Pfizer, Astellas Report Positive Phase 3 Trial Results for PADCEV Combination in Bladder Cancer Treatment

By Maham Fatima | January 08, 2026, 9:13 AM

Pfizer Inc. (NYSE:PFE) is one of the most buzzing stocks to invest in according to hedge funds. Earlier on December 17, Astellas Pharma and Pfizer Inc. (NYSE:PFE) announced positive topline results from the Phase 3 EV-304 clinical trial (also called KEYNOTE-B15). This study showed that the combination of PADCEV (enfortumab vedotin) and Keytruda (pembrolizumab) improves survival outcomes for patients with muscle-invasive bladder cancer/MIBC who are eligible for cisplatin-based chemotherapy.

Used as a perioperative treatment, meaning both before and after surgery, this regimen is the first platinum-free therapy to show significant improvements in both Event-Free Survival and Overall Survival compared to the current standard of care, which relies on gemcitabine and cisplatin chemotherapy. The trial also met a key secondary endpoint by showing a significant improvement in the pathologic complete response rate.

Pfizer, Astellas Report Positive Phase 3 Trial Results for PADCEV Combination in Bladder Cancer Treatment

Currently, bladder cancer is the ninth most common cancer globally, with over 614,000 annual diagnoses, including 85,000 in the US. ~30% of these cases are classified as MIBC. While the standard treatment has long been cisplatin-based chemotherapy followed by surgery, ~50% of patients still experience disease recurrence or progression to metastatic disease within 3 years.

PADCEV is a first-in-class antibody-drug conjugate that targets Nectin-4, which is a protein highly expressed in bladder cancer cells. It works by delivering a cell-killing agent, monomethyl auristatin E, directly into the cancer cells to trigger apoptosis.

Pfizer Inc. (NYSE:PFE) discovers, develops, manufactures, markets, distributes, and sells biopharmaceutical products in the US and internationally.

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Disclosure: None. This article is originally published at Insider Monkey.

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