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# ALX Oncology Seeking Accelerated OK for Evorpacept
- URL: https://www.fdaweb.com/alx-oncology-seeking-accelerated-ok-for-evorpacept/
- Published: 2025-01-24T12:00:00.000Z
- Updated: 2026-09-14T14:51:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158539

ALX Oncology says it plans to discuss with FDA its path for seeking accelerated approval for its investigational CD47-blocker evorpacept based on “positive updated data” from the ASPEN-06 Phase 2 clinical trial demonstrating the therapy generates a durable clinical response with a well-tolerated safety profile among patients with previously treated HER2-positive advanced gastric cancer or gastroesophageal junction (GEJ) cancer. “The updated data from the ASPEN-06 trial highlight the potential clinical utility of CD47 inhibition from evorpacept in combination with trastuzumab, ramucirumab and paclitaxel in patients with previously treated HER2-positive gastric cancer,” a company release says.

ASPEN-06 is a randomized international trial [(NCT05002127)](https://www.globenewswire.com/Tracker?data=TA6jSNaKQRtVdk7AR0rOXSegOiaJiDjwLpoEb814MSWNjHqF9rbJMGRKWR6hRqQNTV84GdgWEt2WYN-jNPQMe2Xp2CO1ow--Ko13%5FRa5N9Q1jhMPSwK6mfGp%5Fdxddbj6&ref=fdaweb.com) evaluating evorpacept in combination with trastuzumab, ramucirumab and paclitaxel (collectively, ETRP) against trastuzumab, ramucirumab and paclitaxel in patients with HER2-positive gastric/GEJ cancer. The updated data show ETRP demonstrated an “objective response rate of 41.3% compared to 30%” for the control population, the company says.

“The results from this trial tell a clear story that when a cancer cell is expressing HER2, evorpacept can combine with a regimen containing an anti-HER2 antibody such as trastuzumab to improve upon the activity you would expect from that regimen alone,” ALX Oncology says. “This is evidenced by the near doubling of PFS \[progression-free survival\] at one year among the patients with HER2-positivity….”