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CTL019 study, overall response rate at 3 months: 47% in diffuse large B-cell lymphoma and 73% in follicular lymphoma


Findings from an ongoing phase IIa study to evaluate the safety and efficacy of investigational chimeric antigen receptor T cell ( CART ) therapy CTL019 in certain types of relapsed or refractory ( r/r ) non-Hodgkin lymphoma were presented at the 57th American Society of Hematology ( ASH ) annual meeting.
The study, conducted by the University of Pennsylvania's Perelman School of Medicine (Penn), found an overall response rate ( ORR ) at three months of 47% (7/15) in adult patients with r/r diffuse large B-cell lymphoma ( DLBCL ) and an ORR of 73% ( 8/11 ) in adult patients with follicular lymphoma.

The findings include 26 adult patients ( 15 with DLBCL and 11 with follicular lymphoma ) who were evaluable for response. The study found that three patients with DLBCL who achieved a partial response ( PR ) to treatment at three months converted to complete response ( CR ) by six months.
In addition, three patients with follicular lymphoma who achieved a PR to treatment at three months converted to CR by six months. One DLBCL patient with a PR to treatment at three months experienced disease progression at six months after treatment. One follicular lymphoma patient with a PR to treatment at three months who remained in PR at nine months experienced disease progression at approximately 12 months after treatment. Median progression-free survival ( PFS ) was 11.9 months for patients with follicular lymphoma and 3.0 months for patients with DLBCL.

In the study, four patients developed cytokine release syndrome ( CRS ) of grade 3 or higher. CRS has been observed after CTL019 infusion when the engineered cells become activated and multiply in the patient's body. During CRS, patients typically experience varying degrees of flu-like symptoms with high fevers, nausea, muscle pain, and in some cases, low blood pressure and breathing difficulties. Neurologic toxicity occurred in two patients, including one grade three episode of delirium and one possibly related grade five encephalopathy.

In contrast to typical small molecule or biologic therapies, CTL019 is specifically manufactured for each individual patient.
A patient's T cells are collected through a specialized blood draw called leukapheresis and then transferred to the Novartis manufacturing facility in Morris Plains, New Jersey. There the cells are reprogrammed to hunt cancer and other B-cells expressing CD19. The patient's own modified cells are then transferred back to the treatment center where they are administered to the patient.

The Morris Plains facility is the first FDA-approved Good Manufacturing Practices quality site for a cell therapy production in the US and is now processing cells to support ongoing phase II multi-center global studies of CTL019 in specific leukemias and lymphomas. ( Xagena )

Source: Novartis, 2015

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