Detailed Narrative
Commercial Execution and Center Expansion
The company reported strong commercial execution for metastatic uveal melanoma, with HIPPSADO kit revenue up 21% year-over-year despite the introduction of 340B pricing. They activated two new treatment centers in Q2, bringing the total to 31, and are on track to reach 37 by year-end. The focus is on high-quality centers, with approximately 80% of active sites holding NCI comprehensive designation and 41% of all NCI comprehensive care centers now part of their network.
New Patient Starts and Seasonality Mitigation
New patient starts remained solid, averaging approximately 0.5 new patients per site per month, generating volume for the second half of the year. To mitigate prior year's seasonality, the company has worked with centers to train backup treatment teams, particularly at high-volume sites, which is expected to ease📎 capacity constraints previously caused by staff absences.
Clinical Evidence and Combination Therapy
Data from the Chopin trial, published in The Lancet of Oncology, continues to accelerate broader adoption of combination approaches. An abstract presented at ASCO described an ongoing Phase 2 study of Hepzato followed by Keventfust in HLA-A2 positive metastatic uveal melanoma patients, aiming to move Hepzato to a co-first-line setting.
Pipeline Expansion into Other Liver-Dominant Cancers
Delcath is confident in Hepzato's potential in other liver-dominant cancers. A retrospective analysis presented at ESMO Breast Cancer showed 9 of 15 heavily pretreated metastatic breast cancer patients with liver-dominant disease achieved a hepatic partial response with percutaneous hepatic perfusion.
Sponsored Clinical Trials Progress
In the sponsored Phase 2 trial for metastatic colorectal cancer, 13 centers are actively screening, with recruitment improving as sites were added and training streamlined. The first patient was recently dosed in the HER2 negative metastatic breast cancer trial at the European Institute of Oncology in Milan, with additional sites activating. The company estimates a similar addressable population for both indications (6,000-10,000 US patients annually for third-line colorectal cancer).
Strategic Indication Selection and Trial Challenges
The initial selection of colorectal and breast cancer for trials was driven by physician interest and the significant liver dominance in CRC, despite the third-line CRC setting not being the largest population. Enrollment has been slower than anticipated due to challenges in educating and coordinating clinical trial teams, particularly integrating IR teams with oncology teams for this novel procedure. The company is actively addressing these issues.