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ALX Oncology Announces First Patient Dosed in ASPEN-03, a Phase 2 Study of ALX148 in Combination with KEYTRUDA® (pembrolizumab) for the Treatment of Patients with Advanced Head and Neck Squamous Cell Carcinoma
- The first of two distinct randomized Phase 2 studies in collaboration with Merck has been initiated BURLINGAME, Calif., May 10, 2021 (GLOBE NEWSWIRE) -- ALX
About this update from Alx Oncology Holdings Inc.
[{"type":"text","content":"- The first of two distinct randomized Phase 2 studies in collaboration with Merck has been initiated BURLINGAME, Calif., May 10, 2021 (GLOBE NEWSWIRE) -- 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-03 study evaluating the combination of ALX148, a next generation CD47 blocker, with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, for the treatment of patients with advanced head and neck squamous cell carcinoma (“HNSCC”). ASPEN-03 (NCT04675294) is an open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of ALX148 plus pembrolizumab in patients with first line metastatic or unresectable, recurrent PD-L1 positive HNSCC. This study is being conducted in collaboration with Merck and is based upon promising clinical data reported from the ASPEN-01 Phase 1 study (NCT03013218), which provided the basis for ALX148’s Fast Track designation in HNSCC granted by the U.S. Food and Drug Administration. “We are excited to have achieved this latest milestone of initiating the first Phase 2 trial in the ALX148 clinical program. We believe the combination of ALX148 and pembrolizumab exemplifies the broad therapeutic potential of inhibiting both myeloid and T cell checkpoints across a wide range of solid tumor cancers including HNSCC,” said Sophia Randolph, M.D., Ph.D., Chief Medical Officer, ALX Oncology. “ASPEN-03 builds upon the promising combination activity already observed in patients with HNSCC, and our team intends to continue to accelerate ALX148 development in both this and additional solid and hematological indications this year.” About Head and Neck Cancers Cancers that are known collectively as head and neck cancers usually begin in squamous cells. These cells line the moist, mucosal surfaces in head and neck structures such as the mouth, nose, and throat. These squamous cell cancers are often referred to as squamous cell carcinomas of the head and neck. It is estimated that there are over 50,000 newly diagnosed cases of HNSCC at all stages in the U.S. each year. The 5-year survival is only 40% for those patients diagnosed with metastatic disease...