ALX Oncology has announced positive interim results with evorpacept in a study to treat advanced HER2-positive gastric cancer as part of its global randomised study.
Evorpacept is the first CD47 blocker to show activity in a global randomised study in solid tumours. The interim efficacy results showed that the confirmed overall response rate for evorpacept combination treatment was 52% compared to 22% for control treatment.
The Phase II/III ASPEN-06 (NCT05002127) randomised multi-centre international study was in combination with trastuzumab, ramucirumab and paclitaxel for the treatment of patients with HER2-positive gastric/gastroesophageal junction (“GEJ”) cancer.
The study found a confirmed overall response rate of 52% demonstrated for evorpacept in combination with trastuzumab as well as ramucirumab and paclitaxel compared to 22% for the control group of trastuzumab with ramucirumab and paclitaxel.
Approximately 450 adult patients are expected to be enrolled in the study in the study across both phases.
The trial, run in collaboration with Eli Lily, also found that the safety profile of evorpacept was consistent with previous clinical trials and was well-tolerated.
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Sophia Randolph, chief medical officer for ALX Oncology, said: “The ASPEN-06 clinical trial validates the potential of evorpacept both in solid tumours and in combination with anti-cancer antibodies and these data highlight the drug’s potential as a first-in-class foundational immunotherapy.”
GlobalData forecasts the drug to sell as much as $573m in 2029. Additionally, the drug has received Fast Track designation from the Food and Drug Administration in 2022, but only in specific indications of which the treatment of gastric cancer is one. It also has received orphan drug designation from the European Commission. GlobalData is the parent company of Clinical Trials Arena.
Keun Wook Lee, ASPEN-06 Principal Investigator, said: “Patients with the advanced disease face poor outcomes following progression on initial treatment with HER2-directed therapy. Evorpacept could represent a breakthrough in therapy and a potential paradigm shift in the gastric cancer care continuum.”