Novartis Says Tisagenlecleucel Met CRR in Early FL Data

Novartis this week announced that tisagenlecleucel (Kymriah), its chimeric antigen receptor (CAR) T-cell therapy, met its primary end point of complete response rate (CRR) in an interim analysis of a phase 2 study for relapsed or refractory (r/r) follicular lymphoma (FL).

The company said results from the global trial, Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma (ELARA), will be presented at an upcoming medical meeting. No new safety signals were seen.

Tisagenlecleucel is currently indicated for r/r pediatric and young adult acute lymphoblastic leukemia (ALL) as well as r/r adult diffuse large B-cell lymphoma (DLBCL).

Novartis plans to file for FDA approval for an FL indication in 2021.

“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,” John Tsai, MD, head of Global Drug Development and the company’s chief medical officer, said in a statement. “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.”

Last week, another drug was approved for DLBCL, with the FDA clearing tafasitamab, to be sold as Monjuvi by MorphoSys and Incyte. Tafasitamab is a humanized Fc-modified cytolytic CD19 monoclonal antibody being studied in several B-cell malignancies.

FL is a typically slow-growing or indolent form of non-Hodgkin lymphoma (NHL) that serves as the most common indolent lymphoma, accounting for approximately 20% of all NHL cases. While patients with FL can live for many years, the condition is generally not curable and is a chronic disease.

When in advanced stages, 12-month cumulative costs associated with FL were approximately 3.5 times higher for patients with progressive disease than for individuals without progressive disease ($30,890 vs $8704), indicating the importance of novel therapies to reduce disease burden.

Last month, the FDA approved the third CAR T-cell therapy, Kite Pharma’s brexucabtagene autoleucel. It is the first cell-based gene therapy to treat r/r mantle cell lymphoma.