The Food and Drug Administration (FDA) has commenced a priority assessment of a novel combined treatment for previously untreated, advanced forms of urothelial carcinoma (UC), the predominant type of bladder cancer. This groundbreaking regimen involves MSD’s Keytruda and Astellas/Seagen’s Padcev. Expected by May 9th next year, the FDA will provide its decision on this combination, potentially offering an alternative to initial chemotherapy for all patients afflicted with this variant of cancer.
Padcev, an antibody-drug conjugate targeting Nectin-4, alongside Keytruda, a PD-1 inhibitor, has already received accelerated FDA approval as a primary treatment option for advanced UC among patients ineligible for chemotherapy. Should this combined therapy gain approval, it could expand its reach to a significantly larger population of patients eligible for chemotherapy, a notable shift.
In the United States alone, it’s estimated that over 82,000 individuals will receive a bladder cancer diagnosis this year, with UC accounting for 90% of these cases. Astellas has approximated a population of 8,000 to 9,000 UC patients in the US who are ineligible for cisplatin-based chemotherapy.
Keytruda/Padcev Duo Shows Remarkable Efficacy in Bladder Cancer
The application for approval is built on findings from the EV-302/KEYNOTE-A39 trial. This trial demonstrated that the duo reduced the risk of death by 53% compared to chemotherapy when utilized as the first-line treatment for locally advanced or metastatic UC. Patients treated with the combined therapy experienced a significant improvement in overall survival (OS) by more than 15 months, reaching 31.5 months compared to 16.1 months with chemotherapy. Additionally, the median progression-free survival (PFS) doubled, extending to 12.5 months from 6.3 months.
Ahsan Arozullah, Astellas’ head of oncology development, stressed the critical need for innovative therapies in this patient population, acknowledging that chemotherapy has remained the standard of care for over three decades. The commitment remains strong to provide advanced urothelial cancer patients with extended life expectancy.
However, the Keytruda/Padcev combination might encounter competition from a competing treatment regimen involving Bristol-Myers Squibb’s PD-1 inhibitor Opdivo administered alongside standard chemotherapy. This alternative demonstrated improvements in both OS and PFS in the recent CheckMate 901 trial, potentially offering a more cost-effective option than the Keytruda/Padcev combination.
Promising Advances in Bladder Cancer Treatment
Additionally, the upcoming NILE study evaluating AstraZeneca’s Imfinzi with chemotherapy or in combination with Imjudo, along with other combinations, may provide further insights into treatment efficacy in this setting, with results expected next year. Beyond this, MSD, Astellas, and Seagen are conducting additional trials on the Keytruda/Padcev combination in UC. This includes two phase 3 clinical trials focusing on earlier-stage muscle-invasive bladder cancer known as KEYNOTE-B15/EV-304 and KEYNOTE-905/EV-303.
The expedited FDA review of this innovative combination signifies a potential paradigm shift in the treatment landscape for advanced bladder cancer, offering renewed hope and prospects for enhanced patient outcomes.
Resource: Pharmaphorum, December 01, 2023
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