Kite’s Yescarta Climbs Up To Treat Second-Line B-Cell Lymphomas After EC Nod

Kite’s anti-CD19 CAR T-cell therapy Yescarta (axicabtagene ciloleucel or axi-cel) has climbed up to the second-line treatment setting for diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) in Europe. 

The latest nod from the European Commission (EC) is Kite’s fifth and adds a new treatment option for the most common form of non-Hodgkin lymphoma. 40% of newly-diagnosed LBCL patients, including those with DLBCL, will relapse or will not respond to frontline treatment, and thus require second-line therapy, Kite said. 

Yescarta was first approved in Europe in 2018. It is currently indicated to treat five hematologic malignancies including DLBCL, LBCL, HBCL, primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma (FL). 

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Superiority Over Standard Of Care

The EU approval is supported by results from the Zuma-7 study showing Yescarta’s superiority over the standard of care (SOC) for second-line therapy of LBCL. SOC for this patient population starts with chemoimmunotherapy followed by high-dose chemotherapy and a stem cell transplant. 

In the Zuma-7 study, which enrolled 359 patients, Yescarta treatment improved event-free survival by fourfold while two-year survival (without disease progression) of treated patients is 41% compared to 16% under SOC. Yescarta-treated patients also reported improved quality of life at day 100 versus SOC. 

The safety profile of Yescarta in Zuma-7 was consistent with previous studies. Of the 170 treated patients, grade 3 or higher cytokine release syndrome and neurologic events were 6% and 21% respectively. 

This approval marks a major shift in the treatment of LBCL when initial treatment has failed, said Professor John Gribben, Professor of Medical Oncology at the Cancer Research UK Barts Centre, London. Besides showing better outcomes, the Zuma-7 results of Yescarta allow better management and prevention of side effects, which could benefit older patients and those who find the SOC less tolerable, he said.

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Joy Lin

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