4SC Release: Overall Survival Benefit For Resminostat In First-Line Liver Cancer Study Subgroup
4SC AG: Overall survival benefit for resminostat in first-line liver cancer study subgroup
• Data from a randomized, multi-center, 170 patient Phase II study with resminostat as first-line treatment of advanced liver cancer presented at 2017 Gastrointestinal Cancers Symposium
• Substantial increase in overall survival shown in platelet-defined patient subgroup for combination treatment with resminostat and sorafenib
• Subgroup included approximately 50% of the study population
• Resminostat treatment resulted in this subgroup in approximately 40% reduced risk of death
• Prospective clinical development plan for resminostat under discussion with Yakult Honsha
Planegg-Martinsried, Germany, 24 January 2017 – 4SC AG (4SC, FSE Prime
Standard: VSC) today announced that the study investigators presented the detailed scientific study analysis (abstract #252) from the multi-center, randomized, 170 patient Phase II study conducted by 4SC’s cooperation partner Yakult Honsha Co., Ltd. (Yakult Honsha) in Japan and South Korea at the 2017 Gastrointestinal Cancers Symposium in San Francisco, USA. The study evaluated 4SC’s epigenetic cancer drug resminostat in combination with sorafenib compared to sorafenib monotherapy as first-line treatment in patients with advanced liver cancer (hepatocellular carcinoma, HCC).
“As reported earlier, subgroup analysis of the Phase II study revealed that addition of resminostat to the standard of care sorafenib resulted in a prolonged time until disease progression and a substantial benefit in median overall survival in patients with a normal to high platelet count at study entry. At median, patients in this subgroup treated with resminostat and sorafenib survived for 13.7 months compared to 5.1 months in patients treated with sorafenib alone,” explains Frank Hermann, M.D., Chief Development Officer of 4SC. “For these subgroup patients with higher baseline platelet levels, the risk of death during the study was reduced by approximately 40%, which represents a substantial benefit for patients with advanced HCC who have very few therapeutic alternatives.”
What are platelets and what’s their role in liver cancer?
Platelets, also called thrombocytes, are a component of our blood whose main function is to stop bleeding. “There is increasing evidence, provided by both basic and translational research, that platelets and platelet-derived factors may promote the development and diffusion of HCC. Moreover, clinical studies have shown that increased platelet counts may be associated with a more aggressive form of HCC and poorer prognosis,” explains Prof. Edoardo Giannini, Associate Professor at the Gastroenterology Unit in the Department of Internal Medicine of the University of Genoa, Italy, and participant at the global HCC advisory board meeting of 4SC and Yakult Honsha.
Further clinical development of resminostat in advanced liver cancer
“These are the first clinical data obtained in a randomized, controlled Phase II trial conducted in patients with advanced HCC indicating that platelet count might serve as a potentially relevant selection criterion. These interesting results are worthy of further exploration in a pivotal Phase III study,” continues Prof. Giannini.
Jason Loveridge, Ph.D., CEO of 4SC, concludes: “Although baseline platelet count is not yet an established selection criterion for patients in oncology and particularly in HCC, we have received a lot of positive feedback from leading experts in the HCC field. particularly since the patients where we see most benefit, are those with more advanced disease and with poorer prognosis. The increased overall survival benefit from the combination of resminostat and sorafenib is highly encouraging and certainly worth investigating in a further clinical study. To this end we are currently discussing our plans for the further development of resminostat with Yakult Honsha.”
• Data from a randomized, multi-center, 170 patient Phase II study with resminostat as first-line treatment of advanced liver cancer presented at 2017 Gastrointestinal Cancers Symposium
• Substantial increase in overall survival shown in platelet-defined patient subgroup for combination treatment with resminostat and sorafenib
• Subgroup included approximately 50% of the study population
• Resminostat treatment resulted in this subgroup in approximately 40% reduced risk of death
• Prospective clinical development plan for resminostat under discussion with Yakult Honsha
Planegg-Martinsried, Germany, 24 January 2017 – 4SC AG (4SC, FSE Prime
Standard: VSC) today announced that the study investigators presented the detailed scientific study analysis (abstract #252) from the multi-center, randomized, 170 patient Phase II study conducted by 4SC’s cooperation partner Yakult Honsha Co., Ltd. (Yakult Honsha) in Japan and South Korea at the 2017 Gastrointestinal Cancers Symposium in San Francisco, USA. The study evaluated 4SC’s epigenetic cancer drug resminostat in combination with sorafenib compared to sorafenib monotherapy as first-line treatment in patients with advanced liver cancer (hepatocellular carcinoma, HCC).
“As reported earlier, subgroup analysis of the Phase II study revealed that addition of resminostat to the standard of care sorafenib resulted in a prolonged time until disease progression and a substantial benefit in median overall survival in patients with a normal to high platelet count at study entry. At median, patients in this subgroup treated with resminostat and sorafenib survived for 13.7 months compared to 5.1 months in patients treated with sorafenib alone,” explains Frank Hermann, M.D., Chief Development Officer of 4SC. “For these subgroup patients with higher baseline platelet levels, the risk of death during the study was reduced by approximately 40%, which represents a substantial benefit for patients with advanced HCC who have very few therapeutic alternatives.”
What are platelets and what’s their role in liver cancer?
Platelets, also called thrombocytes, are a component of our blood whose main function is to stop bleeding. “There is increasing evidence, provided by both basic and translational research, that platelets and platelet-derived factors may promote the development and diffusion of HCC. Moreover, clinical studies have shown that increased platelet counts may be associated with a more aggressive form of HCC and poorer prognosis,” explains Prof. Edoardo Giannini, Associate Professor at the Gastroenterology Unit in the Department of Internal Medicine of the University of Genoa, Italy, and participant at the global HCC advisory board meeting of 4SC and Yakult Honsha.
Further clinical development of resminostat in advanced liver cancer
“These are the first clinical data obtained in a randomized, controlled Phase II trial conducted in patients with advanced HCC indicating that platelet count might serve as a potentially relevant selection criterion. These interesting results are worthy of further exploration in a pivotal Phase III study,” continues Prof. Giannini.
Jason Loveridge, Ph.D., CEO of 4SC, concludes: “Although baseline platelet count is not yet an established selection criterion for patients in oncology and particularly in HCC, we have received a lot of positive feedback from leading experts in the HCC field. particularly since the patients where we see most benefit, are those with more advanced disease and with poorer prognosis. The increased overall survival benefit from the combination of resminostat and sorafenib is highly encouraging and certainly worth investigating in a further clinical study. To this end we are currently discussing our plans for the further development of resminostat with Yakult Honsha.”