On Thursday, Tempest Therapeutics Inc. (NASDAQ:TPST) announced feedback from its end-of-Phase 2 meeting with the FDA for amezalpat (TPST-1120) in combination with atezolizumab and bevacizumab to treat first-line unresectable or metastatic hepatocellular carcinoma (HCC).
Roche Holding AG's (OTC:RHHBY) Genentech sells bevacizumab as Avastin and atezolizumab as Tecentriq.
"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 topline analysis of Phase 2, confirmed at the latest survival follow-up, gives us confidence in the potential success of Phase 3," said Sam Whiting, chief medical officer and head of R&D.
Also Read: What's Going On With Cancer-Focused Tempest Therapeutics Stock On Thursday?
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 endpoints.
- Agreement on the appropriateness of the current amezalpat dose and the Phase 3 study schedule.
- Agreement 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.
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.
Price Action: TPST stock is up 34.90% at $1.61 at the last check on Thursday.
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