- A Phase 1 clinical trial, TRANSCEND, assessing Juno Therapeutics' (NASDAQ:JUNO -0.9%) JCAR017 in patients with relapsed/refractory diffuse large B cell lymphoma (DLBCL) showed a significant treatment benefit. The data were presented at the 58th American Society of Hematology (ASH) annual meeting in San Diego.
- In 20 efficacy-evaluable patients (including one with follicular lymphoma grade 3B) who received a single dose of 5x10(7) cells (dose level 1), the overall response rate was 80% (n=16/20), including 12 (60%) complete responders.
- In 22 safety-evaluable patients treated at dose level 1, no severe (grade 3) cytokine release syndrome (CRS) was observed, but 14% (n=3/22) experienced grade 3-4 neurotoxicity. The most frequent treatment-emergent adverse events were neutropenia (100%), decreased appetite (36%) and fatigue (32%).
- 100% (n=2/2) of patients receiving dose level 2 (1x10(8) cells) were complete responders. None of the three patients evaluated for safety experienced severe CRS or grade 3-4 neurotoxicity.
- The company intends to launch a pivotal study in r/r DLBCL in 2017. JCAR017 is also being investigated in pediatric r/r acute lymphoblastic leukemia.