Pfizer, Astellas: PADCEV Plus KEYTRUDA Shows Long-Term Efficacy In EV-302 Trial In La/mUC Patients

(RTTNews) - Drug major Pfizer Inc. (PFE) and Japan's Astellas Pharma Inc. announced late Monday additional follow-up results from the Phase 3 EV-302 clinical trial, also known as KEYNOTE-A39, evaluating the efficacy and safety of PADCEV (enfortumab vedotin-ejfv) plus KEYTRUDA (pembrolizumab) in patients with previously untreated locally advanced or metastatic urothelial cancer or la/mUC.

The trial results showed a sustained overall survival or OS and progression-free survival or PFS benefit, which was consistent with the findings of the primary analysis after an additional 12 months of follow-up (median follow-up of 29.1 months).

Seagen's and Astellas' PADCEV is a Nectin-4 directed antibody-drug conjugate, while Merck's KEYTRUDA is a PD-1 inhibitor.

Seagen, which was acquired by Pfizer, and Astellas are in clinical collaboration deal with Merck to evaluate the combination of PADCEV and KEYTRUDA in patients with previously untreated metastatic urothelial cancer.

The EV-302 trial is an open-label, randomized, controlled Phase 3 study, evaluating enfortumab vedotin in combination with pembrolizumab versus platinum-containing chemotherapy in patients with previously untreated la/mUC.

The study enrolled 886 patients with previously untreated la/mUC who were eligible for cisplatin- or carboplatin-containing chemotherapy regardless of PD-L1 status.

Results showed enfortumab vedotin plus pembrolizumab reduced the risk of death by 49% versus chemotherapy. The median OS was 33.8 months for the combination versus 15.9 months for chemotherapy, and the median PFS was 12.5 months for the combination versus 6.3 months for chemotherapy.

The companies plan to present the data during a rapid oral session at the American Society of Clinical Oncology Genitourinary Cancers Symposium 2025 in San Francisco, CA, on February 14.

Primary results from the EV-302 study were presented at the European Society for Medical Oncology (ESMO) Congress in October 2023.

Thomas Powles, EV-302 Primary Investigator, said, "These latest findings from the EV-302 trial reaffirm the primary results, which demonstrated survival improvements for patients treated with enfortumab vedotin and pembrolizumab that were previously unprecedented in locally advanced or metastatic urothelial cancer. These data show that the potential survival benefit has become even more robust with extended follow up and further solidify the combination as standard of care."

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