Syndax suspends entinostat work after two trial flops

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Another PD-(L)1 combination has bitten the dust. This time, Syndax Pharmaceuticals’ HDAC inhibitor entinostat failed in trials with Roche’s Tecentriq and Pfizer/Merck KGaA’s Bavencio, in triple-negative breast cancer and ovarian cancer respectively. Syndax has postponed all work with entinostat plus checkpoint inhibitors, including a planned pivotal trial with Keytruda in non-small cell lung cancer. The company will await overall survival data from an NCI-sponsored trial of entinostat plus the aromatase inhibitor exemestane in breast cancer before making further decisions on the entinostat/PD-(L)1 combinations. This has effectively shifted Syndax's entire R&D focus to the phase I project SNDX-6352, which is being tested alone in graft-versus-host disease, and as monotherapy and in combination with Astrazeneca's Imfinzi in solid tumours; and the preclinical asset SNDX-5613, for which Syndax plans to submit an IND application in the second quarter of 2019. The group’s shares tumbled 11% post-market yesterday.

Entinostat’s clinical programme grinds to a halt
Study Combination Details Trial ID
Encore 601 Keytruda combo NSCLC and melanoma cohorts being presented at AACR; colorectal cancer cohort shelved NCT02437136
Encore 602 Tecentriq combo Previously treated, PD-1-naive triple-negative breast cancer – failed NCT02708680
Encore 603 Bavencio combo Heavily pretreated advanced epithelial ovarian cancer – failed NCT02915523
Encore 607 Keytruda combo NSCLC patients who have progressed on Keytruda + chemo – deferred n/a
E2112* exemestane combo HR+, Her2- breast cancer – interim analysis due in Q2 2019 NCT02115282
*Sponsored by the NCI. Sources: Syndax, clinicaltrials.gov.

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