Novartis releases positive JULIET trial results for Kymriah

Swiss pharma giant Novartis (NOVN: VX) on Saturday announced 14-month results from the pivotal JULIET clinical trial showing ongoing durable responses are achievable with Kymriah (tisagenlecleucel) when administered to adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL).

The new data on Kymriah, which was the first chimeric antigen receptor T cell (CAR-T) therapy for the treatment of patients with B-cell precursor acute lymphoblastic leukemia approved by the US Food and Drug Administration in August 2017, were presented at the 23rd Annual Congress of the European Hematology Association (EHA).

The overall response rate (ORR) was 52% (95% confidence interval [CI], 41% - 62%), among 93 evaluable patients who were followed for at least three months or discontinued earlier. A complete response (CR) was achieved in 40% of patients and 12% achieved a partial response (PR). Of the patients in CR at month 3, 83% remained in CR at month 12, and the median duration of response was not reached, indicating sustainability of response.