Novartis has reported that the primary analysis of the Phase II ELARA trial of Kymriah (tisagenlecleucel) showed a complete response rate (CRR) of 66% in relapsed or refractory (r/r) follicular lymphoma (FL) patients.
A US Food and Drug Administration-approved therapy, Kymriah is the first CAR-T to receive approval in two separate indications, r/r acute lymphoblastic leukaemia and r/r diffuse large B-cell lymphoma.
This one-time therapy is developed to boost the immune system of the patients to fight cancer.
The single-arm, multi-centre, open-label Phase II ELARA trial assessed the efficacy and safety of Kymriah in adults with r/r FL. This global trial enrolled subjects from more than 30 centres in 12 countries globally.
CRR formed the primary goal of the trial, while overall response rate (ORR), duration of response (DOR), progression-free survival (PFS), overall survival (OS) and safety were included as secondary endpoints.
According to primary analysis data, Kymriah induced responses in most subjects who received the treatment, with an ORR of 86%.
The response rates were similar across high-risk subject subgroups in the trial.
However, median DOR in all responders, PFS and OS were not met, Novartis noted. The estimated DOR in subjects with CR and PFS rates were 94% and 76%, respectively at six months.
Furthermore, no grade 3/4 cytokine release syndrome, the most common side effect linked to CAR-T therapy, was observed in the trial subjects.
Novartis Oncology Cell & Gene global head Stefan Hendriks said: “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.”
The company plans to seek regulatory approvals globally for Kymriah in r/r FL treatment.
Last month, Novartis decided to terminate the two-year Phase III MERLIN clinical trial of Beovu (brolucizumab) in wet age-related macular degeneration patients despite meeting the primary endpoint.