====Syndax Pharmaceuticals (SNDX) : updated results from ongoing Phase 2 ENCORE 601 trial

Syndax Pharmaceuticals announces updated results from ongoing Phase 2 ENCORE 601 trial of Entinosat in combination with KEYTRUDA in NSCLC; ORR results rate failed to meet prespecified endpoint 

• Updated results presented today include data from all 76 patients enrolled prior to the close of enrollment in December 2017 in the ongoing ENCORE 601 cohort enrolling non-small cell lung cancer (NSCLC) patients previously treated with both chemotherapy and PD-(L)1 therapy. It highlights the durability of the observed responses independent of prior treatment history or PD-(L)1 status.
• At the time of data cut-off, there were 7 confirmed partial responses (PRs) among the overall population of 72 efficacy-evaluable patients, for a 10% objective response rate (ORR), a median duration of response of 5.3 months, and a median progression free survival of 2.8 months.The results did not meet the prespecified ORR endpoint. Six of the 7 responders had low or negative PD-(L)1 expression at study entry. At the time of data cut-off, 6 patients remain on study.
• Updated data continue to demonstrate a manageable toxicity profile for the entinostat-pembrolizumab combination, with treatment emergent adverse events observed consistent with those previously reported.
• Exploratory analysis of baseline biomarkers in the fully enrolled cohort supports the previous observation from the first 57 patients that elevated pre-treatment baseline levels of peripheral classical blood monocytes are associated with enhanced clinical benefit to the entinostat-pembrolizumab combination.