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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