ALX Oncology Gets Fast Track Status For Its Evorpacept To Treat Head And Neck Cancer

(RTTNews) - ALX Oncology Holdings Inc. (ALXO) on Monday said it received Fast Track designation for evorpacept in combination with Merck's KEYTRUDA for the first-line treatment of adults with PD-L1 positive advanced head and neck squamous cell carcinoma.

The FDA's decision is informed by the phase 1 ASPEN-01 study that showed preliminary antitumor activity and a favorable safety profile in checkpoint inhibitor-naïve patients with second-line or greater advanced HNSCC treated with evorpacept and pembrolizumab, the company said.

The company had initiated Phase 2 ASPEN-03 study in May 2021 in partnership with Merck to evaluate the anti-tumor efficacy of evorpacept plus KEYTRUDA in patients with first-line metastatic or unresectable, recurrent PD-L1 positive HNSCC.