Core Message - ALX Oncology announced positive updated data from the ASPEN-06 Phase 2 clinical trial for evorpacept, a CD47-blocker, showing durable clinical response and a well-tolerated safety profile in HER2-positive advanced gastric cancer (GC) or gastroesophageal junction (GEJ) cancer patients [1] - The updated results were presented at the 2025 ASCO Gastrointestinal Cancers Symposium, highlighting evorpacept as the first CD47 blocker to show substantial tumor response in a prospective randomized trial [5] Clinical Trial Results - The ASPEN-06 trial demonstrated an overall response rate (ORR) of 41.3% in the intent-to-treat (ITT) population for evorpacept plus TRP (ETRP), compared to 30% for RP historical control and 26.6% for TRP control [6] - In patients with fresh HER2-positive biopsies, ETRP showed an ORR of 59.1%, compared to 30% for RP historical control and 23.1% for TRP control [6] - Median duration of response (mDOR) was 15.7 months for ETRP in the ITT population, compared to 9.1 months for TRP control [6] - Median progression-free survival (mPFS) was 7.5 months for ETRP in the ITT population, compared to 7.4 months for TRP control [6] - In patients with confirmed HER2-positive expression, ETRP resulted in a 48.9% ORR, mDOR of 15.7 months, and mPFS of 7.5 months, compared to 24.5% ORR, mDOR of 9.1 months, and mPFS of 6.7 months in the TRP control group [7] Safety Profile - Evorpacept plus TRP was generally well tolerated, with adverse events consistent with those in the TRP control group [7] Regulatory Status - The FDA has granted Fast Track designation to evorpacept for the second-line treatment of HER2-positive gastric or GEJ carcinoma [9] - Both the FDA and European Commission have granted Orphan Drug Designation for this indication [9] Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing therapies that boost the immune system to treat cancer [11] - Evorpacept, the company's lead therapeutic candidate, is being evaluated in multiple ongoing clinical trials across various cancer indications [11] Presentation and Webcast - The updated ASPEN-06 data were presented at the 2025 ASCO Gastrointestinal Cancers Symposium [5] - ALX Oncology hosted a conference call and webcast on January 23, 2025, to review the updated data [10]
ALX Oncology Presents Positive Updated Data from ASPEN-06 Phase 2 Trial Demonstrating Evorpacept Generates Strong Response and Durable Clinical Benefit in Patients with HER2-Positive Gastric Cancer