Novartis has revealed positive results from a phase 2 study of its CAR-T therapy Kymriah (tisagenlecleucel) in patients with relapsed or refractory follicular lymphoma.
Following an interim analysis of the phase 2 ELARA trial, researchers found that Kymriah met the primary endpoint of complete response rate (CRR) – a standard measure of response to therapy in FL patients.
Kymriah was the first CAR-T therapy to be approved by the US Food and Drug Administration (FDA) in August 2017, and is currently approved for two indications – relapsed or refractory paediatric and young adult acute lymphoblastic leukaemia and relapsed or refractory adult diffuse large B-cell lymphoma.
The therapy is a one-time treatment created individually for each patient using their own T cells. Kymriah was developed by Novartis in partnership with the University of Pennsylvania after the two parties signed a global collaboration deal for the therapy in 2012.
“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 of 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,” he added.
Following the positive results, and ahead of regulatory approval, Novartis has ramped up its global CAR-T manufacturing capacity at seven facilities across four continents.
According to Novartis, findings from the ELARA trial will be included in regulatory submission, which are expected to be filed in the US in 2021 and in Europe soon after.