Celgene announces initial clinical data of JCARH125 in multiple myeloma

Celgene announced initial safety data from its ongoing proof-of-concept trial of JCARH125 in patients with relapsed/refractory multiple myeloma. JCARH125 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 Annual Meeting. The data reported from the multicenter, phase 1/2 EVOLVE trial includes patients who have been treated with JCARH125 in the dose escalation study. The primary objectives of the phase 1 portion of the trial are safety and identification of a recommended phase 2 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. 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 , and 77% had high-risk cytogenetics. Seventy-one percent of patients experienced grade 1 and 2 cytokine release syndrome 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 in 86%, anemia in 50%, thrombocytopenia in 43% and infection in 14%. In this first report of JCARH125 data, the median follow up was only 11 weeks, yet among infused patients, the overall response rate was 82%. At the lowest dose level of 50×106 CAR T cells, the ORR was 79% and 43% of patients achieved stringent complete response or complete response.
https://thefly.com/landingPageNews.php?id=2831625