Amezalpat With Atezolizumab, Bevacizumab Gains Positive Approval From FDA for Phase 3 Trial

Tempest, a pharmaceutical company, announced that a recent end-of-phase 2 meeting with the US Food and Drug Administration garnered positive feedback for amezalpat with atezolizumab and bevacizumab for the treatment of first-line unresectable or metastatic hepatocellular carcinoma (HCC).

Phase 3 of the TPST-1120-301 study plans to compare the triplet combination with atezolizumab and bevacizumab in this patient population.

A top-line analysis of phase 2 of the study found that the treatment had a favorable hazard ratio (HR) for overall survival (OS).

As atezolizumab and bevacizumab is a common standard-of-care treatment for HCC, the ongoing phase 1b/2 of the study examined amezalpat, an oral selective PPAR⍺ antagonist that modulates immune suppressive cells and angiogenesis in the tumor microenvironment, in combination with the doublet, which showed clinical superiority when compared with atezolizumab and bevacizumab alone.

Chief Medical Officer and Head of Research and Development at Tempest, Sam Whiting, MD, PhD, remarked that the “planned phase 3 study closely mirrors the randomized phase 2 study, and the strongly favorable [HR for OS] observed at top-line analysis of phase 2, confirmed at the latest survival follow-up, gives us confidence in the potential success of phase 3.”

Phase 3 of the study is set to begin in the first quarter of 2025.