Merck's KEYTRUDA and Padcev Approved by FDA for Bladder Cancer Treatment

FDA Approval

The U.S. FDA has approved KEYTRUDA (pembrolizumab) and KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) in combination with Padcev (enfortumab vedotin-ejfv) for treating adults with muscle-invasive bladder cancer (MIBC) who cannot undergo cisplatin-based chemotherapy. This marks the first approval of PD-1 inhibitor plus ADC regimens for this patient group.

Clinical Trial Data

The approval is based on data from the Phase 3 KEYNOTE-905 trial, also known as EV-303, conducted in collaboration with Pfizer and Astellas. The trial results were presented at the European Society for Medical Oncology (ESMO) Congress.

Significant Findings

After a median follow-up of 25.6 months, the combination of KEYTRUDA and Padcev as perioperative treatment showed a statistically significant 60% reduction in the risk of event-free survival (EFS) events compared to surgery alone. The hazard ratio was 0.40 with a 95% confidence interval of 0.28-0.57, and the p-value was less than 0.0001.

Outcome Metrics

In the trial, 28% of patients receiving the combination treatment experienced EFS events, compared to 55% in the surgery-alone group. The median EFS was not reached in the treatment group, with a 95% confidence interval of 37.3 months to not reached, while the surgery-alone group had a median EFS of 15.7 months, with a 95% confidence interval of 10.3 to 20.5 months.