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

Novartis 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). Kymriah is currently approved for use in at least one indication in more than 25 countries and at more than 250 certified treatment centers, with the ambition for further expansion to help fulfill the ultimate goal of bringing CAR-T cell therapy to every patient in need. As Novartis prepares for the launch of a potential third indication for Kymriah, manufacturing capacity continues to ramp up. The Novartis global CAR-T manufacturing footprint spans seven facilities total, across four continents. This comprehensive, integrated footprint strengthens the flexibility, resilience and sustainability of the manufacturing and supply chain. With recent approvals from the European Medicines Agency (EMA), commercial manufacturing of Kymriah is now ongoing at the Novartis-owned facilities in Stein, Switzerland and Les Ulis, France, joining the Novartis-owned facility in Morris Plains, New Jersey, USA. About the ELARA trial :ELARA is a Phase II, single-arm, multicenter, open-label trial investigating the efficacy and safety of Kymriah in adult patients with r/r FL. This international trial has enrolled patients from over 30 sites in 12 countries worldwide.