Tempest Secures FDA Approval to Move Forward With Pivotal Phase 3 Trial For Amezalpat In Liver Cancer

Tempest Therapeutics, Inc., a biotechnology firm focused on pioneering cancer therapies, today announced it has received a “Study May Proceed” letter from the U.S. Food and Drug Administration (FDA) to advance with a Phase 3 trial. The study will assess amezalpat (TPST-1120), combined with atezolizumab and bevacizumab standard treatments currently used independently compared to the standard care alone. This pivotal trial will investigate the efficacy of this combination as a first-line therapy for patients with unresectable or metastatic hepatocellular carcinoma (HCC).

Sam Whiting, M.D., PhD, Chief Medical Officer and Head of R&D of Tempest, said in a statement, “The clinical and regulatory team at Tempest are thrilled to receive this notice from the FDA concerning the planned pivotal Phase 3 trial to evaluate amezalpat as a potential treatment for first-line liver cancer. 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.”