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Friday, April 25, 2025

ALX Checkpoint Inhibitor for Head and Neck Cancers Did Not Meet Phase 2 Primary Endpoints



ALX Oncology (ALXO) announced that its Phase 2 ASPEN-03 and ASPEN-04 clinical trials for evorpacept in combination with Merck's KEYTRUDA® did not meet primary endpoints for treating head and neck squamous cell carcinoma (HNSCC). The trials evaluated improved objective response rates compared to historical controls.

Despite encouraging trends in ASPEN-03, the company will discontinue pursuing evorpacept with pembrolizumab in HNSCC. However, ALX Oncology will continue multiple clinical trials of evorpacept combined with anti-cancer antibodies, citing positive results in HER2-positive gastric and breast cancer trials.

The company remains focused on evorpacept's primary mechanism of action - blocking the CD47 'don't eat me' signal on cancer cells - and its ongoing evaluation in colorectal cancer, breast cancer, non-Hodgkin lymphoma, and multiple myeloma trials.

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