ALX Oncology Announces First Patient Dosed in ASPEN-06, a Phase 2/3 Study of Evorpacept for the Treatment of Patients with Advanced Gastric or Gastroesophageal Junction Cancer

Phase 2/3 study initiated in collaboration with Eli Lilly and Company

Excerpt from the Press Release:

SOUTH SAN FRANCISCO, Calif., March 02, 2022 (GLOBE NEWSWIRE) — ALX Oncology Holdings Inc., (“ALX Oncology” or the “Company”), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, today announced the first patient has been dosed in the Phase 2/3 ASPEN-06 study evaluating the combination of evorpacept, a next generation CD47 blocker, and CYRAMZA^® (ramucirumab), Eli Lilly and Company’s anti-VEGFR2 antibody, added to trastuzumab and paclitaxel for the treatment of patients with HER2-positive gastric cancer or gastroesophageal junction (“GEJ”) cancer.

ASPEN-06 (NCT05002127) is a randomized phase 2 (open-label) / phase 3 (double-blind), international, multi-center study to evaluate the efficacy of evorpacept in combination with ramucirumab, trastuzumab, and paclitaxel for the treatment of patients whose tumors have progressed following treatment with HER2-targeted therapy and chemotherapy. Approximately 450 adult patients will be enrolled in the study across both phases.

This study follows the ongoing ASPEN-01 Phase 1b trial in patients with HER2-positive gastric/GEJ cancer who have progressed following treatment with HER2-targeted therapy and chemotherapy (NCT03013218). As presented at the Society for Immunotherapy of Cancer’s 36^th Annual Meeting in 2021, evorpacept used in combination with ramucirumab, trastuzumab, and paclitaxel demonstrated an initial confirmed objective response rate of 72.2% with a median duration of response of 14.8 months, a 12-month overall survival rate of 79%, and a median overall survival of 17.1 months in patients who historically have low response rates and poor outcomes in this clinical setting [SITC 2021 poster].

“Patients with HER2-positive gastric/GEJ cancer are in need of tolerable and effective treatments, particularly in the 2nd line and later settings where resistance to HER2-directed therapy may have developed,” said Keun-Wook Lee, M.D., Ph.D., Professor of Seoul National University College of Medicine and Director of Clinical Trials Center, Seoul National University Bundang Hospital, Seoul, Korea. “Evorpacept’s favorable tolerability coupled with its novel approach of enhancing antibody dependent cellular phagocytosis engages the individual’s own innate anti-cancer immune response distinguishing it from other HER2-targeted approaches.”

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