatment in cisplatin-ineligible MIBC patients.

Source: Business Wire
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Global Finance News 02-28-26
XTANDI Plus Leuprolide Significantly Extends Survival in High-Risk Prostate Cancer Patients, Pfizer and Astellas Report

New York & Tokyo, July 10, 2025 – Pfizer and Astellas announced that XTANDI (enzalutamide), in combination with leuprolide, significantly improved overall survival (OS) in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk biochemical recurrence (BCR), based on Phase 3 EMBARK trial results.

The combination therapy achieved a statistically significant and clinically meaningful OS benefit over placebo plus leuprolide, marking XTANDI as the first androgen receptor inhibitor regimen to do so in this patient population. A favorable OS trend was also observed with XTANDI monotherapy, although it did not reach statistical significance.

No new safety concerns emerged. Common side effects included hot flashes, fatigue, and gynecomastia, depending on the treatment group. The EMBARK trial previously demonstrated XTANDI’s benefit in metastasis-free survival (MFS), published in *The New England Journal of Medicine* in 2023.

XTANDI is now the only treatment shown to extend survival across multiple stages of advanced prostate cancer, including mHSPC, nmCRPC, and now nmHSPC with high-risk BCR. Detailed results will be presented at a future medical meeting.
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The Investor 07-10-25