Tempest Therapeutics, Inc. announced positive early results from a global randomized Phase 1b/2 clinical study in which TPST-1120, Tempest's small molecule PPAR antagonist, demonstrated clinically-meaningful improvement in multiple categories when combined with the standard-of-care regimen of atezolizumab and bevacizumab in a randomized comparison to atezolizumab & bevacizumab In the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC). Data from 40 patients in the TPST-1120 arm randomized per protocol against 29 evaluable (30 total) patients in the control arm showed: Unconfirmed responses of 30% for the TPST-1120 triplet arm (12/40) vs. 17.2% for the control arm (5/29), demonstrating a 74.4% relative improvement in objective response rate (ORR); Enrollment began in fall of 2021 and the cutoff date for these data was February 8, 2023, which was greater than six weeks after the last patient enrolled and allows for all patients to have had at least one scan.

Tempest expects the full data set to be presented by Roche at a medical meeting at a later date. ORR was determined by RECIST v1.1, and confirmed responses included at least two scans. The webcast will be available for replay for 30 days.

The Phase 1b/2 global randomized HCC study is part of Roche's Morpheus program and evaluates TPST-1120 in combination with the standard-of- care regimen of atezolizUMab and bevacizUMab in patients with unresectable or prostate HCC not previously treated with systemic therapy. To date, the trial has enrolled 70 patients to the 1120 arm and contemporaneous control arm at ~25 sites worldwide including in the United States and Europe, who received either the TPST-1120 combination or the standard-of-care program of atezolizumib and bevacizumib with primary efficacy endpoint of objective response rate, and key secondary endpoints including PFS and OS.