Delcath Systems Announces Landmark CHOPIN Trial Results in The Lancet Oncology

Key Points and Investor Highlights

• Full results of the CHOPIN Phase 2 clinical trial published in The Lancet Oncology, validating the efficacy of combining Percutaneous Hepatic Perfusion (PHP) with immunotherapy (ipilimumab and nivolumab) for metastatic uveal melanoma (mUM).
• Synergistic combination shows substantial improvements in progression-free survival (PFS) and overall survival (OS).
• Potential for broader application in other liver-dominant cancers, signaling future expansion opportunities for Delcath Systems.
• Strong safety profile with manageable adverse events, reinforcing clinical confidence in the combination therapy.

Detailed Trial Results

Delcath Systems, Inc. (Nasdaq: DCTH), a leader in interventional oncology, announced that the detailed results from the investigator-initiated CHOPIN randomized Phase 2 clinical trial were published in The Lancet Oncology. The trial was led by Professor Ellen Kapiteijn, MD, from Leiden University Medical Center’s Department of Medical Oncology.

The CHOPIN trial was a single-center, open-label, randomized study of 76 patients with metastatic uveal melanoma. Patients were assigned to one of two arms:

• Percutaneous Hepatic Perfusion (PHP) with melphalan using Delcath’s CHEMOSAT® Hepatic Delivery System alone.
• Percutaneous Hepatic Perfusion combined with ipilimumab and nivolumab (immune checkpoint inhibitors).

Key findings from the intention-to-treat population include:

• Primary Endpoint: 1-year Progression-Free Survival (PFS)
  • PFS rate: 54.7% (combination) vs 15.8% (PHP alone)
  • Median PFS: 12.8 months (combination) vs 8.3 months (PHP alone)
  • Adjusted Hazard Ratio (HR): 0.34 (95% CI 0.19–0.60), p=0.0002
• Overall Survival (OS)
  • Median OS: 23.1 months (combination) vs 19.6 months (PHP alone)
  • HR: 0.39 (95% CI 0.20–0.77), p=0.0065
  • 2-year OS: 49.6% (combination) vs 22.1% (PHP alone)
• Objective Response Rate (ORR)
  • ORR: 76.3% (combination) vs 39.5% (PHP alone)
  • Complete Response (CR) rate: 13% (combination) vs 3% (PHP alone)
• Safety
  • Grade 3 or higher treatment-related adverse events: 82% (combination) vs 41% (PHP alone), p=0.0006
  • Most common events: thrombocytopenia (34% vs 14%), leukopenia (6% vs 14%), gamma-glutamyl transferase increase (18% vs 8%), anemia (13% vs 3%)
  • Most events were self-limiting or manageable; no new safety signals identified.
  • One treatment-related death (immune-related triple M syndrome) occurred in the combination arm.

Implications for Shareholders

• Clinical Validation: The Lancet Oncology publication provides independent validation of Delcath’s PHP platform, significantly enhancing its credibility and potential for adoption among oncologists and patients.
• Market Expansion Potential: The combination therapy may be explored in other liver-dominant cancers beyond metastatic uveal melanoma, representing a substantial new market opportunity.
• Regulatory Approvals: Delcath’s HEPZATO KIT is FDA-approved for unresectable hepatic metastases from mUM, with potential for increased adoption as clinical data supports broader use.
• Safety and Manageability: Despite higher grade 3/4 adverse events in the combination arm, manageable side effects and no new safety signals support the therapy’s risk-benefit profile.
• Forward-Looking Statements: The company expresses confidence in accelerating adoption and exploring additional indications, but cautions about risks related to commercialization, supply chain, regulatory inspections, and reimbursement.

About Delcath Systems and Products

Delcath Systems, Inc. focuses on interventional oncology for primary and metastatic liver cancers. Its proprietary products include:

• HEPZATO KIT: Combination drug-device product (melphalan for Injection/Hepatic Delivery System) approved by FDA for mUM with unresectable hepatic metastases affecting less than 50% of the liver and limited extrahepatic disease.
• CHEMOSAT Hepatic Delivery System: Device-only configuration approved in Europe for percutaneous hepatic perfusion procedures at major medical centers, treating a wide range of liver cancers.

The HEPZATO KIT allows for high-dose, liver-directed chemotherapy with controlled systemic exposure, reducing hepatotoxicity and improving tumor response rates.

Forward-Looking Statements and Risks

Delcath’s statements regarding future adoption, expansion into other cancer indications, and increased awareness are subject to risks such as commercialization success, supply chain management, regulatory approvals, and reimbursement challenges. Investors should monitor SEC filings for evolving risks and uncertainties. The company makes no guarantees about future performance and undertakes no obligation to update forward-looking statements.

Investor Relations Contact

For further inquiries, contact:
ICR Healthcare
[email protected]

Disclaimer: This article is for informational purposes only and does not constitute investment advice. Investors should review official SEC filings and consult with financial advisors before making any investment decisions. The information herein is based on public disclosures and subject to change without notice.

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