Novartis has unveiled positive results from the Phase 2 ELARA trial, which evaluated Kymriah (tisagenlecleucel) to treat patients with relapsed or refractory (r/r) follicular lymphoma (FL).

The interim analysis demonstrated that the clinical trial met the primary endpoint of complete response rate (CRR), a standard measure of patient response to FL therapy, measured by the independent review committee. Kymriah produced no new safety signals in the study.

Kymriah is a one-time treatment designed to strengthen patients’ immune system to fight cancer and was developed under collaboration between Novartis and the Perelman School of Medicine at the University of Pennsylvania.

The Swiss pharmaceutical company is planning to use the clinical data from ELARA trial for regulatory submissions in the US and EU.

Novartis chief medical officer and global drug development head John Tsai said: “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.

“These results further support our efforts to re-imagine medicine in this incurable malignancy and reach this under-served patient population, who are historically burdened with several years of various treatments.”

Kymriah was granted FDA Regenerative Medicine Advanced Therapy (RMAT) designation

The company said that Kymriah is the first FDA approved CAR-T cell therapy, with two separate indications, and is currently approved for the treatment of patients with acute lymphoblastic leukaemia (ALL), and r/r adult diffuse large B-cell lymphoma (DLBCL), aged up to 25 years.

In addition, Kymriah has secured the FDA Regenerative Medicine Advanced Therapy (RMAT) designation, based on preliminary results from the ELARA trial.

Novartis claimed that the drug has been approved in more than 25 countries, and its global CAR-T manufacturing capability includes a total of seven facilities across four continents.

Following the recent European Medicines Agency (EMA) approvals, the company has begun the commercial manufacturing of Kymriah at its own facilities in Stein, Switzerland and Les Ulis, France, along with its facility in Morris Plains, New Jersey of the US.