BioCentury
ARTICLE | Regulation

April 14 Quick Takes: GSK stops two trials of ICOS agonist; plus Trodelvy, Amylyx, Junshi, Jazz, MitoChem

April 15, 2021 1:19 AM UTC

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said it is discontinuing treatment with ICOS agonist feladilimab (GSK3359609) in two Phase II trials for metastatic head and neck squamous cell carcinoma following a recommendation by the independent data monitoring committee to stop the INDUCE-3 trial. It did not specify a reason. INDUCE-3 is assessing the therapy with pembrolizumab vs. placebo plus pembrolizumab in PD-L1-positive recurrent locally advanced or metastatic head and neck squamous cell carcinoma. The other study, INDUCE-4, was evaluating feladilimab vs. placebo in combination with pembrolizumab and chemotherapy. GSK is partnered with Merck & Co. Inc. (NYSE:MRK) on the therapy. 

FDA expanded the label for Trodelvy sacituzumab govitecan-hziy from Gilead Sciences Inc. (NASDAQ:GILD), granting the therapy accelerated approval to treat locally advanced or metastatic urothelial cancer. Last week, Trodelvy gained full approval in the U.S. for triple-negative breast cancer. The latest approval is for adults who have previously received a platinum-containing chemotherapy and either a PD-1 or a PD-L1 inhibitor. Gilead gained the antibody-drug conjugate via its $21 billion acquisition of Immunomedics Inc. in October. ...