Novartis Announces Positive Clinical Results for CAR-T Therapy Kymriah in Relapsed/Refractory Follicular Lymphoma, Paving Way for Third Indication

Novartis announced today that its CAR-T cell therapy, Kymriah (tisagenlecleucel), achieved positive results in the Phase 2 ELARA clinical trial for patients with relapsed/refractory (R/R) follicular lymphoma (FL). Interim analysis demonstrated that this global study met its primary endpoint of complete response rate (CRR), as assessed by an independent review committee. The results from the ELARA trial will be presented at an upcoming medical conference and included in regulatory submissions in the United States and the European Union.

Follicular lymphoma is the second most common type of non-Hodgkin lymphoma (NHL), an indolent lymphoma that accounts for approximately 22% of NHL cases. Although treatments are available to improve overall survival, follicular lymphoma is considered an incurable malignancy, characterized by a disease course marked by continuous relapses and remissions. Over their lifetime, patients with relapsed follicular lymphoma may undergo more than five different lines of therapy, with some receiving up to twelve. Furthermore, due to this pattern of relapse and remission, patients who do not respond to treatment or experience rapid relapse may exhaust all available therapeutic options.

Kymriah is the first CAR-T cell therapy approved by the FDA to target the CD19 antigen, and also the first CAR-T therapy approved for two distinct indications. It is a one-time treatment designed to enhance the patient’s immune system to fight cancer. Kymriah is currently approved for the treatment of patients with relapsed or refractory (R/R) acute lymphoblastic leukemia (ALL), as well as adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).

References:

[1] Novartis announces Kymriah^® meets primary endpoint at interim analysis of pivotal study in follicular lymphoma. Retrieved August 4, 2020, from http://www.globenewswire.com/news-release/2020/08/04/2072118/0/en/Novartis-announces-Kymriah-meets-primary-endpoint-at-interim-analysis-of-pivotal-study-in-follicular-lymphoma.html

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