CD47-blocker and Keytruda combo fails in two Phase II trials: ALX Oncology

ALX Oncology has faced setbacks in 2025, including the downsizing of 30% of its workforce and the decision to drop certain pipeline assets. Despite these challenges, the company remains focused on its CD47-blocker, evorpacept, though the drug failed to show efficacy in two Phase II trials (ASPEN-03 and ASPEN-04) when combined with Keytruda (pembrolizumab) for treating advanced head and neck squamous cell carcinoma (HNSCC). The combination did not improve objective response rates (ORR) compared to Keytruda alone or with chemotherapy.

As a result, ALX has shifted its focus to exploring evorpacept in combination with other anti-cancer antibodies, such as Cyramza (ramucirumab), Herceptin (trastuzumab), Rituxan (rituximab), and Ziihera (zanidatamab). Despite the failure, the combination maintained a manageable safety profile. This trial failure follows prior disappointments with the drug, including gastric cancer trials and broader challenges with CD47 inhibition in cancer therapies.

03-05-2025