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Tanja Obradovic

May 12, 2025, 04:43

Tanja Obradovic: Final analysis of the randomized phase 2 part of the ASPEN-06 study of evorpacept

Tanja Obradovic, Oncology Medical Strategy Advisor at Mercurial AI, shared a post on LinkedIn:

“Final analysis of the randomized phase 2 part of the ASPEN-06 study of evorpacept (ALX148 by ALX Oncology), a CD47 myeloid checkpoint inhibitor, in patients with HER2-overexpressing gastric/gastroesophageal cancer (GC) have been published and offers good lesson in navigation of the pipeline.

Patients with 2nd or 3rd line HER2+ advanced or metastatic GC that has progressed on or after prior anti-HER2 therapy were randomized to evorpacept plus standard of care (trastuzumab, ramucirumab and paclitaxel) vs standard alone. No significant difference in ORR compared to historical ORR of SOC despite significance vs SOC arm in the trial. Outcomes on SOC arms do fluctuate and patient number was small for the Part 2 (N=127) but it is indicative of questionable evorpacept potential to add substantial benefit on top of SOC likely needing much large study. So, not surprisingly company commented yesterday that in discussions with FDA randomized Phase III was expected so it will not seek approval in gastric cancer.

Evorpacept pipeline is spanning seven ASPEN trials but two of them in head and neck squamous cell carcinoma (HNSCC) in combination with keytruda (ASPEN-03 and ASPEN-04 trials) failed to meet primary objectives of improved ORR as announced few weeks ago. So, two other indications remain where evorpacept’s concept of CD47 myeloid checkpoint inhibition is still investigated – metastatic colorectal cancer (mCRC, 2L, EGFR-naïve) and breast cancer (BC, enhertu-experienced HER2 positive).”

Title: Final analysis of the randomized phase 2 part of the ASPEN-06 study: A phase 2/3 study of evorpacept (ALX148), a CD47 myeloid checkpoint inhibitor, in patients with HER2-overexpressing gastric/gastroesophageal cancer (GC).

Journal of Clinical Oncology

Authors: Kohei Shitara, Zev A. Wainberg, Josep Tabernero, Eric Van Cutsem, Clélia Coutzac, Christelle De La Fouchardiere, Jeeyun Lee, Sun Young Rha, Yoon-Koo Kang, Philip Fanning, Grace An, Feng Jin, Alison J Forgie, Jaume Pons, Athanasios Tsiatis, Sophia Randolph, Keun-Wook Lee

Read the Full Article.

Tanja Obradovic

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