Shares of Syndax Pharmaceuticals Inc. (NASDAQ: SNDX) saw a huge gain on Wednesday after the firm gave an update on its non-small cell lung cancer (NSCLC) midstage trial. Specifically, the company announced that Encore 601 has met the prespecified objective response threshold to advance into the second stage of the Phase 2 trial and will reopen enrollment immediately.
Encore 601 is a Phase 1b/2 clinical trial evaluating the combination of entinostat plus Merck’s anti-PD-1 blocking therapy, Keytruda (pembrolizumab). The trial is enrolling two distinct cohorts of NSCLC patients: those who had previously progressed on PD-1 or PD-L1 therapy and those naïve to PD-1 or PD-L1 therapy.
Also for the trial to be able to advance into the definitive stage of the Phase 2 study, at least two out of 20 NSCLC patients who had previously progressed on PD-1 or PD-L1 therapy or three out of 13 NSCLC patients previously “naïve” to PD-1 or PD-L1 therapy need to demonstrate an objective response — either a partial response (PR) or complete response (CR).
The cohort of NSCLC patients who had previously progressed on PD-1 or PD-L1 will now reopen and enroll a total of 56 patients. The company expects to complete enrollment in the first half of 2018. Later this quarter, Syndax anticipates being able to determine whether to expand the cohort of NSCLC patients naïve to PD-1 or PD-L1 therapy.
Matthew D. Hellmann, M.D., medical oncologist and immunotherapy expert at Memorial Sloan Kettering Cancer Center, commented:
PD-1 therapies have offered important clinical benefit to patients with NSCLC, but unfortunately only a subset of patients respond. There is tremendous need for new combinations to further improve responses to PD-1 therapies. The early data here with several objective responses to the entinostat – pembrolizumab combination in patients with NSCLC who previously progressed on PD-1 therapy is promising and certainly worth additional investigation.
Shares of Syndax were trading up 37% at $12.90 on Wednesday, with a consensus analyst price target of $26.13 and a 52-week trading range of $6.31 to $18.03.