eClinical Technology and Industy News

Tempest Unveils New Survival Data for Amezalpat (TPST-1120) in Randomized First-Line HCC Study Demonstrating a Six-Month Improvement over Control Arm

  • 21 months median OS in amezalpat arm vs. 15 in control arm 50% (20/40) of patients on amezalpat arm remain in survival follow up
  • 0.65 hazard ratio, maintained since 0.59 observed in primary analysis 10 months earlier Early and persistent separation of survival curves
  • OS is the primary regulatory endpoint for first-line HCC

Excerpt from the Press Release:

BRISBANE, Calif., June 20, 2024 (GLOBE NEWSWIRE) — Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing first-in-class1 therapeutics that combine both targeted and immune-mediated mechanisms, today announced new positive data from the ongoing global randomized Phase 1b/2 clinical study in which amezalpat2 (TPST-1120), Tempest’s PPAR⍺ antagonist, delivered a six-month improvement in median overall survival (“OS”) advantage when combined with atezolizumab and bevacizumab in a comparison to atezolizumab and bevacizumab alone in the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma (“HCC”).

“We are thrilled by these new survival data that build on the already meaningful data released in the fall showing the improvement of the amezalpat arm over atezolizumab and bevacizumab control across all study endpoints,” said Stephen Brady, president and chief executive officer of Tempest. “These new data come after 10 more months of follow-up since the last data analysis and show not only a strong hazard ratio of 0.65 favoring the amezalpat arm, but also a six-month improvement in the median overall survival with half the patients still in survival follow up, as well as observation of a survival advantage across key populations – results that we believe put amezalpat in a strong position for a successful pivotal Phase 3.”

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