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Novartis On Track to Pursue Kymriah Approval in Follicular Lymphoma After Promising Results

NEW YORK – Novartis on Wednesday indicated that based on promising response data from the Phase II ELARA trial, it will pursue regulatory approval for tisagenlecleucel (Kymriah) for relapsed or refractory follicular lymphoma.

In the pivotal Phase II ELARA trial, which Novartis will present during the American Society of Clinical Oncology's virtual annual meeting this week, 97 patients with relapsed or refractory follicular lymphoma received tisagenlecleucel, or tis-cel, and were evaluable for safety, 94 of whom were evaluable for efficacy. The median follow-up time for the trial was 11 months, during which 66 percent of patients achieved a complete response. The overall response rate was 86 percent, and while the median duration of response, progression-free survival, and overall survival times were not yet reached at the data cutoff point, 76 percent of patients were progression-free at six months

Notably, no patients experienced grade 3 or 4 cytokine release syndrome following tis-cel infusion, although about half of the patients experienced less severe, grade 1 or 2 cytokine release syndrome. The patients were all heavily pretreated with a median of four prior lines of therapy.

The autologous CAR T-cell therapy involves harvesting patients' immune cells, modifying them to target CD19 on the surface of cancer cells, then reinfusing them as a one-time treatment. Tis-cel is already approved in the US and over a dozen other countries for patients with relapsed or refractory diffuse large B-cell lymphoma, as well as for pediatric or young adult patients with relapsed or refractory acute lymphoblastic lymphoma.

"The strength of these pivotal results from the ELARA trial underscore the promising potential of Kymriah in the treatment of patients with relapsed or refractory follicular lymphoma," Stefan Hendriks, Novartis Oncology's global head of cell and gene therapies, said in a statement. "We look forward to advancing global regulatory submissions in this indication as quickly as possible."

According to Novartis, regulatory submissions are on track for the CAR T-cell therapy later this year. If approved, tis-cel would be another anti-CD19 CAR T-cell therapeutic option for refractory follicular lymphoma. The US Food and Drug Administration granted accelerated approval in March to axicabtagene ciloleucel (Gilead's Yescarta) for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.