New data from the Phase 1 TRANSCEND study assessing Juno Therapeutics' (JUNO -10.9%) CAR-T candidate JCAR017 in patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) showed a significant treatment benefit. The results were presented at ASH in Atlanta.
At dose level 2 (DL2)(100M cells), the overall response rate (ORR) at month 3 was 74% (n=14/19), including 13 (68%) complete responders. In the group of patients who reached six months of follow-up, half (n=7/14) were in complete remission.
On the safety front, one patient (n=1/67) in the core group experienced severe cytokine release syndrome (CRS) and 15% (n=10/67) experienced severe neurotoxicity (NT). In the DL2 arm, there were no cases of CRS and two cases (n=2/29) of NT.
The company is developing JCAR017 with Celgene (CELG +2.2%). A U.S. marketing application is on tap in H2 2018 with possible approval as early as year-end 2018.
Investors appear to be reacting to the neurotoxicity data in the context of what happened to JCAR015. The company terminated development of the former lead candidate due to an unacceptable rate of cerebral edema.