Pembrolizumab plus enfortumab vedotin improves survival in advanced bladder cancer
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The combination of pembrolizumab plus enfortumab vedotin significantly extended OS and PFS as first-line treatment for adults with locally advanced or metastatic urothelial carcinoma, according to the manufacturers of both agents.
Results from the phase 3 KEYNOTE-A39/EV-302 trial showed the study met its dual primary endpoints, as the combination significantly improved OS and PFS compared with chemotherapy in patients with previously untreated locally advanced or metastatic urothelial cancer. The study includes cohorts for both adults who are eligible and ineligible for cisplatin-containing chemotherapy.
The FDA previously granted accelerated approval to the combination of pembrolizumab (Keytruda, Merck) — a PD-1 inhibitor — and the antibody-drug conjugate enfortumab vedotin-ejfv (Padcev; Seagen, Astellas Pharma) as first-line treatment for cisplatin-ineligible adults with locally advanced or metastatic urothelial carcinoma.
The KEYNOTE-A39/EV-302 trial is intended to serve as the confirmatory trial to support the accelerated approval indication, according to a Merck-issued press release.
“This study has the potential to be practice changing and offer a new standard of care for first-line metastatic bladder cancer,” Roger Dansey, MD, president of research and development at Seagen, said in a company-issued press release. “We look forward to presenting the results at an upcoming medical conference and discussing with regulators in order to get this medicine to patients as soon as possible.”
The combination also demonstrated a statistically significant improvement in overall response rate compared with chemotherapy. The manufacturers reported no new safety signals, with treatment related-toxicities being consistent with previously reported studies using the combination therapy.
References:
- Merck announces phase 3 KEYNOTE-A39/EV-302 trial met dual primary endpoints of overall survival and progression-free survival in certain patients with previously untreated locally advanced or metastatic urothelial cancer (press release). Available at: https://www.merck.com/news/merck-announces-phase-3-keynote-a39-ev-302-trial-met-dual-primary-endpoints-of-overall-survival-os-and-progression-free-survival-pfs-in-certain-patients-with-previously-untreated-locally-advanced/. Published Sept. 22, 2023. Accessed Sept. 25, 2023.
- Padcev (enfortumab vedotin-ejfv) and Keytruda (pembrolizumab) significantly improve overall survival and progression-free survival in patients with previously untreated advanced bladder cancer in pivotal phase 3 EV-302 trial (press release). https://investor.seagen.com/press-releases/news-details/2023/PADCEV-enfortumab-vedotin-ejfv-and-KEYTRUDA-pembrolizumab-Significantly-Improve-Overall-Survival-and-Progression-Free-Survival-in-Patients-With-Previously-Untreated-Advanced-Bladder-Cancer-in-Pivotal-Phase-3-EV-302-Trial/default.aspx. Published Sept. 22, 2023. Accessed Sept. 25, 2023.
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