Novartis: Kymriah Phase II Study Meets Primary Endpoint In Follicular Lymphoma
Swiss drug major Novartis AG (NVS) announced Tuesday positive results from the Phase II ELARA trial of Kymriah (tisagenlecleucel) in patients with relapsed or refractory follicular lymphoma or r/r FL.
At the interim analysis, the study met its primary endpoint of complete response rate, as assessed by independent review committee.
Follicular lymphoma is the second most common form of non-Hodgkin lymphoma. The ELARA trial is a Phase II, single-arm, multicenter, open-label trial investigating the efficacy and safety of Kymriah in adult patients with r/r FL.
Kymriah previously received FDA Regenerative Medicine Advanced Therapy or RMAT designation in r/r FL based on preliminary ELARA trial findings.
The latest results from the ELARA trial will be presented at an upcoming medical meeting. The trial findings will be included in regulatory submissions, with filing in the US anticipated in 2021, and the EU following.
Kymriah was the first-ever FDA-approved CAR-T cell therapy, and the first-ever CAR-T to be approved in two distinct indications. It is a one-time treatment designed to empower patients’ immune systems to fight their cancer.
The drug is currently approved for the treatment of r/r pediatric and young adult, up to 25 years of age, acute lymphoblastic leukemia or ALL, and r/r adult diffuse large B-cell lymphoma or DLBCL.
Kymriah was developed in collaboration with the Perelman School of Medicine at the University of Pennsylvania.
The drug is currently approved for use in at least one indication in more than 25 countries and at more than 250 certified treatment centers.
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