ALX Oncology Validates Evorpacept in Gastric Cancer Clinical Trial
News related to:ALX Oncology Holdings Inc · 3 min read
SOUTH SAN FRANCISCO, Calif., Sept. 28, 2026 /CourierPR/ -- ALX Oncology, a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, has announced the publication of clinical data from its ASPEN-06 randomized Phase 2 clinical trial in the prestigious scientific journal Nature Medicine. The data demonstrated that the company’s investigational CD47-blocker, evorpacept, generated encouraging efficacy with manageable safety among patients with previously treated HER2-positive advanced gastric cancer (GC) or gastroesophageal junction (GEJ) cancer.
The data showed that the combination of evorpacept with trastuzumab, ramucirumab, and paclitaxel achieved an objective response rate (ORR) of 40.3% compared to 26.6% for the control group in the intent-to-treat (ITT) population. Among patients with retained HER2-positive disease, based either on a fresh tumor biopsy or ERBB2 gene amplification detected in circulating tumor DNA (ctDNA), the ORR increased to 48.9% compared to 25.0% for the control arm.
Post-hoc biomarker analyses demonstrated that CD47 expression was a potential predictive biomarker for evorpacept. Among patients with retained HER2-positive disease and elevated CD47 expression (≥5% CD47 IHC3+ staining), the ORR increased to 63.6% compared to 23.1% for the control arm, with improvements in median progression-free survival (PFS) to 19.5 months versus 7.0 months and median duration of response (DOR) of 25.5 versus 8.4 months. These findings further support the hypothesis that both retained HER2 expression and elevated CD47 levels may be important drivers of efficacy through enhanced antibody-dependent cellular phagocytosis.
The ASPEN-06 clinical trial (NCT05002127) was a randomized Phase 2 (open-label)/3 (blinded) international, multi-center study evaluating evorpacept in combination with HERCEPTIN® (trastuzumab), CYRAMZA® (ramucirumab), and paclitaxel (TRP) compared to TRP alone for patients with metastatic second- or third-line HER2 overexpressing GC/GEJ adenocarcinoma who have progressed on or after prior HER2-directed therapy and fluoropyrimidine- or platinum-containing chemotherapy, and who were suitable for chemotherapy. One hundred twenty-seven adult patients were enrolled in the Phase 2 portion of the study.
Subgroup analyses revealed that patients whose tumors retained HER2 expression and had high CD47 expression experienced the greatest benefit from evorpacept-based therapy. These findings further support the proposed mechanism that both retained HER2 expression and elevated CD47 levels may be important drivers of efficacy through enhanced antibody-dependent cellular phagocytosis.
ALX Oncology, a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, has announced that the ASPEN-06 clinical trial data further validate the clinical potential of evorpacept and reinforce its biomarker-driven development strategy. The company’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications.
The ongoing Phase 2 ASPEN-09-Breast clinical trial (NCT07007559) evaluating evorpacept in combination with trastuzumab and chemotherapy in patients with HER2-positive metastatic breast cancer is expected to provide topline data from 80 patients in mid-2027. The company’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action. A Phase 1, dose-escalation trial of ALX2004 is ongoing in patients with EGFR-expressing solid tumors.
ALX Oncology, a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, has announced that the ASPEN-06 clinical trial data further validate the clinical potential of evorpacept and reinforce its biomarker-driven development strategy. The company’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications.
The ongoing Phase 2 ASPEN-09-Breast clinical trial (NCT07007559) evaluating evorpacept in combination with trastuzumab and chemotherapy in patients with HER2-positive metastatic breast cancer is expected to provide topline data from 80 patients in mid-2027.