Tempest Therapeutics Inc. (TPST) has received positive feedback from the Food and Drug Administration (FDA) regarding its amezalpat (TPST-1120) drug candidate. The FDA has given the green light for a Phase 3 clinical trial evaluating amezalpat in combination with atezolizumab (Tecentriq, sold by Roche Holding AG’s Genentech) and bevacizumab (Avastin, also sold by Genentech) to treat first-line unresectable or metastatic hepatocellular carcinoma (HCC).
The FDA and Tempest Therapeutics are in agreement on all key aspects of the proposed Phase 3 study. The trial will closely mirror the successful Phase 2 study, which showed promising results in terms of overall survival. This positive outcome has fueled confidence in the potential success of the Phase 3 trial.
Key outcomes of the FDA meeting include:
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Agreement on Phase 3 study design:
This includes the standard-of-care control arm and the primary and secondary study endpoints.*
Agreement on dosing:
The current amezalpat dose and the Phase 3 study schedule have been deemed appropriate.*
Agreement on statistical plan:
The Phase 3 study will incorporate a pre-specified early efficacy analysis, potentially shortening the time to primary analysis by up to eight months.The planned Phase 3 trial is a global, blinded, 1:1 randomized study that will compare amezalpat plus atezolizumab and bevacizumab to the standard-of-care treatment of atezolizumab and bevacizumab in patients with unresectable or metastatic HCC. The company aims to initiate the Phase 3 study in the first quarter of 2025.
Following the news, TPST stock saw a significant surge, closing at $1.61 on Thursday, representing a 34.90% increase.
This development is a positive step for Tempest Therapeutics and the fight against liver cancer. The successful completion of the Phase 3 trial could lead to a new treatment option for patients with this challenging disease.
