Kymriah: 68% of r/r follicular lymphoma patients experienced a complete response
Tisagenlecleucel, sold under the brand name Kymriah was the first gene therapy approved by the FDA on 30 August 2017. The first indication of Kymriah for Acute Lymphoblastic Leukemia was based on a multicenter clinical trial of 63 pediatric and young adult patients with relapsed or refractory B-cell precursor ALL. The overall remission rate within three months of treatment was 83 percent.
On 1 May 2018, the FDA gave Novartis and Kymriah the green light for the second indication to treat appropriate patients with Large B-Cell Lymphoma. In JULIET Pivotal Study, Kymriah showed an overall response rate (ORR) of 50% (95% confidence interval [CI], 38% – 62%), with 32% of patients achieving a complete response (CR) and 18% achieving a partial response (PR) in 68 patients evaluated for efficacy. In addition, the median duration of response was not reached among these patients, indicating sustainability of response according to the trial.
Finally, in May 2022, the indication scope of Kymriah was expanded to cover a new indication; relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy based on the ELARA trial. In this trial, 68% of patients receiving Kymriah experienced a complete response, with an 86% overall response rate. In addition, sustained clinical benefit from Kymriah treatment was demonstrated – of patients who achieved a complete response, 85% were still in response at 12 months.
