Summit Therapeutics provides update regarding ivonescimab biologics license application
SMMT•SMMT•SMMT•SMMT•Summit Therapeutics said the FDA cannot approve ivonescimab’s biologics license application because of a lack of statistically significant overall survival improvement. The Phase III HARMONi study showed statistically significant progression-free survival improvement, and the combination with chemotherapy had an acceptable safety profile.
Summit Therapeutics said the FDA cannot approve ivonescimab’s biologics license application due to a lack of statistically significant overall survival improvement. The company said its Phase III HARMONi study showed statistically significant progression-free survival improvement, and ivonescimab plus chemotherapy demonstrated an acceptable safety profile.
Summit is developing ivonescimab in non-small cell lung cancer, colorectal cancer, urothelial carcinoma and renal cell carcinoma through Phase II and Phase III trials. The company collaborates with AstraZeneca and Daiichi Sankyo on ivonescimab combinations.
