Benzinga | Jul 28, 2021 07:09AM EDT

ALX Oncology Announces First Patient Dosed in ASPEN-04, a Phase 2 Study of ALX148 in Combination with KEYTRUDA and Chemotherapy for the Treatment of Patients with Advanced Head and Neck Squamous Cell Carcinoma

ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, in partnership with Merck, known as MSD outside the United States and Canada, today announced the first patient has been dosed in the Phase 2 ASPEN-04 study evaluating the combination of ALX148, a next generation CD47 blocker, with KEYTRUDA(r) (pembrolizumab), Merck's anti-PD-1 therapy, and standard chemotherapy for the treatment of patients with advanced head and neck squamous cell carcinoma ("HNSCC").



ASPEN-04 (NCT04675333) is an open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of ALX148 in combination with pembrolizumab and standard chemotherapy in patients with first line metastatic or unresectable, recurrent HNSCC who have not received prior systemic therapy for their advanced disease. This study will enroll patients regardless of PD-L1 expression status. The study is being conducted in collaboration with Merck and is based on promising clinical data reported from the ASPEN-01 Phase 1 study (NCT03013218), which provided the basis for ALX148's Fast Track Approval in HNSCC granted by the U.S. Food and Drug Administration.

"We are excited to expand the ALX148 clinical program with the initiation of a second Phase 2 trial, that has the potential to integrate ALX148 into current standard-of-care therapies for patients with PD-L1-unselected, treatment naive HNSCC," said Sophia Randolph, M.D., Ph.D., Chief Medical Officer, ALX Oncology. "The demonstrated tolerability of ALX148 with chemotherapy agents, when both myeloid and T cell checkpoints are inhibited, maximizes the potential anti-cancer immune response to novel tumor antigens. ASPEN-04 builds upon the promising combination activity we have already observed in patients with HNSCC, and provides an opportunity for more optimized anti-cancer activity."