Tempest Gets Fast Track for Amezalpat

FDA has granted Tempest Therapeutics a fast track designation for amezalpat (TPST-1120), a small molecule, selective PPAR⍺ antagonist for treating patients with hepatocellular carcinoma (HCC). The company says the designation is based on positive data across multiple key study endpoints in a global randomized Phase 1b/2 study evaluating amezalpat plus standard-of-care atezolizumab and bevacizumab versus atezolizumab and bevacizumab alone in HCC patients. For example, there was a six-month improvement in median overall survival for patients receiving the amezalpat combination therapy, it says. “In addition, a survival benefit from the addition of amezalpat was preserved in key sub-populations including PD-L1 negative disease, which is consistent with amezalpat’s proposed mechanism of action to target both the tumor cells directly and the patient’s immune system.”