A Phase III study testing Keytruda monotherapy in second-line esophageal cancer versus physician’s choice of chemotherapy shows a 31% reduction in risk of death for patients expressing PD-L1. [Editor's Note: Article updated to clarify trial outcomes.]
Merck & Co. Inc. plans to seek supplemental approval for its anti-PD-1 therapy Keytruda in second-line esophageal cancer based on successful data from a Phase III study testing pembrolizumab monotherapy versus physician’s choice of chemotherapy, after the trial showed statistical significance in improving overall survival in patients whose tumors express PD-L1.
The trial was designed to be deemed successful if it proved any of three primary hypotheses pertaining to overall survival...
Set to merge with Beckley Psytech, Atai will focus on psychedelic candidates for treatment-resistant depression while Recognify will analyze Phase IIb data for possible next steps.
The biotech announced positive results in the PIK3CA wild-type population in second-line HR+/HER2- breast cancer for its PAM inhibitor.
The trontinemab Phase III study is due to get underway this year, with Roche confident its brainshuttle technology will help it surpass approved rivals.
Comes Days After PDUFA Pushback For GSK's Blenrep.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
Chief Medical Officer Samit Hirawat will step down to pursue new career opportunities, the company said.
The privately held German pharma firm is hoping to bring a new generation of pulmonary fibrosis and cancer drugs to market but their commercial success is not yet a certainty.
