Benzinga | Mar 31, 2021 08:06AM EDT

Delcath Stock Moves Higher After Hepzato Achieves ORR Of 29.2% Beating Prespecified Threshold In Eye Cancer Study

* Delcath Systems Inc (NASDAQ: DCTH) has announced top-line preliminary results from the Phase 3 FOCUS trial of Hepzato Kit (melphalan hydrochloride for injection/hepatic delivery system) in patients with liver dominant metastatic ocular melanoma.

* Based on the preliminary analysis of 87% of enrolled patients, the assessed overall response rate (ORR) of 29.2% in the Intent to Treat population exceeded the predefined success criteria (21.0%) for the primary ORR endpoint.

* Evaluable patients in the HEPZATO arm showed ORR of 32.9% versus 13.8% for the Best Alternative Care (BAC) arm.

* The Median Progression-Free Survival for the BAC arm was 9.0 months versus 3.1 months.

* A Disease Control Rate of 70.9% was observed versus 37.9% for patients in the BAC arm.

* Duration of Response and Overall Survival is not yet evaluable.

* In the HEPZATO safety population of 94 patients, 38 patients (40.4%) experienced a treatment-emergent serious adverse event, most commonly were thrombocytopenia (14.9% of patients), neutropenia (10.6% of patients), and leukopenia (4.2% of patients), which were well-manageable.

* 5% of patients experienced treatment-emergent serious cardiac adverse events.

* The preliminary results are based on a data cut on March 12 and include 79 treated HEPZATO patients.

* Price Action: DCTH shares are trading 16.7% higher at $19 in premarket on the last check Wednesday.