ALX Oncology’s evorpacept gets FDA ODD for gastric cancer and gastroesophageal junction cancer
ALX Oncology said that its CD47 blocker evorpacept has secured orphan drug designation (ODD) from the US Food and Drug Administration (FDA) in gastric cancer and gastroesophageal junction cancer (collectively GC).
According to the California-based clinical-stage immuno-oncology company, evorpacept is designed to combine a high-affinity CD47 binding domain with an inactivated Fc domain.
Gastric cancer is known to start in the cells lining the inner wall of the stomach. It spreads via the outer layers and ultimately throughout the body as it grows.
More than 26,000 newly diagnosed cases of gastric cancer and gastroesophageal junction cancer at all stages were estimated in the US in 2021.
Sophia Randolph — Chief Medical Officer of ALX Oncology said: “Receiving orphan drug designation from the FDA is an important regulatory milestone for ALX Oncology and reinforces the FDA’s recognition of evorpacept’s potential to improve clinical outcomes in patients with GC.
“In ASPEN-01, patients with >2L HER2 positive GC (n=18) treated with evorpacept in combination with trastuzumab plus ramucirumab and paclitaxel demonstrated an initial objective response rate of 72.2% with a median duration of response of 14.8 months and a median overall survival of 17.1 months [SITC 2021 poster]. These results compare favorably with the clinical experience with both ramucirumab plus paclitaxel and trastuzumab-deruxtecan in similar populations.”