Syndax Pharmaceuticals (SNDX) announced the presentation of updated findings from the melanoma and non-small cell lung cancer, or NSCLC, cohorts of ENCORE 601, the company’s Phase 1b/2 trial evaluating the efficacy and safety of entinostat, its once-weekly, oral, small molecule, class I HDAC inhibitor, in combination with Keytruda, Merck’s (MRK) anti-PD-1 therapy. The data were presented during oral presentations at the American Association of Cancer Research Annual Meeting. The company presented results from the ENCORE 601 melanoma cohort that enrolled patients whose disease had progressed on or after anti-PD-1 therapy. Of 53 patients treated, a confirmed objective response was observed in 19% of patients per irRECIST criteria, with a clinical benefit rate of 36%. Median duration of response is 13 months. Four responders, all of whom have been on study therapy for over a year, currently remain on treatment. Efficacy results in patients who also received prior Yervoy therapy were consistent with the overall population. The entinostat-pembrolizumab combination was well tolerated with a manageable toxicity profile. Briggs Morrison, M.D., CEO of Syndax, said, “Both indications represent areas of high unmet need and we believe that available data warrant consideration to move the entinostat-pembrolizumab combination into one or more registration trials. As previously communicated, we look forward to determining next steps for the combination program following availability of overall survival results from E2112, our Phase 3 registration trial of entinostat plus exemestane in HR+, HER2- breast cancer, the next interim readout of which is expected in the second quarter of this year.”
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