Initial data from proof of concept trial of JCARH 125 to treat r/r multiple myeloma.- Celgene + Juno

Celgene Corporation announced initial safety data from its ongoing proof-of-concept trial of JCARH 125 in patients with relapsed/refractory multiple myeloma . JCARH 125 is an investigational BCMA-targeting CAR T cell therapy being developed by Juno Therapeutics, A Celgene Company. Results were presented by Sham Mailankody, MBBS, in an oral presentation at the 60th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, CA (Abstract #957).

The data reported from the multicenter, phase 1/2 EVOLVE trial includes patients who have been treated with JCARH 125 in the dose escalation study. The primary objectives of the phase 1 portion of the trial are safety and identification of a recommended phase II dose. The patients enrolled in the study had to have received at least three prior lines of multiple myeloma therapy, including an autologous stem cell transplant for transplant eligible patients, a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Dose escalation is currently ongoing.

�We believe that cellular therapies targeting BCMA will play an important role in the future treatment of patients with multiple myeloma,� said Mark Gilbert, M.D., Chief Medical Officer for Juno Therapeutics, A Celgene Company. �These data from 44 patients in the EVOLVE trial further support our commitment to innovation in multiple myeloma clinical research.�

At data cut off, 44 patients have been infused with JCARH125 in three dose escalation cohorts. These patients were heavily pretreated, with a median of seven prior lines of therapies (range, 3-23), and 77% had high-risk cytogenetics. Seventy-one percent of patients experienced grade 1 and 2 cytokine release syndrome (CRS) with 9% of patients experiencing grade 3/4 CRS. In addition, 18% of patients experienced grade 1 and 2 neurological events with 7% of patients experiencing a grade 3/4 event. Other frequent grade 3/4 AEs included neutropenia (86%), anemia (50%), thrombocytopenia (43%) and infection (14%). In this first report of JCARH 125 data, the median follow up was only 11 weeks, yet among infused patients, the overall response rate (ORR) was 82%. At the lowest dose level of 50x106 CAR T cells, the ORR was 79% and 43% of patients achieved stringent complete response (sCR) or complete response (CR). JCARH 125 is investigational and has not been approved in any country.