Juno Therapeutics, Celgene report additional data from TRANSCEND study
TRANSCEND is an open-label, multicenter Phase 1 study to determine the safety, pharmacokinetics, and antitumor activity of JCAR017 in adult patients with relapsed or refractory diffuse large B cell lymphoma, primary mediastinal B-cell lymphoma, follicular lymphoma Grade 3B, and mantle cell lymphoma.
As with previous readouts, the TRANSCEND data were presented for both the core and full groups.
The core group includes 29 patients who received dose level two, 34 patients who received dose level one, and 4 patients who received dose level one twice, approximately 14 days apart.
The core group includes patients with DLBCL who are ECOG Performance Status 0-1. These patients represent a high-risk patient population, with approximately 90% of treated patients having one or more predictors of poor survival, including double or triple hit lymphoma, being chemorefractory to front-line or subsequent therapies, never reaching a complete remission with prior treatments, or never having undergone an autologous transplant.
Enrollment of the pivotal cohort is ongoing with the core group at DL2. The full analysis group represents evaluable r/r patients in the DLBCL cohort, which includes an additional 24 patients with poor performance status or with niche subtypes of aggressive NHL.
In both analysis groups all efficacy data are based on at least one month of follow-up with a 28-day restaging scan and all safety evaluable data are based on having received JCAR017 with at least one month of follow-up. Product was available for 98% of patients apheresed in the DLBCL cohort.
Topline data from the presentation as of the October 9 data cutoff date included: Responses in core group: At DL2, the data showed a 3 month overall response rate of 74% and a 3 month complete response rate of 68%. Of patients that have reached 6 months of follow-up, 50% were in CR.
Across doses, 80% of patients with CR at 3 months stayed in CR at 6 months, and 92% of patients in response at 6 months remain in response as of data cutoff.
Across doses, median duration of response was 9.2 months and median durability of CR was not reached. Tolerability in core group:1% experienced severe cytokine release syndrome and 15% experienced severe neurotoxicity. 36% had any grade CRS and 21% had any grade NT. 58% had no CRS or NT of any grade.
At dose level 1, 3% experienced severe CRS and 21% experienced severe NT. At dose level 2, 0% experienced severe CRS and 7% experienced severe NT. 13% received tocilizumab and 18% received corticosteroids. Tolerability across doses in full group:1% experienced severe CRS and 12% experienced severe NT. 35% had any grade CRS and 19% had any grade NT. 60% had no CRS or NT of any grade.
The most common treatment-emergent adverse events other than CRS and NT that occurred at greater than or equal to 25% included neutropenia, anemia, fatigue, thrombocytopenia, nausea, and diarrhea. The most common TEAEs were similar between core and full groups.
CELG closed at $106.09. JUNO closed at $58.65
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