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Post-Hoc Analysis Of Delcath's Phase 3 Trial Presented At ASCO


Delcath Systems, Inc. (NASDAQ: DCTH) announced that an exploratory analysis of the Company's Phase 3 trial was presented at the American Society of Clinical Oncology (ASCO) held in Chicago, IL this week. The poster— Percutaneous Hepatic Perfusion (PHP) with Melphalan in Patients with Unresectable Liver Metastases from Melanoma: A Post-Hoc Analysis of PHP Randomized vs. Best Alternative Care (BAC)-to-PHP Crossover vs. BAC Only Patients—was presented by Dr. Richard Alexander, Associate Chairman for Clinical Research and Surgery at the University of Maryland Medical Center, on behalf of the Company's Phase 3 trial investigators.

The exploratory analysis compared patients assigned to BAC who crossed over to PHP after disease progression (BAC-to-PHP crossover) with those who did not (BAC-only) and with those randomized to PHP-melphalan (chemosaturation therapy). The analysis found that as measured by the trial's primary endpoint of hepatic progression free survival (hPFS), the BAC-cross over arm of the study was consistent with the hPFS achieved in patients randomized directly to the chemosaturation arm. Furthermore, the study showed that crossover from BAC to the chemosaturation arm led to a median overall survival benefit of 11 months compared to treatment with BAC alone. The safety profile of chemosaturation in patients that crossed-over from BAC and patients randomized directly to chemosaturation was similar. Dr. Alexander concluded that chemosaturation is a new treatment option for unresectable metastatic melanoma in the liver.

"Dr. Alexander's conclusion from this analysis echoes the remarks made by our experts during Friday's analyst meeting, that chemosaturation therapy has the potential to play an important role in disease control in the liver," said Eamonn P. Hobbs, President and CEO of Delcath Systems. "Interest in chemosaturation therapy has been high during ASCO, and we expect to see an increasing number of patients being treated in Europe as the year progresses," added Mr. Hobbs. "We are also very pleased that the first European commercial center for CHEMOSAT, the European Institute of Oncology, reported during our analyst meeting that the second treatment performed with our Generation 2 CHEMOSAT® system achieved a reduction in side-effects consistent with the first treatment. The members of our panel stated that, in their opinion, if this performance continues to be validated in clinical practice, it is an important new dimension in the development of this new therapy for cancers in the liver."

Posted-In: News FDA


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