Benzinga | Jun 7, 2021 12:21PM EDT

Delcath Systems' Hepzato Achieves 44% Best Overall Response Compared to Best Alternative Care in Eye Cancer

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

* Data were presented at the American Society of Clinical Oncology Annual Meeting.

* Data showed that 44% of evaluable patients in the Hepzato arm had a 30% or greater reduction in target tumor lesions at one or more time points versus 17% for patients enrolled in the Best Alternative Care (BAC) arm.

* Hepzato Kit, percutaneous hepatic perfusion (PHP) system showed preliminary overall response rate nearly three times better versus BAC arm in both treated (32.9% vs. 13.8%) and preliminary intent to treat - ITT (29.2% vs. 10.3%).

* The preliminary disease control rate was approximately doubled in favor of PHP vs. BAC in both treated (71% vs. 38%) and preliminary ITT (63% vs. 29%).

* Preliminary progression-free survival was nearly tripled in PHP vs. BAC (9.03 months vs. 3.06 months).

* Data also covered previously announced preliminary data showing an overall response rate of 29.2% with a 95% confidence interval lower bound of 20%. Given the magnitude by which the lower bound exceeds the 8.3% prespecified threshold for success.

* As 57.1% of the subjects in the BAC arm were able to crossover to the PHP arm, this crossover design of the study, the overall survival benefit was confounded.

* On the safety front, the most common treatment-related severe adverse events were thrombocytopenia (14.9%), neutropenia (10.9%), and leukopenia (4.2%).

* See the slide presentation here.

* Price Action: DCTH shares are up 3.21% at $11.05 during the market session on the last check Monday.