Benzinga | Dec 2, 2021 08:02AM EST

Delcath Systems, Inc. Announces Phase 3 FOCUS Trial Results For Hepzato In Liver-Dominant Metastatic Ocular Melanoma, Including Initial Survival Data Analysis

On final analysis of the primary overall response (ORR) endpoint, HEPZATO further exceeded the predefined threshold for success with a median duration of response of 14 months

While overall survival data continues to mature, a Hazard Ratio (HR) analysis of survival at 12-months yielded a statistically significant advantage for HEPZATO over a Best Alternative Care (BAC) arm [HR=0.37, p=0.01] in patients who received one or more treatments

HEPZATO had statistically significant improvements over BAC in predefined exploratory analyses on ORR, DCR and PFS

NDA resubmission for HEPZATO expected by mid-2022