On December 27, 2018 4SC AG (4SC, FSE Prime Standard: VSC) reported, that the Safety Review Committee (SRC) consisting of clinical and drug safety experts evaluated the safety data from the second dose cohort and recommended continuation with the third dose cohort in the ongoing Phase Ib/II SENSITIZE study (ClinicalTrials.gov identifier: NCT03278665) (Press release, 4SC, DEC 27, 2018, View Source [SID1234532291]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The SENSITIZE study is enrolling up to 40 patients suffering from unresectable advanced-stage cutaneous melanoma who are refractory or non-responding to prior treatment with anti-PD-1 antibodies (checkpoint inhibitors). In the first part of the study, three patient cohorts will be treated at three different dose levels of domatinostat in combination with pembrolizumab. In the second part, additional patients will be treated with the recommended dosing regimen defined in the first dose-finding part of the study. 4SC anticipates top-line data to be available around the middle of 2019.

Susanne Danhauser-Riedl, M.D., Chief Medical Officer of 4SC, commented: "Safety and tolerability are key requirements for patients and physicians considering a drug. We are encouraged by the positive outcome of the first safety review earlier this year and the recent second one and are looking forward to enrolling patients into the third dose cohort. By continuing with the SENSITIZE study and the soon to be initiated investigator-sponsored EMERGE study of domatinostat in combination with the checkpoint inhibitor avelumab in patients with gastrointestinal cancer, we will continue to execute on our clinical development plan for domatinostat, which is intended to lead to the initiation of a potentially pivotal trial in H2 2019."