Novartis’ closely-watched CTL019 has elicited a strong response in cancer patients taking the experimental CAR-T cell therapy in a mid-stage trial.
Findings from an interim analysis of the multicentre Phase II JULIET study show a three-month overall response rate of 45 percent in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) treated with the drug.
Of those responding to CTL019 (tisagenlecleucel), 37 percent achieved a complete response (CR) and 8 percent achieving a partial response (PR), the firm noted. Also, all patients in CR at three months remained in CR at data cutoff.
"The overall response rate seen in this early analysis is impressive for these heavily pre-treated patients with relapsed/refractory DLBCL, who have limited treatment options," said JULIET lead investigator, Stephen Schuster, MD, Professor of Haematology/Oncology in the Perelman School of Medicine at the University of Pennsylvania and the Abramson Cancer Center.
"The goal for these patients is achieving durable response. The most promising aspect of these data is that, at the time of this interim analysis, all patients with complete response at three months have remained in complete response."
Full results are expected to be available later in 2017, and will serve as basis for US and EU regulatory submissions, the firm noted.
A new approach
CAR-T offers a new treatment approach in that it is specifically manufactured for each individual patient. During the process, T cells are drawn from a patient's blood and reprogrammed in the laboratory to create T cells that are genetically coded to hunt the patient's cancer cells and other B-cells expressing a particular antigen.
Novartis is already seeking permission to market CTL019 for relapsed and refractory paediatric and young adult patients with B-cell acute lymphoblastic leukaemia (ALL), with its filing currently receiving a six-month priority review by the US Food and Administration.
The drug picked up rights to CTL019 under an agreement with the University of Pennsylvania in 2012, which also gives it worldwide rights to CARTs developed in all cancer indications.