Delcath Systems Publishes FOCUS Study Subgroup Analysis Results
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 31 2025
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Should l Buy DCTH?
Delcath Systems announced the publication of results from subgroup analyses of the phase 3 FOCUS study. The publication was published in the Journal of Cancer Research and Clinical Oncology. The analysis assessed efficacy and safety in subgroups of patients treated with Delcath's Hepzato Kit, a drug/device combination for liver-directed treatment of mUM patients. The Hepzato Kit is currently the only liver-directed treatment to be approved by the FDA for patients with unresectable mUM. The article provides clinically relevant subgroup analyses of key efficacy endpoints, including overall response rate, progression-free survival and overall survival, and safety categories. Prespecified subgroups included age, sex, geographic region, extent of tumor liver involvement, hepatic tumor burden, presence of extrahepatic lesions, baseline LDH and number of prior therapies. This prespecified analysis of clinically relevant subgroups included 91 patients treated in the FOCUS study. Key efficacy and safety findings include: consistent tumor response was observed regardless of age, sex, geographic region, presence/absence of extrahepatic lesions, and prior therapy. Significantly higher ORR for patients with tumor burden below the median. No significant differences for other subgroups. Significantly longer median PFS for patients with tumor burden below the median. No significant differences for other subgroups. Significantly longer median OS for patients with smaller extent of tumor liver involvement, tumor burden below the median and low/normal LDH. Of the 33 patients achieving an objective response, 57.6% responded within the first or second treatment cycle, while one-third of responses were observed in Cycles 4-6. The overall safety profile was similar across subgroups, with no evidence of cumulative toxicity with successive treatment cycles. The incidence of serious adverse events and Grade 3/4 adverse events was consistent with the overall study population, and no treatment-related deaths occurred.
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Analyst Views on DCTH
Wall Street analysts forecast DCTH stock price to rise
5 Analyst Rating
5 Buy
0 Hold
0 Sell
Strong Buy
Current: 9.530
Low
18.00
Averages
24.50
High
30.00
Current: 9.530
Low
18.00
Averages
24.50
High
30.00
About DCTH
Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The Company's proprietary products, HEPZATO KIT (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure. HEPZATOTM KIT is a drug/device combination product. HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and the Company’s proprietary Hepatic Delivery System (HDS). In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan. In the United States, HEPZATO is regulated as a drug by the United States Food and Drug Administration (FDA).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Participation Details: Participants are advised to dial in 5 to 10 minutes before the call begins, with toll-free access at 1-877-407-3982 for U.S. callers and 1-201-493-6780 for international participants, ensuring timely access to the latest company updates.
- Webcast and Replay Availability: The call will be available via webcast at https://viavid.webcasts.com/starthere.jsp?ei=1747469&tp_key=15ec7bd15c, and a replay will be accessible shortly after the call concludes, allowing investors who cannot attend live to catch up on the discussion.
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- Patient Response Analysis: Among 91 participants, patients with lower tumor burden exhibited significantly higher response rates, and safety outcomes remained stable across various demographics, showcasing the therapy's broad applicability.
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See More
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- Survival Extension: Patients with tumor burden below the median exhibited a median progression-free survival (PFS) of 11.3 months, significantly longer than 5.8 months (p=0.007), providing essential evidence for clinical treatment strategies.
- Safety Consistency: Safety data across subgroups showed that the incidence of serious adverse events was consistent with the overall study population, with no treatment-related deaths, indicating the manageability and applicability of this therapy.
- Clinical Significance: Delcath's Chief Medical Officer emphasized that these analyses highlight the importance of early intervention in patients with lower tumor burden to maximize clinical benefits, further validating the HEPZATO KIT as a key treatment option.
See More
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See More
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- Earnings Call Announcement: Delcath Systems, Inc. has announced a conference call scheduled for February 26, 2026, at 8:30 AM Eastern Time to discuss its fourth quarter and full year results for 2025, aiming to provide investors with insights into its financial performance and future outlook.
- Participation Details: Participants are advised to dial in 5 to 10 minutes before the call begins, with toll-free access at 1-877-407-3982 for U.S. callers and 1-201-493-6780 for international participants, ensuring timely access to the latest company updates.
- Webcast and Replay Availability: The call will be available via webcast at https://viavid.webcasts.com/starthere.jsp?ei=1747469&tp_key=15ec7bd15c, and a replay will be accessible shortly after the call concludes, allowing investors who cannot attend live to catch up on the discussion.
- Company Overview: Delcath Systems focuses on interventional oncology for liver cancers, with its proprietary HEPZATO KIT and CHEMOSAT products designed to deliver high-dose chemotherapy while minimizing systemic exposure and side effects, highlighting significant clinical relevance in cancer treatment.
