Bristol Myers Squibb announced that CheckMate -274, a pivotal Phase 3 trial evaluating Opdivo (nivolumab) after surgery in patients with high-risk, muscle-invasive urothelial carcinoma, met primary endpoints of improving disease-free survival (DFS) versus placebo in both all randomized patients and in patients whose tumor cells express PD-L1 ≥1% (programmed death-ligand 1).
The U.S. Food and Drug Administration approved Bavencio (avelumab) for maintenance treatment of locally advanced or metastatic urothelial carcinoma that has not progressed after first-line platinum-containing chemotherapy.
Merck’s checkpoint inhibitor Keytruda (pembrolizumab) did not meet the pre-specified dual primary endpoints in a study of the drug in combination with chemotherapy for the first-line treatment of advanced or metastatic urothelial carcinoma.
Pfizer and EMD Serono – the biopharmaceutical unit of Darmstadt, Germany-based Merck KGaA – announced that the companies’ Phase III JAVELIN Bladder 100 trial hits the primary endpoint of overall survival (OS) at a planned interim analysis.
Humira’s dominance continues as the world’s top-selling prescription product as the biologic therapy is the first drug to exceed $20 billion in annual global sales.
Seattle Genetics and Tokyo-based Astellas Pharma announced positive top-line data from the first cohort of the Phase II EV-201 trial evaluating enfortumab vedotin in patients with locally advanced or metastatic urothelial cancer who had previously received both platinum-based chemotherapy and a checkpoint inhibitor.
Checkmate Pharmaceuticals announced a clinical trial collaboration and supply agreement with the alliance between Merck KGaA and Pfizer Inc. to evaluate the TLR9 agonist CMP-001 in combination with the human anti-PD-L1 antibodyavelumab.