Novartis has reported that Kymriah (tisagenlecleucel) failed to meet the primary goal of the Phase III BELINDA clinical trial in aggressive B-cell non-Hodgkin lymphoma (NHL) patients who relapsed or did not respond to first-line therapy.
Kymriah is a cluster of differentiation 19 (CD-19)-targeting genetically altered autologous T-cell immunotherapy.
Developed in partnership with the Perelman School of Medicine at the University of Pennsylvania, Kymriah is the first CAR-T cell therapy to obtain approval.
The global, randomised, open-label, multi-centre Phase III trial analysed the efficacy, safety and tolerability of Kymriah against standard-of-care (SOC) in patients enrolled at more than 73 sites in 18 countries.
Salvage chemotherapy was the SOC, which was followed by high-dose chemotherapy and hematopoietic stem cell transplant (HSCT) in responding subjects.
Data showed that the trial failed to meet its primary goal of event-free survival (EFS), determined as the time from randomisation to the first recorded disease progression or stable disease at or following the week 12 analysis or death at any time.
Novartis noted that Kymriah’s safety profile in the trial was in line with the previously reported data.
Novartis Oncology and Hematology Development global head Jeff Legos said: “Patients with aggressive B-cell non-Hodgkin lymphoma who are refractory to first-line treatment are vulnerable and we are disappointed that the BELINDA study did not meet its primary endpoint in this setting.
“Kymriah continues to demonstrate durable responses for patients with certain advanced blood cancers in the third-line setting.”
The company noted that Kymriah is efficacious in currently approved indications and provides the potential for lasting responses and a favourable safety profile in clinical and real-world settings in more than 5,300 people so far.
Earlier this year, Novartis reported that the primary analysis of the Phase II ELARA trial of Kymriah showed a complete response rate of 66% in relapsed or refractory follicular lymphoma patients.
The company is now working towards regulatory filings of the drug for follicular lymphoma in the second half of this year.
Cell & Gene Therapy Coverage on Clinical Trials Arena supported by Cytiva.
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