Trial of Kymriah for advanced follicular lymphoma meets primary efficacy endpoint
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Tisagenlecleucel conferred clinically meaningful benefit to patients with relapsed or refractory follicular lymphoma, according to topline results of the phase 2 ELARA trial released by the agent’s manufacturer.
An interim analysis showed the trial of tisagenlecleucel (Kymriah, Novartis) — an autologous anti-CD19 chimeric antigen receptor T-cell therapy — met its primary endpoint of complete response rate as assessed by independent review committee. The manufacturer reported no new safety signals.
“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,” John Tsai, MD, head of global drug development and chief medical officer for Novartis, said in a company-issued 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.”
Tisagenlecleucel was developed through a first-of-its kind academia-industry collaboration between Novartis and University of Pennsylvania.
As Healio previously reported, the FDA granted regenerative medicine advanced therapy designation to tisagenlecleucel for patients with relapsed or refractory follicular lymphoma. This designation is reserved for novel therapies that show preliminary clinical evidence of their potential to address unmet medical needs.
Tisagenlecleucel has been approved by the FDA for children and young adults with relapsed or refractory acute lymphoblastic leukemia and adults with relapsed or refractory diffuse large B-cell lymphoma.
Complete data from the ELARA trial will be presented at an upcoming medical meeting and will be included in investigational new drug submissions for both U.S. and EU regulators, according to the release.
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