Kymriah Approval DLBCL

Kymriah Approval DLBCL

As of May 1, 2018, the FDA has approved Novartis’ CD19-targeted CAR-T therapy tisagenlecleucel (Kymriah) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

This new indication approval was based on the previous phase II “JULIET” clinical trial, in which Novartis’ CD19-targeted CAR-T therapy (CTL019, or Kymriah) demonstrated an overall response rate (ORR) of 50% (95% CI, 38%-62%) [Reference 1] in adult patients with relapsed or refractory DLBCL, with a complete response rate (CR) of 32% and a partial response rate (PR) of 18%. The median duration of response was not reached at the time of reporting.

Stephen J. Schuster, MD

The lead investigator of the JULIET trial, the Robert and Margarita Louis-Dreyfus Professor of Chronic Lymphocytic Leukemia and Lymphoma Clinical Care and Research at the University of Pennsylvania’s Perelman School of Medicine, and the Director of the Lymphoma Program at the Abramson Cancer Center, said: “The goal of Kymriah therapy is to provide a potentially curative treatment option for patients with relapsed or refractory DLBCL, who have often experienced multiple rounds of chemotherapy, some of whom have had stem cell transplants that have failed. With tisagenlecleucel, we have been able to significantly increase their chances of achieving and maintaining durable responses, without the need for stem cell transplants, demonstrating the potential benefit of this therapy for this deadly blood cancer.”

Professor Schuster added, “This indication approval provides physicians with a meaningful treatment option that has a consistent safety profile and can achieve and maintain durable responses without stem cell transplantation.”

On August 30, 2017, tisagenlecleucel (Kymriah) became the first FDA-approved CAR-T cell therapy for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (B-ALL) that is refractory or in second or later relapse.

References

Schuster SJ, Bishop MR, Tam CS, et al. Primary analysis of Juliet: A global, pivotal, phase 2 trial of CTL019 in adult patients with relapsed or refractory diffuse large B-cell lymphoma. Presented at: ASH Annual Meeting and Exposition; Dec. 9-12, 2017; Atlanta. Abstract 577.

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