Novartis AG reported positive data from an interim analysis from its phase 2 trial of CTL019 to treat adult patients with relapsed or refractory diffuse large B-cell lymphoma, a cancer of B cells, a type of white blood cell responsible for producing antibodies.
The trial had a three-month overall response rate of 45%, with 37% of patients achieving a complete response and 8% achieving a partial response.
Novartis said the study met its primary objective at interim analysis. Among patients with three months or more of follow-up or earlier discontinuation, best overall response rate was 59%, with 43% achieving complete response and 16% achieving partial response.
In the study, 57% of all treated patients experienced any grade cytokine release syndrome, and 26% experienced grade 3/4 cytokine release syndrome using the Penn Grading Scale. Cytokine release syndrome is a known complication of the investigational therapy that may occur when the engineered cells become activated in the patient's body.
Full primary analysis from the trial is expected to be available later in 2017 and will serve as the basis for U.S. and EU regulatory submissions.
The U.S. Food and Drug Administration granted breakthrough therapy designation to the drug based on data from the trial in April.