ALX Oncology Reports Topline Data From ASPEN-06 Phase 2 Trial Demonstrating Evorpacept Improves Tumor Response in Patients With HER2-Positive Gastric Cancer

• Evorpacept is the first CD47 blocker to show durable clinical benefit and a well-tolerated safety profile in a prospective randomized trial

• Evorpacept combination achieved a confirmed overall response rate (ORR) of 40.3% compared to 26.6% for the control arm and demonstrated a median duration of response of 15.7 months compared to 7.6 months in the full trial population
• In the pre-specified population of patients with fresh HER2-positive biopsies, evorpacept combination showed the greatest benefit with ORR of 54.8% vs. 23.1% in the control, suggesting HER2-expression strongly correlates with evorpacept efficacy and validating its mechanism of action

Excerpt from the Press Release:

SOUTH SAN FRANCISCO, Calif., July 31, 2024 (GLOBE NEWSWIRE) — ALX Oncology Holdings Inc., (“ALX Oncology” or the “Company”) (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, today announced topline data from its Phase 2 ASPEN-06 clinical trial. The trial demonstrated clinically meaningful improvements in overall response rate and duration of response among patients with previously treated HER2-positive advanced gastric cancer (GC) or gastroesophageal junction (GEJ) cancer.

“The topline results from the ASPEN-06 clinical trial confirm the robust response that evorpacept can deliver, generating a clinically meaningful impact on key measures of anti-cancer activity for patients with gastric cancers and continuing to surpass benchmarks in the field,” said Jason Lettmann, chief executive officer at ALX Oncology. “Additionally, they provide valuable insight beyond the interim data previously reported, offering a more conclusive look at the impact of evorpacept and identifying the most responsive patient population. Importantly, the level of clinical benefit seen in this trial provides support for developing evorpacept in combination with anti-cancer antibodies in additional tumor types and drives ALX’s development strategy.”

ASPEN-06 is a randomized, multi-center, international trial evaluating evorpacept, ALX Oncology’s investigational CD47-blocking therapeutic that uniquely combines a high-affinity CD47-binding domain with an inactivated proprietary Fc domain, in combination with trastuzumab, CYRAMZA^® (ramucirumab) and paclitaxel (collectively, TRP) against TRP alone for the treatment of patients with HER2-positive gastric/GEJ cancer, where all patients had received an anti-HER2 agent in prior lines of therapy. Patients in the trial (N=127) were generally well-balanced across arms based on pre-specified stratification factors including line of therapy, prior ENHERTU^® (fam-trastuzumab deruxtecan-nxki) use, Asia region, tumor location (GC or GEJ), HER2 expression level (IHC3+ or IHC2+/ISH+) and HER2-positive biopsy (fresh or archival).

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