Phase III JAVELIN Bladder 100 study met its primary endpoint to treat urothelial carcinoma .- Merck KGaA + Pfizer
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Astellas Pharma Inc. and Seagen Inc. announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer (la/mUC) who received prior treatment with a PD-1/L1 inhibitor and platinum-based chemotherapy.
Pembrolizumab monotherapy led notable antitumor activity with manageable toxicity in patients with Bacillus Calmette-Guérin (BCG)–unresponsive, papillary high-risk non–muscle-invasive bladder cancer (NMIBC), according to findings from cohort B of the phase II Keynote-057 trial (NCT02625961) that were presented at the 2023 Genitourinary Cancers Symposium.
Bristol Myers Squibb announced three-year follow-up results from the Phase III CheckMate -274 trial, demonstrating significant sustained clinical benefits with Opdivo (nivolumab) for the adjuvant treatment of patients with surgically resected, high-risk muscle-invasive urothelial carcinoma.