Delcath Doses First Patient in Phase 2 Trial for Liver-Dominant Metastatic Breast Cancer — Delcath Systems, Inc.

Event summary

First patient dosed in Phase 2 trial (DELUMA) for HEPZATO™ in liver-dominant HER2-negative metastatic breast cancer.
Trial will enroll ~90 patients across >20 sites in the U.S. and Europe, comparing HEPZATO + SOC vs. SOC alone.
Primary endpoint is hepatic progression-free survival; secondary endpoints include overall response rate and survival metrics.
Approx. 7,000 annual U.S. patients with liver-dominant HER2-negative mBC are potential candidates for third-line treatment.

The big picture

Delcath is expanding its HEPZATO platform beyond metastatic uveal melanoma into a larger oncology market with significant unmet needs. The Phase 2 trial targets a population of ~7,000 U.S. patients annually, where liver metastases are often the primary cause of mortality. Success could validate Delcath’s approach of isolating high-dose chemotherapy to the liver, potentially opening new revenue streams in breast cancer treatment.

What we're watching

Trial Execution: Whether Delcath can maintain momentum in patient enrollment and site activation across global locations.
Regulatory Pathway: How Phase 2 data may position HEPZATO for potential expansion into metastatic breast cancer indications.
Commercial Strategy: The pace at which Delcath can educate physicians on liver-directed therapy for new patient populations.