Publication date: Jul 11, 2019
4SC AG: Positive safety review of Phase Ib/II SENSITIZE study of domatinostat + pembrolizumab in melanoma Safety Review Committee examined data from third dose cohort Combination treatment of domatinostat + pembrolizumab well tolerated and safe Data set to be presented at upcoming scientific conference A further two cohorts to be Germany, 11 July 2019 – 4SC AG (4SC, FSE Prime Standard: VSC) today announced, that the Safety Review Committee (SRC) consisting of clinical and drug safety experts evaluated the safety data from the third dose cohort in the Phase Ib/II SENSITIZE study (ClinicalTrials. gov identifier: NCT03278665).
The SENSITIZE study is a dose escalation study of domatinostat in combination with the checkpoint inhibitor pembrolizumab – an anti-PD-1 antibody approved in the US and the EU as a cancer immunotherapy – to evaluate the safety and tolerability of the combination treatment.
Frank Hermann, M. D., Chief Development Officer of 4SC, said: “The SENSITIZE study is a key study to evaluate the safety and tolerability of domatinostat in combination with checkpoint inhibitors such as pembrolizumab.
– Press release ends – Related articles 8 April 2019, Domatinostat’s mode of action in Merkel cell carcinoma 6 February 2019, First patient enrolled in Phase II study EMERGE of domatinostat (4SC-202) in gastrointestinal cancer 27 December 2018, Positive safety review of 4SC’s Phase Ib/II SENSITIZE study of domatinostat (4SC-202) + pembrolizumab in melanoma Further information About 4SC 4SC AG is a clinical-stage biopharmaceutical company developing small-molecule drugs that can target key indications in cancer with high unmet medical needs.
In this respect, 4SC initiated a Phase Ib/II study of domatinostat in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab in patients with advanced-stage melanoma.
A second Phase II study of domatinostat in combination with the anti-PD-L1 checkpoint inhibitor avelumab in patients with advanced-stage microsatellite-stable gastrointestinal cancer is conducted by Prof. David Cunningham of The Royal Marsden NHS Foundation Trust (London, UK).
As soon as results from the aforementioned trials will be available, 4SC plans to advance domatinostat into a potentially pivotal study in combination with a checkpoint inhibitor in PD-(L)1 refractory or relapsed patients with advanced Merkel-cell carcinoma (MCC).
|disease||DOID||Merkel cell carcinoma|
|disease||MESH||Merkel cell carcinoma|