Bristol Myers Squibb shared the news that the company’s Phase III clinical trial investigating the safety and efficacy of Opdivo and Yervoy combination therapy (NCT03036098) in patients with metastatic urothelial carcinoma failed to meet the predetermined primary endpoint. A posthoc analysis was shared by Synairgen suggesting that, despite SNG001 failing to meet the primary endpoint of patient recovery and subsequent hospital discharge in a Phase III study for patients hospitalized with COVID-19 who required supplemental oxygen treatment, they may benefit from receiving the treatment.
Nektar Therapeutics said on April 14 the company had stopped all clinical trials involving the drug developer’s key cancer drug bempegaldesleukin following its failure in multiple studies, dragging Nektar shares down 23% in after-market trading.
The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) to Merck for the company’s supplemental Biologics License Application for Keytruda (pembrolizumab) in high-risk early-stage triple-negative breast cancer.
Two weeks after AstraZeneca announced the company was withdrawing the use of Imfinzi as a treatment for bladder cancer in the United States, Swiss pharma giant Roche followed suit with the checkpoint inhibitor Tecentriq (atezolizumab).
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.