Pfizer Inc and Astellas Pharma Inc have announced encouraging early results from the Phase 3 EV-303 (KEYNOTE-905) trial. The study evaluated PADCEV (enfortumab vedotin), an antibody-drug conjugate targeting Nectin-4, in combination with KEYTRUDA (pembrolizumab), a PD-1 inhibitor. This combination was tested before and after surgery in patients with muscle-invasive bladder cancer who are unable to receive cisplatin, comparing it with the current standard of surgery alone.
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At the initial analysis, the PADCEV and KEYTRUDA combination significantly improved event-free survival (EFS), which is the primary endpoint of the trial. The combination also showed benefits in overall survival (OS), which was one of the key secondary goals. Additionally, the trial met another secondary endpoint by demonstrating a higher rate of pathologic complete response (pCR), suggesting a deeper tumor response prior to surgery.
“Patients with muscle-invasive bladder cancer who can’t receive cisplatin have not had significant treatment advances in decades. Even after bladder removal, the risk of the disease returning remains high, with a generally poor prognosis. These EV-303 results show that a treatment strategy applied before and after surgery can meaningfully extend survival over surgery alone, which is a major step forward for this group of patients,” said Christof Vulsteke, M.D., Ph.D., head of Integrated Cancer Center Ghent and the trial’s principal investigator.
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The trial is ongoing, with additional data on EFS, OS, and pCR continuing to mature over time. The safety findings so far are consistent with what has previously been seen for each individual therapy. Moitreyee Chatterjee-Kishore, Ph.D., M.B.A., head of Oncology Development at Astellas, said, “These results from EV-303 are a breakthrough for cisplatin-ineligible patients with muscle-invasive bladder cancer, showing that PADCEV in combination with KEYTRUDA could become a new standard of care when used before and after surgery. We look forward to sharing more details about these findings at an upcoming medical conference.”
Muscle-invasive bladder cancer makes up around 30 percent of the more than 614,000 bladder cancer cases diagnosed each year globally. While cisplatin-based chemotherapy followed by surgery has been the standard of care for eligible patients, many people with MIBC are not able to tolerate cisplatin. As a result, they often have to undergo surgery alone, which limits their treatment options and affects long-term outcomes. Johanna Bendell, M.D., Oncology Chief Development Officer at Pfizer, noted, “PADCEV plus KEYTRUDA has already changed the treatment approach for patients with locally advanced or metastatic urothelial cancer. These new results show the potential for this combination to improve care even earlier in the disease process. We are deeply grateful to the patients and investigators who contributed to this trial.”
The data from this study will be presented at an upcoming medical congress and submitted to health authorities for potential regulatory approval. A related Phase 3 trial, EV-304 (KEYNOTE-B15), is also underway to evaluate this combination in cisplatin-eligible patients. The EV-303 trial remains active and is designed to assess how PADCEV and KEYTRUDA perform together in terms of event-free survival, overall survival, and pathologic complete response compared to surgery alone or KEYTRUDA alone in patients who cannot receive cisplatin-based chemotherapy.
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