ALX Oncology's Evorpacept Gets Orphan Drug Tag For Gastric Cancer

The FDA has granted Orphan Drug Designation to ALX Oncology Holdings Inc's ALXO evorpacept for gastric cancer and gastroesophageal junction cancer.

  • In ASPEN-01, patients with >2L HER2 positive gastric (n=18) treated with evorpacept combined 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. 
  • Related content: Benzinga's Full FDA Calendar.
  • These results compare favorably with the clinical experience with both ramucirumab plus paclitaxel and trastuzumab-deruxtecan in similar populations. 
  • Also See: ALX Oncology's Evorpacept Data Fails To Impress At ASH Presentation.
  • The Company is enrolling ASPEN-06 Phase 2/3 study of evorpacept for advanced HER2 positive gastric cancer.
  • Price Action: ALXO shares closed at $14.36 on Thursday
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