Delcath Systems' CHOPIN Trial: A Catalyst for Market Re-Rating in Melanoma Treatment

The CHOPIN Trial: A Game-Changer for Uveal Melanoma Treatment

Delcath Systems' CHOPIN Phase 2 trial, evaluating the combination of percutaneous hepatic perfusion (PHP) with melphalan and immunotherapy (ipilimumab/nivolumab) for metastatic uveal melanoma (mUM), has emerged as a pivotal clinical catalyst. According to a report by Delcath, the Phase 1b portion of the trial demonstrated an 85.7% objective response rate (ORR) and 100% disease control rate in seven patients, with a median progression-free survival (PFS) of 29.1 months Delcath Systems Announces Updated Results from CHOPIN Phase 1b Trial^[4]. These results starkly contrast with historical outcomes for mUM, where immunotherapy alone typically yields ORRs of ~20% and PFS of 5–7 months Delcath Systems Announces Updated Results from CHOPIN Phase 1b Trial^[4].

The trial's innovative approach—delivering high-dose melphalan directly to the liver via PHP while pairing it with immunotherapy—addresses a critical unmet need. Uveal melanoma, a rare and aggressive cancer, has historically been resistant to immunotherapies due to its low mutational burden and immunosuppressive tumor microenvironment. By using PHP to "heat" the liver with chemotherapy and then leveraging immunotherapy to amplify systemic anti-tumor activity, Delcath's strategy aims to convert "cold tumors" into "hot tumors," enhancing immune recognition and response Delcath Systems Announces FDA Clearance of IND Application for Phase 2 Clinical Trial^[1].

ESMO 2025: The Inflection Point for Investor Sentiment

The upcoming presentation of CHOPIN Phase 2 data at the 2025 European Society for Medical Oncology (ESMO) Annual Congress on October 18 represents a key inflection point for Delcath's stock. As stated by Dr. Ellen Kapiteijn, the trial's principal investigator, the Phase 2 portion is designed to validate these early results in a larger cohort of 76 patients Delcath Systems Announces FDA Clearance of IND Application for Phase 2 Clinical Trial^[1]. If the Phase 2 data confirms the Phase 1b findings—particularly durable responses and manageable safety—investors are likely to re-rate Delcath's valuation.

Safety data from the Phase 1b trial also supports optimism. While grade III/IV adverse events (e.g., systemic inflammatory response syndrome, febrile neutropenia) were reported, no dose-limiting toxicities were observed Delcath to present phase 2 trial results at ESMO congress^[3]. This aligns with Delcath's broader goal of minimizing hepatotoxicity while maximizing therapeutic efficacy, a critical factor for regulatory and market acceptance.

Market Re-Rating Potential: From Niche to Mainstream

Delcath's current stock price (~$11.56) trades at a discount to its peers, despite a robust financial profile: 83–85% gross margins and a current ratio of 10.88x Delcath Systems Announces FDA Clearance of IND Application for Phase 2 Clinical Trial^[1]. Analysts have set price targets ranging from $21 to $31, reflecting confidence in the CHOPIN trial's potential to redefine mUM treatment paradigms. The ESMO presentation could catalyze a re-rating if the data demonstrates superiority over existing therapies like pembrolizumab or nivolumab monotherapy.

Moreover, Delcath's pipeline expansion into liver-dominant metastatic breast cancer (mBC) and colorectal cancer (mCRC)—supported by recent FDA clearance for Phase 2 trials—positions the company for broader market penetration. The HEPZATO KIT, already FDA-approved for mUM, could see label expansions if these trials replicate the CHOPIN success. For instance, the mBC trial, combining PHP with eribulin or capecitabine, aims to report hepatic PFS by 2028 Delcath Systems Announces FDA Clearance of IND Application for Phase 2 Clinical Trial^[1]. Such milestones could unlock new revenue streams, currently estimated at $94–98 million for 2025 Delcath Systems Announces FDA Clearance of IND Application for Phase 2 Clinical Trial^[1].

Competitive Landscape and FDA Pathway

Delcath's approach outperforms existing mUM therapies on multiple fronts. For example, the FOCUS Phase 3 trial of PHP alone reported a 36.3% ORR and 9.03-month PFS, outperforming a Best-Alternative-Care arm Delcath to present phase 2 trial results at ESMO congress^[3]. The CHOPIN combination therapy, with its 29.1-month PFS, suggests a paradigm shift. Competitors like Merck (Keytruda) or Bristol-Myers Squibb (Opdivo) lack liver-targeted delivery systems, giving Delcath a unique therapeutic edge.

Regulatory tailwinds further bolster the case for Delcath. The FDA's recent clearance of IND applications for mBC and mCRC trials underscores the agency's confidence in the platform's safety and efficacy Delcath Systems Announces FDA Clearance of IND Application for Phase 2 Clinical Trial^[1]. If CHOPIN data at ESMO reinforces these signals, the path to label expansions—and potentially accelerated approvals—becomes clearer.

Conclusion: A High-Conviction Play on ESMO

The CHOPIN trial's presentation at ESMO 2025 is not just a data event—it's a potential market re-rating catalyst. With Phase 1b results already outperforming historical benchmarks and a Phase 2 trial poised to validate these findings, Delcath is positioned to redefine uveal melanoma treatment. For investors, the October 18 date marks a critical juncture: positive data could drive the stock toward its analyst price targets, while broader pipeline progress in breast and colorectal cancers offers long-term upside. In a landscape where innovation in liver-directed therapies is scarce, Delcath's CHOPIN trial could be the inflection point that transforms a niche player into a sector leader.