Phase 2 ELARA Trial Meets Primary End Point in R/R Follicular Lymphoma

Novartis announced that the interim analysis of the global phase 2 ELARA trial of tisagenlecleucel (Kymriah) found that the study met its primary end point of complete response rate (CRR), as assessed by independent review committee, in patients with relapsed or refractory follicular lymphoma.

Moreover, no new safety signals were observed with tisagenlecleucel. Novartis indicated that results from the trial will be presented at an upcoming medical meeting and included in US and EU regulatory submissions.

“We are pleased that [tisagenlecleucel] is showing meaningful results and may provide a potentially definitive treatment option for patients with relapsed and refractory follicular lymphoma,” John Tsai, MD, head of Global Drug Development and chief medical officer at Novartis, said in a press release. “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.”

The single-arm, multicenter, open-label, phase 2 ELARA trial is evaluating the safety and efficacy of tisagenlecleucel in adult patients with relapsed or refractory follicular lymphoma. The international trial has enrolled participants from over 30 sites across 12 countries.

Notably, the FDA granted regenerative medicine advanced therapy (RMAT) designation to tisagenlecleucel for this indication in the second quarter of 2020 based on preliminary results observed in the ELARA trial.

Tisagenlecleucel was the first chimeric antigen receptor (CAR) T-cell therapy to ever be approved by the FDA, and the first-ever CAR T-cell therapy to be approved in 2 distinct indications.

Currently, tisagenlecleucel is approved in the US for the treatment of pediatric and young adult (up to 25 years of age) patients with relapsed or refractory acute lymphoblastic leukemia (ALL), and adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The agent is also approved for use in at least 1 indication in more than 25 countries and at more than 250 certified treatment centers.

Reference:

Novartis announces Kymriah® meets primary endpoint at interim analysis of pivotal study in follicular lymphoma [news release]. Basel. Published August 4, 2020. novartis.com/news/media-releases/novartis-announces-kymriah-meets-primary-endpoint-interim-analysis-pivotal-study-follicular-lymphoma. Accessed August 4, 2020.