On September 30, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported the publication of data from the first part of the Phase Ib/II SENSITIZE Study at the European Society for Medical Oncology Congress 2019 in Barcelona (Press release, 4SC, SEP 30, 2019, https://www.4sc.com/news/first-domatinostat-combination-data-from-phase-ib-ii-sensitize-study-presented-at-esmo/ [SID1234539936]).
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The SENSITIZE study (ClinicalTrials.gov identifier: NCT03278665) 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 inhibitor).
In the first part of the study, three patient cohorts were treated at three different dose levels of domatinostat in combination with pembrolizumab. At the time of data cut-off (July 15th, 2019, study still ongoing) a total of 23 patients were enrolled into the study:
Domatinostat in combination with pembrolizumab was safe and well tolerated
No increase in frequency or intensity of immune-related AEs observed
Signs of efficacy were observed, including one patient with a confirmed partial response and 7 patients with stable disease (4 confirmed)
Indication of dose-dependency for domatinostat, with best results at the highest dose
Preliminary biomarker analyses indicate a domatinostat-induced change in immunological tumor patterns
Jason Loveridge, Ph.D., CEO of 4SC: "Taking note of the favorable safety profile and first signs of clinical efficacy from the combination of domatinostat and pembrolizumab in this very hard to treat, anti-PD-1-refractory patient population is exciting and hugely encouraging. Especially since the preliminary tumor analyses indicates a confirmation of the proposed domatinostat-induced immunological effect. As such, we believe that the combination of domatinostat with anti-PD-(L)1 will provide a valuable therapeutic option for patients that do not respond to checkpoint blockade alone and we now look forward to starting our MERKLIN study in a comparable group of patients with Merkel-cell carcinoma within the coming months."