ALX Oncology(US:ALXO) Globenewswire·2025-01-23 13:00Core Insights - ALX Oncology announced positive updated data from the ASPEN-06 Phase 2 clinical trial for evorpacept, a CD47-blocker, showing durable clinical responses and a well-tolerated safety profile in patients with previously treated HER2-positive advanced gastric cancer [1][2][8] Trial Overview - The ASPEN-06 trial is a randomized, multi-center, international study evaluating evorpacept in combination with trastuzumab, ramucirumab, and paclitaxel against a control group receiving trastuzumab, ramucirumab, and paclitaxel alone [2][3] - The trial's primary endpoints included overall response rate (ORR) and safety, with key secondary endpoints being duration of response (DOR), progression-free survival (PFS), and overall survival (OS) [3][6] Updated Results - The updated results presented at the 2025 ASCO GI Symposium highlighted an ORR of 48.9% and a median DOR of 15.7 months for the evorpacept combination, compared to 24.5% ORR and 9.1 months DOR in the control group [5][7] - In the intent-to-treat (ITT) population, the ORR for evorpacept plus control was 41.3%, significantly higher than the historical control of 30% [6][7] Safety Profile - Evorpacept was generally well tolerated, with adverse events consistent with those in the control group, indicating a favorable safety profile [7][8] Regulatory Status - The FDA has granted Fast Track designation to evorpacept for second-line treatment of HER2-positive gastric or GEJ carcinoma, along with Orphan Drug Designation from both the FDA and European Commission [9]