Delcath Announces Positive Results from Phase 3 FOCUS Trial for Hepzato in Liver-Dominant Metastatic Ocular Melanoma, Plans to Resubmit NDA

Delcath Announces Positive Results from Phase 3 FOCUS Trial for Hepzato in Liver-Dominant Metastatic Ocular Melanoma, Plans to Resubmit NDA

Delcath Systems announced positive results from the phase 3 FOCUS study evaluating Hepzato (melphalan hydrochloride for injection/hepatic delivery system) for patients with hepatic dominant ocular melanoma. On final analysis of the primary overall response (ORR) endpoint, HEPZATO exceeded the predefined threshold for success with a median duration of response of 14 months. Hepzato also showed statistically significant improvements over Best Alternative Care (BAC) in predefined exploratory analyses on ORR, Disease Control Rate (DCR) and Progression Free Survival (PFS). Based on this data, Delcath intends to refile an NDA submission in mid-2022.

The FOCUS study was conducted at the request of the NDA as part of its Complete Response Letter regarding the original NDA submission filed in 2012. In the letter the FDA stated the company must conduct another controlled randomized trial to demonstrate that the clinical benefits of Melphalan/HDS outweigh its risks. 

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.

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