Novartis has reported positive data from the Phase II ELARA clinical trial of Kymriah (tisagenlecleucel) in patients with relapsed or refractory (r/r) follicular lymphoma (FL).
At the interim analysis, the trial met its primary endpoint of complete response rate (CRR). The drug is said to have shown clinically meaningful benefit on the CRR measure.
Results did not report any new safety signals with the drug.
Kymriah was developed in collaboration with the Perelman School of Medicine at the University of Pennsylvania. It is the first CAR-T cell therapy to receive US Food and Drug Administration (FDA) approval.
The drug currently holds approval to treat r/r acute lymphoblastic leukaemia (ALL) and r/r adult diffuse large B-cell lymphoma (DLBCL).
The single-arm, multi-centre, open-label ELARA trial is designed to assess the efficacy and safety of Kymriah in adults with r/r follicular lymphoma. It has enrolled patients from more than 30 sites in 12 countries globally.
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Based on preliminary data from the ELARA trial, the FDA awarded regenerative medicine advanced therapy (RMAT) designation to Kymriah in r/r follicular lymphoma in the second quarter of this year.
Novartis Global Drug Development head and chief medical officer John Tsai said: “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.
“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 company’s CAR-T manufacturing occurs at seven facilities across four continents. Commercial manufacturing of Kymriah is carried out at the Novartis facilities in Stein, Switzerland, Les Ulis, France, and Morris Plains, New Jersey, US.
Last month, Novartis reported that Jakavi (ruxolitinib) met the primary and key secondary endpoints in the Phase III REACH3 trial of patients with steroid-refractory or steroid-dependent chronic graft-versus-host disease (GvHD).