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

• 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
• Company to host webcast conference call today at 8:30am ET

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."

At the cutoff date of February 14, 2024, the new data from 40 patients randomized to the amezalpat arm and 30 patients randomized to the control arm show:

• 21 month median OS for the amezalpat arm versus 15 month for the control arm, a six-month survival advantage
• 20/40 patients remain in survival follow up in the amezalpat arm, compared to 9/30 patients in the control arm
• 0.65 hazard ratio ("HR") for OS, revealing a stable HR since the top-line analysis 10 months earlier when the HR was 0.59
• Manageable safety profile consistent with Phase 1 data

The earlier top-line data analysis, dated April 20, 2023, had a median follow up of 9.2 and 9.9 months for the amezalpat and control arms, respectively, and showed:

• Confirmed objective response rate ("cORR" or "confirmed ORR") of 30% for the amezalpat arm versus 13.3% for the control arm;
• Biomarker subpopulation findings were consistent with the mechanism of action of amezalpat
  
  • Patients with b-catenin activating mutations (21% in this study (n=7)) showed a cORR of 43% and a disease control rate ("DCR") of 100% in the amezalpat arm
  • The amezalpat arm was consistently active across both PD-L1 positive and PD-L1 negative ...

Full story available on Benzinga.com