NEW YORK - Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology company, has announced findings from a retrospective study published in the Annals of Surgical Oncology by independent researchers at Moffitt Cancer Center in Tampa, Florida. The study evaluated the efficacy of Delcath's HEPZATO KIT™ in treating metastatic uveal melanoma with liver metastases and showed improved outcomes in disease control and progression-free survival compared to other treatments.
The research focused on 30 patients who received the HEPZATO KIT, which combines the chemotherapeutic drug melphalan with a Hepatic Delivery System (HDS), as either first-line or second-line therapy. Results indicated a median overall survival (OS) of 22.4 months for first-line therapy and 18.4 months for second-line therapy. Hepatic progression-free survival (hPFS) for first-line therapy patients was 17.6 months, significantly longer than the 8.8 months for immunotherapy and 9.2 months for other liver-directed therapies. In second-line therapy, the median hPFS was not reached, demonstrating better outcomes than the alternatives.
Overall progression-free survival (PFS) was also favorable, with a median of 15.4 months for first-line therapy and 22.2 months for second-line therapy, outperforming other treatment options.
Dr. Jonathan Zager, Chief Academic Officer and Director of Regional Therapies at Moffitt Cancer Center, commented on the study's implications, stating, "The findings from this study reaffirm the critical role of melphalan/HDS in managing liver-dominant metastatic uveal melanoma." He also expressed a commitment to further research combining melphalan/HDS with systemic therapies to improve patient outcomes.
Delcath's HEPZATO KIT is approved in the United States for adult patients with metastatic uveal melanoma with specific criteria. In Europe, the device component, CHEMOSAT, is regulated as a Class III medical device for treating a variety of liver cancers.
This report is based on a press release statement from Delcath Systems, Inc. and provides a factual account of the study's findings without endorsing the claims. The study's results are a significant development for patients with metastatic uveal melanoma, offering a potential new line of treatment for this challenging condition.
In other recent news, Delcath Systems has reported significant developments. The company announced a substantial increase in Q2 2024 revenue, totaling $7.8 million, driven by the success of its products HEPZATO and CHEMOSAT. Delcath also received New Technology Add-on Payment status for HEPZATO from CMS, expected to further enhance U.S. revenue.
An independent study published in the European Society for Medical Oncology journal of Gastrointestinal Oncology revealed promising results for Delcath's CHEMOSAT Hepatic Delivery System in treating primary or secondary liver tumors. The study demonstrated a high disease control rate, with most patients experiencing tumor response or stable disease.
Delcath's financial position remains robust, with $19.9 million in cash and investments supporting its focus on clinical trials and market expansion. The company plans to increase active treatment sites from seven to 20 by the end of 2024, and aims to be cash flow positive by Q1 2025. These are recent developments that investors should monitor closely.
InvestingPro Insights
Delcath Systems, Inc. (NASDAQ:DCTH) has captured attention with its innovative HEPZATO KIT™, and recent findings have sparked interest among investors and analysts alike. As the company progresses, here are some key insights from InvestingPro that could be relevant for investors considering Delcath's potential:
InvestingPro Tips reveal that analysts are optimistic about the company's sales growth in the current year. This optimism could be influenced by the promising results of the HEPZATO KIT™ in treating metastatic uveal melanoma, as highlighted in the recent study. Furthermore, the sentiment is bolstered by the fact that four analysts have revised their earnings estimates upwards for the upcoming period, signaling confidence in the company's financial prospects.
InvestingPro Data provides a snapshot of Delcath's financial health and market performance. The company's market capitalization stands at $255.36 million, reflecting its size and investor valuation within the market. Despite not being profitable over the last twelve months, Delcath has demonstrated a significant return over the past week, with a 15.74% price total return. This short-term performance, along with a 78.47% return over the last year, suggests a positive trend in investor sentiment.
It's important to note that Delcath operates with a moderate level of debt, which could be indicative of a balanced approach to financing its operations and research endeavors. The company's liquid assets also exceed its short-term obligations, providing a degree of financial flexibility that could be crucial as it continues to invest in its treatment options and seeks to expand its market reach.
For those interested in diving deeper into Delcath's financials and market performance, InvestingPro offers a wealth of additional tips—15 in total—to help investors make informed decisions. These insights, along with the latest metrics and analysis, can be accessed through the InvestingPro platform at https://www.investing.com/pro/DCTH.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.