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The company released an interim analysis from its JULIET study with CTL019.
On June 7, 2017, Novartis released findings from an interim analysis of the Phase II JULIET study investigating its CAR-T cell therapy, CTL019 (tisagenlecleucel) in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The global study showed a three-month overall response rate of 45% (23 of the 51 patients evaluated), with 37% achieving a complete response and 8% achieving a partial response, respectively. Complete response remained stable from three months through data cutoff among the patient group.
The study met its primary objective at interim analysis. Among 51 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. The full JULIET primary analysis is expected to be available later this year and will serve as the basis for United States and European Union regulatory submissions, the company noted.
A total of 57% of all treated patients (85) experienced any grade cytokine release syndrome (CRS), and 26% experienced grade 3/4 CRS using the Penn Grading Scale. CRS is a known complication of the investigational therapy that may occur when the engineered cells become activated in the patient's body. There were no deaths attributed to CTL019, CRS, or cerebral edema, and no incidents of cerebral edema were reported in the study.
According to a statement from the company, JULIET is the first multi-center global registration study for CTL019 in adult patients with relapsed or refractory DLBCL and the second global CAR-T cell therapy trial, following the Novartis ELIANA study (NCT02435849) of CTL019 in pediatric and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). JULIET was conducted in collaboration with the University of Pennsylvania and enrolled patients from 27 sites in 10 countries across the United States, Canada, Europe, Australia, and Japan. It is the largest study examining a CAR-T cell therapy exclusively in DLBCL patients.