See More
Delcath Systems Reports Preliminary 2025 Revenue of $85.2 Million
- Revenue Growth: Delcath anticipates fourth quarter and full-year 2025 revenues of approximately $20.7 million and $85.2 million, indicating sustained growth potential in the liver cancer treatment sector.
- HEPZATO KIT Performance: Expected revenues for HEPZATO KIT are around $19.0 million and $78.8 million, reflecting strong market demand for the product and further solidifying Delcath's position in liver cancer treatment.
- Share Buyback Program: As of December 31, 2025, the company repurchased 628,572 common shares for $6.0 million, demonstrating confidence in its own value and creating shareholder returns.
- Clinical Trial Progress: HEPZATO procedure volume grew approximately 140% in 2025, showcasing the company's success in promoting new treatment options, which is expected to drive future revenue growth.
See More
Three Microcap Companies Show Healthy Growth: OPXS, DCTH, MAMA
- OPXS Business Growth: Optex Systems Holdings is experiencing rising revenue and expanding margins through the design and manufacture of advanced optical sighting systems, indicating stable demand and financial health in the defense market.
- DCTH Business Transformation: Delcath Systems is commercializing its FDA-approved liver cancer treatment, with revenue gradually increasing, marking a successful transition from development to execution and addressing a serious medical need.
- MAMA Expansion Momentum: Mama's Creations is growing revenue at a healthy pace through fresh food sales in supermarkets and club stores nationwide, while maintaining operational leverage and balance sheet discipline, showcasing sustainable growth potential.
- Common Traits: All three companies are improving financial quality alongside revenue growth, indicating their long-term investment value in the microcap market, quietly strengthening while the market is distracted.
See More
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- Clinical Value Reinforced: Delcath Systems' HEPZATO KIT demonstrated consistent tumor responses across nearly all patient categories in the Phase 3 FOCUS study, emphasizing its clinical value as the FDA-approved treatment for unresectable metastatic uveal melanoma.
- Patient Response Analysis: Among 91 participants, patients with lower tumor burden exhibited significantly higher response rates, and safety outcomes remained stable across various demographics, showcasing the therapy's broad applicability.
- Significant Revenue Growth: HEPZATO KIT generated $19.3 million in U.S. revenue during Q3 2025, a substantial increase from $10.0 million in the prior year, further solidifying its position as Delcath's primary commercial driver.
- Importance of Early Intervention: CMO Dr. Vojislav Vukovic highlighted the critical role of early intervention for patients with lower tumor burden, which not only validates the efficacy of HEPZATO KIT but may also drive future market demand.
See More
Delcath Publishes FOCUS Study Subgroup Analysis Results, Demonstrating Significant Efficacy
- Efficacy Analysis: The subgroup analysis from the FOCUS study reveals that patients with tumor burden below the median had an overall response rate (ORR) of 51.1%, significantly higher than 22.2% (p=0.008), indicating the critical importance of early intervention for optimizing treatment outcomes.
- Survival Extension: Patients with tumor burden below the median exhibited a median progression-free survival (PFS) of 11.3 months, significantly longer than 5.8 months (p=0.007), providing essential evidence for clinical treatment strategies.
- Safety Consistency: Safety data across subgroups showed that the incidence of serious adverse events was consistent with the overall study population, with no treatment-related deaths, indicating the manageability and applicability of this therapy.
- Clinical Significance: Delcath's Chief Medical Officer emphasized that these analyses highlight the importance of early intervention in patients with lower tumor burden to maximize clinical benefits, further validating the HEPZATO KIT as a key treatment option.
See More
Delcath Publishes 10-Year Study on Liver Cancer Treatment with 29.1 Months Survival Rate
- Survival Rate Improvement: Delcath's published study reveals that 38 patients with liver-dominant metastatic uveal melanoma, who underwent 99 CHEMOSAT® procedures, achieved a median overall survival of 29.1 months, significantly surpassing previous reports and underscoring the therapy's efficacy and safety.
- Impact of Treatment Cycles: The study indicates that patients receiving ≥3 PHP treatments had a median survival of 29.8 months compared to 21.4 months for those with ≤2 cycles, demonstrating the positive impact of repeated treatment cycles on survival and a ~40% reduction in death risk.
- No Treatment-Related Deaths: The study reported no treatment-related deaths and only 10.5% of patients experienced serious adverse events, highlighting the safety of CHEMOSAT® in real-world applications and enhancing confidence in its clinical use.
- Clinical Evidence Support: This research provides critical clinical evidence for treating liver-dominant metastatic uveal melanoma, emphasizing the importance of high-volume medical centers in optimizing treatment outcomes, which may drive the adoption of new management strategies.
See More
