Novartis announces Kymriah meets primary endpoint at interim analysis of pivotal study in follicular lymphoma

• Global ELARA trial demonstrated clinically meaningful benefit in patients with relapsed or refractory (r/r) follicular lymphoma (FL) as measured by complete response rate
   
• Kymriah previously received FDA Regenerative Medicine Advanced Therapy (RMAT) designation in r/r FL based on preliminary ELARA trial findings, reflecting the unmet need for additional treatment options for this cancer type
   
• ELARA trial findings will be included in regulatory submissions, with filing in the US anticipated in 2021, and the EU following. Results will be presented at an upcoming medical meeting
   
• Interim analysis comes alongside milestones of 3,000^th batch of CAR-T cells manufactured for patients worldwide and approval for commercial manufacturing at two additional sites in Europe

Basel, August 4, 2020 — Novartis today announced positive results from the Phase II ELARA trial of Kymriah (tisagenlecleucel) in patients with relapsed or refractory (r/r) follicular lymphoma (FL). At the interim analysis, the global study met its primary endpoint of complete response rate (CRR), as assessed by independent review committee. CRR is a standard measure of patient response to therapy in FL. No new Kymriah safety signals were observed. Results from the ELARA trial will be presented at an upcoming medical meeting and included in US and EU regulatory submissions.

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. Kymriah is currently approved for the treatment of r/r pediatric and young adult (up to 25 years of age) acute lymphoblastic leukemia (ALL), and r/r adult diffuse large B-cell lymphoma (DLBCL)¹.

“We are pleased that Kymriah is showing meaningful results and may provide a potentially definitive treatment option for patients with relapsed and refractory follicular lymphoma,” said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer, Novartis. “These results further support our efforts to reimagine medicine in this incurable malignancy and reach this underserved patient population, who are historically burdened with several years of various treatments.”