Current Edition

Novartis’ Kymriah fails to hit primary survival endpoint in late-stage trial

The Phase III Belinda study investigating Kymriah (tisagenlecleucel) for treatment of non-Hodgkin lymphoma did not meet its primary endpoint of event-free survival compared to treatment with the standard-of-care (SOC), Novartis has announced.

The trial was investigating Kymriah in aggressive B-cell non-Hodgkin lymphoma (NHL) patients who had primary refractory disease or who relapsed within 12 months of first-line treatment.

“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,” said Jeff Legos, executive vice president, global head of oncology & haematology development.

“Kymriah continues to demonstrate durable responses for patients with certain advanced blood cancers in the third-line setting. We remain committed to accelerating development of Kymriah and our next-generation CAR-Ts and anticipate sharing early clinical results for these therapies at an upcoming medical meeting,” he added.

Kymriah is currently approved for the treatment of relapsed or refractory paediatric and young adult acute lymphoblastic leukaemia adult diffuse large B-cell lymphoma (DLBCL).