On November 12, 2024 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, reported 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) (Press release, Tempest Therapeutics, NOV 12, 2024, View Source [SID1234648216]).
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"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."
About the TPST-1120-301 Study (NCT06680258)
The planned Phase 3 study is a global, blinded, 1:1 randomized study of amezalpat plus atezolizumab and bevacizumab versus placebo plus atezolizumab and bevacizumab, the standard of care, for the first-line treatment of patients with unresectable or metastatic HCC. In August 2024, the company received agreement from the FDA on its Phase 3 study design, dose of amezalpat, and the statistical plan, including a pre-specified efficacy analysis that could shorten the time to primary analysis. The company is working to enable a Phase 3 study to start in the first quarter of 2025.
About Amezalpat
Amezalpat is an oral, small molecule, selective PPAR⍺ antagonist. Data suggest that amezalpat treats cancer by targeting tumor cells directly and by modulating immune suppressive cells and angiogenesis in the tumor microenvironment. In an ongoing global randomized phase 1b/2 study of amezalpat in combination with atezolizumab and bevacizumab in first-line patients with advanced HCC, the amezalpat arm showed clinical superiority across multiple study endpoints, including overall survival in both the entire population and key subpopulations, when compared to atezolizumab and bevacizumab alone, the standard of care. These randomized data were supported by additional positive results observed in the Phase 1 clinical trial in patients with heavily pretreated advanced solid tumors, including renal cell carcinoma and cholangiocarcinoma.