Kite’s CAR-T therapy Yescarta granted EC approval in second-line lymphoma

Kite, a Gilead company, has announced that the European Commission (EC) has granted approval for use of Yescarta (axicabtagene ciloleucel) as a second-line treatment in adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL).

The approval is specifically for patients who relapse within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy, and makes Yescarta the first chimeric antigen receptor (CAR) T-cell therapy approved for patients in Europe for this indication.

The EC’s decision is based on positive results from the pivotal phase 2 ZUMA-7 study which, as the company reports, is the ‘largest and longest’ trial of a CAR T-cell therapy versus standard of care (SOC) in this patient population.

The ZUMA-7 study demonstrated that at a median follow-up of two years, Yescarta-treated patients had a four-fold greater improvement in the primary endpoint of event-free survival (EFS) over the current SOC. Additionally, Yescarta demonstrated a 2.5 fold increase in patients who were alive at two years without disease progression or need for additional cancer treatment versus SOC.

Moreover, improvements in EFS with Yescarta were consistent across key patient subgroups, including elderly patients, primary refractory patients, HGBL, and double-expressor lymphoma patients.

“This approval marks a major shift in the treatment of LBCL when initial treatment has failed. In ZUMA-7, treatment with [Yescarta] resulted in an overall better outcome for patients than SOC, especially in terms of EFS, marking a new era for treatment earlier in the disease pathway for more patients,” said John Gribben, professor of medical oncology at the Cancer Research UK Barts Centre.

DLBCL is the most common subtype of non-Hodgkin lymphoma (NHL), representing around 30% of cases. HGBL is a recently introduced, rare subset of LBCL marked by aggressive B-cell lymphomas including tumours with Burkitt-like or blastoid tumours without double-hit characteristics.

Although first-line treatment can be effective in around 60% of newly diagnosed LBCL patients, including those with DLBCL, 40% will relapse or not respond and need second-line treatment, when outcomes are often poor.

Yescarta was first approved in Europe in 2018 and is now currently indicated for five types of blood cancer: DLBCL, LBCL, HGBL, primary mediastinal large B-cell lymphoma (PMBCL); and follicular lymphoma (FL).

“We are very proud to announce Kite’s fifth approved indication in Europe in our continued commitment to the research and delivery of cell therapies with curative potential to patients who might benefit around the world,” said Christi Shaw, chief executive officer, Kite.