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Delcath Systems, Inc. Announces Positive 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
About this update from Delcath Systems, Inc.
[{"type":"text","content":"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 NEW YORK, Dec. 02, 2021 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today announced positive results from the phase 3 FOCUS study. The FOCUS study’s intent-to-treat (ITT) population was comprised of a total of 102 subjects, across various lines of therapy. Of the ITT group, 91 evaluable patients were administered at least one study treatment. Treatment with HEPZATO in the ITT analysis resulted in an objective-response-rate (ORR) of 31.4% [95% CI: 22.55-41.31], including 6.9% of patients with a complete response (CR). Median duration of response was 14 months [95% CI: 8.54, NC], with over half of responders continuing to be monitored for progression events. Disease control rate (DCR) was 65.7% [95% CI, 55.63, 74.81]. On the primary ORR endpoint, the lower bound 95% Confidence Interval (CI) of 22.55% exceeded the FOCUS trial’s prespecified 8.3% upper bound 95% CI threshold for success. This threshold was derived from a meta-analysis of sixteen checkpoint inhibitor publications documenting the treatment of 476 metastatic ocular melanoma patients. Supportive, predefined, exploratory analyses were conducted comparing patients in the HEPZATO arm versus a BAC group. The BAC arm was comprised of a total of 42 patients, originally randomized in the FOCUS trial prior to its amendment, in consultation with FDA, to a single-arm pivotal study in 2018. The evaluable BAC subjects were treated predominantly with liver-targeted Transarterial Chemoembolization (TACE). Among patients who received at least one study treatment, patients in the HEPZATO arm had statistically significant improvements over BAC in the following prespecifie...