Tempest receives FDA study may proceed for Phase 3 trial of amezalpat

Tempest Therapeutics (TPST) announced that the company received a “Study May Proceed” letter from the U.S. Food and Drug Administration, FDA, to evaluate amezalpat, TPST-1120, in combination with atezolizumab and bevacizumab, the current standard of care, versus the standard of care alone in a pivotal randomized Phase 3 trial for the first-line treatment of unresectable or metastatic hepatocellular carcinoma, HCC. “The clinical and regulatory team at Tempest are thrilled to receive this notice from FDA with respect to the planned pivotal Phase 3 trial to evaluate amezalpat as a potential treatment for first-line liver cancer,” said Sam Whiting M.D., Ph.D., chief medical officer and head of R&D of Tempest. “Previously reported positive Phase 2 data underscore amezalpat’s potential to improve the survival of patients facing this life-threatening disease, and our team is dedicated to advancing the program and bringing amezalpat to patients.”