Phase 2 Interim Analysis Shows Improved Response in Patients with Follicular Lymphoma

Patients with relapsed or refractory follicular lymphoma treated with Kymriah (tisagenlecleucel) – a CAR T-cell therapy – achieved a target complete response rate, according to an interim analysis of the phase 2 ELARA trial.

There were also no new safety concerns observed at interim analysis, according to the agent’s manufacturer, Novartis.

“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,” said Novartis’s Chief Medical Officer Dr. John Tsai in a press release.

With this, the trial met its primary endpoint of complete response rate.

The multicenter, single-arm, open-label phase 2 trial is designed to assess the safety and efficacy of Kymriah in adults with relapsed/refractory follicular lymphoma enrolled in more than 30 sites across 12 countries worldwide. The Food and Drug Administration granted a Regenerative Medicine Advanced Therapy designation to Kymriah earlier this year for relapsed/refractory follicular lymphoma based on preliminary results of the ELARA trial.This designation can help expedite the development and review of Kymriah as a regenerative therapy for these patients.

Currently, Kymriah is approved to treat adults who have relapsed or refractory diffuse large B-cell lymphoma and to treat pediatric and young adult acute lymphoblastic leukemia.

Novartis plans to present these results at an upcoming medical meeting.

“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,” Tsai concluded.