Policy & Regulation
Novartis reveals results from two analyses of real-world experience with Kymriah
11 December 2019 -

Switzerland-based Novartis has revealed results from two analyses of real-world experience with Kymriah (tisagenlecleucel), the only CAR-T cell therapy approved in two distinct indications, it was reported yesterday.

Efficacy results for patients who received Kymriah in the real-world setting were similar to those showcased in JULIET. In this analysis of 80 patients with r/r diffuse large B cell lymphoma for whom three or more months of post-infusion outcomes were available, the overall response rate was 58% including 40% who achieved a complete response Median follow-up was 4.5 months. In the 24-month analysis of the JULIET trial, overall response rate was 52% and complete response was 38% (N=115) 3.

In this analysis of real-world experience with Kymriah (safety set, N=83), the rate of grade 3 or higher cytokine release syndrome and neurologic events were around 4% and 5%, respectively, as compared to 23% and 11% in the JULIET clinical trial (safety set, N=115), suggesting safety results appear more favourable. The real-world analysis used the grading scales ASTCT for CRS and ICANs for neurologic events, whereas the JULIET trial used the Penn Grading Scale for CRS and MedDRA SMQ for neurologic events.

The lead author of this real-world experience analysis, Samantha Jaglowski, MD, The Ohio State University Comprehensive Cancer Center – Arthur G James Cancer Hospital and Richard J Solove Research Institute (OSUCCC – James), said, 'With increased experience supplemented by real world data, physicians like myself have a better understanding of Kymriah and its safety profile. This along with the current practice of supportive care for CAR-T therapy provides the ability to routinely use this therapy in the hospital outpatient setting, which can reduce financial burden on patients and hospitals alike.'