01.08.2024 05:27:12

ALX Oncology: Phase 2 Data Shows Evorpacept Enhances Tumor Response In HER2-Positive Gastric Cancer

(RTTNews) - ALX Oncology Holdings Inc. (ALXO) announced topline data from its ASPEN-06 Phase 2 trial, revealing that Evorpacept significantly improves tumor response in patients with HER2-positive gastric cancer. The trial demonstrated clinically meaningful improvements in overall response rate and duration of response among patients with previously treated HER2-positive advanced gastric cancer (GC) or gastroesophageal junction (GEJ) cancer.

ALXO closed Wednesday's regular trading at $4.80 down $0.65 or 11.93%. In the after-hours trading, the stock further dropped $1.36 or 28.33%.

The company noted that Evorpacept combination achieved a confirmed overall response rate (ORR) of 40.3% compared to 26.6% for the control arm and demonstrated a median duration of response of 15.7 months compared to 7.6 months in the full trial population.

In the pre-specified population of patients with fresh HER2-positive biopsies, evorpacept combination showed the greatest benefit with ORR of 54.8% vs. 23.1% in the control, suggesting HER2-expression strongly correlates with evorpacept efficacy and validating its mechanism of action.

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to evorpacept for the second-line treatment of patients with HER2-positive gastric or GEJ carcinoma. Additionally, both the FDA and European Commission have granted Orphan Drug Designation for this indication.

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