On September 13, 2017 4SC AG (4SC, FSE Prime Standard: VSC) reported that the Company’s development partner Yakult Honsha together with the investigators presented promising results of a multi-center, open-label Phase I study of 4SC’s resminostat in combination with S-1 chemotherapy in 27 Japanese patients with pre-treated biliary tract or pancreatic cancer at the ESMO (Free ESMO Whitepaper) 2017 Congress. The study was conducted by Yakult Honsha in Japan (Press release, 4SC, SEP 13, 2017, View Source [SID1234520529]). S-1 is a chemotherapy combination drug which is approved for the treatment of several solid tumor types including biliary tract or pancreatic cancer in Asia.
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The primary objective of the study was to investigate the dose-limiting toxicities of resminostat monotherapy as well as the combination of resminostat and S-1 chemotherapy to determine the recommended regimen that should be used in a subsequent Phase II study. The secondary objectives included safety and efficacy parameters.
Chigusa Morizane, M.D., from the Department of Hepatobiliary and Pancreatic Oncology at the National Cancer Center Hospital in Tokyo, Japan, summarized the results: "As planned, from three different dose and schedule cohorts, we identified a well-tolerated regimen of resminostat/S-1 combination therapy. We observed tumor shrinkage or disease stabilization in all patients with biliary tract cancer receiving second-line study treatment according to the recommended regimen. Advanced biliary tract cancers are highly lethal, but in patients receiving the combination of resminostat and S-1 chemotherapy we saw a remarkable median overall survival of 10.2 months with no disease progression for 5.5 months (in median). Overall, 3 patients continued study treatment for over 180 days and the treatment of 1 patient is still ongoing."
Frank Hermann, M.D., Chief Development Officer of 4SC, commented: "We are very pleased with these promising data. Yakult Honsha confirmed further investigation of the efficacy of resminostat/S-1 combination treatment in Japanese second line biliary tract cancer patients in a subsequent Phase II study to commence in the near future. In parallel, 4SC is continuing to evaluate resminostat for maintenance treatment in patients with advanced-stage cutaneous T-cell lymphoma in our pivotal RESMAIN study in Europe."