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Tempest Announces Successful End-of-Phase 2 Meeting with FDA for Amezalpat (TPST-1120) to Treat First-Line Hepatocellular Carcinoma
Broad agreement on pivotal Phase 3 study plan, including use of current amezalpat dose and scheduleOverall survival, the strongest result from the Phase 2
About this update from Tempest Therapeutics, Inc.
[{"type":"text","content":"Broad agreement on pivotal Phase 3 study plan, including use of current amezalpat dose and scheduleOverall survival, the strongest result from the Phase 2 trial, will be the primary study endpointAgreed-upon early efficacy analysis could reduce time to primary read-out significantly BRISBANE, Calif., Aug. 15, 2024 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, today announced positive feedback from its end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for amezalpat (TPST-1120) in combination with atezolizumab and bevacizumab to treat first-line unresectable or metastatic hepatocellular carcinoma (HCC). \"We are thrilled with the positive outcome of our end-of-Phase 2 meeting with the FDA,” said Sam Whiting, M.D., Ph.D., chief medical officer and head of R&D at Tempest. “Tempest and the FDA are in broad agreement on all major aspects of the proposed pivotal Phase 3 clinical trial for amezalpat in patients with hepatocellular carcinoma in the first line setting. This planned Phase 3 study closely mirrors the randomized Phase 2 study and the strongly favorable hazard ratio for overall survival observed at top-line analysis of the Phase 2, confirmed at the latest survival follow-up, give us confidence in the potential success of the Phase 3.” Key outcomes of the FDA meeting include: Agreement on Phase 3 study design, including the standard-of-care control arm and the primary and secondary study endpointsAgreement on appropriateness of the current amezalpat dose and schedule for the Phase 3 studyAgreement on the Phase 3 statistical plan including a pre-specified early efficacy analysis that the company currently estimates could shorten the time to primary analysis by up to 8 months About the TPST-1120-301 Study The planned Phase 3 study is a global, blinded, 1:1 randomized study of amezalpat plus atezolizumab and bevacizumab vs. atezolizumab and bevacizumab, the standard of care, in patients with unresectable or metastatic HCC treated in the first line setting. The company is preparing for the Phase 3 study start in the first quarter of 2025. About Amezalpat (TPST-1120) Amezalpat is an oral, small molecule, selective PPAR⍺ antagonist. Tempest’s data suggest that amezalpat t...