- ALX Oncology's (ALXO, Financial) Phase 2 ASPEN-03 and ASPEN-04 trials for evorpacept with KEYTRUDA® did not meet primary endpoints.
- Despite setbacks in head and neck cancer trials, ALX Oncology will continue trials for evorpacept in other cancer types.
- Evorpacept has shown positive results in HER2-positive gastric and breast cancer trials with anti-cancer antibodies.
ALX Oncology Holdings Inc. (ALXO) announced that their Phase 2 ASPEN-03 and ASPEN-04 clinical trials evaluating evorpacept in combination with Merck's KEYTRUDA® for advanced head and neck squamous cell carcinoma (HNSCC) did not meet the primary endpoints. The trials aimed to achieve improved objective response rates (ORR) compared to historical controls, but the results were not sufficient to proceed to a registrational study.
Despite the failure of the trials to meet their primary objectives, ALX Oncology reported that the combination of evorpacept with pembrolizumab demonstrated a manageable safety profile. Consequently, the company will discontinue the development of evorpacept in combination with pembrolizumab for HNSCC.
However, ALX Oncology remains committed to exploring evorpacept in combination with anti-cancer antibodies, given its positive results in HER2-positive gastric and breast cancer trials. Evorpacept's mechanism of action involves blocking the CD47 'don't eat me' signal on cancer cells, enabling the immune system to target these cells more effectively.
The company will continue to pursue clinical trials of evorpacept with anti-cancer antibodies across multiple cancer types, including colorectal cancer, breast cancer, non-Hodgkin lymphoma, and multiple myeloma. These efforts are supported by previous clinical data that have demonstrated durable response rates and safety in various cancer indications when combined with therapies such as HERCEPTIN®, zanidatamab, and RITUXAN®.
