Gilead and Kite Oncology's Yescarta receives approval for diffuse large B-cell Lymphoma treatment

It showed a four-fold improvement in event-free survival compared to the current standard of care.

Gilead Sciences and Kite Oncology have announced that Yescarta® (axicabtagene ciloleucel) has received approval from the Health Sciences Authority (HSA) for treating adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy.

The approval is based on the pivotal Phase 3 ZUMA-7 study, the largest trial comparing CAR T-cell therapy to standard of care in this patient group.

“The aggressive nature of DLBCL has presented an ongoing unmet treatment need for patients living with this blood cancer, as people who do not respond to, or fail after treatment, have a median overall survival of just six months,” said Dr. Lim Zi Yi, senior consultant in Haematology and medical director of Centre for Clinical Haematology, Singapore.

Yescarta showed a four-fold improvement in event-free survival compared to the current standard of care. Additionally, it showed a 2.5-fold increase in the number of patients alive at the two-year mark without disease progression or additional cancer treatment compared to the standard of care (41% vs. 16%). 

This improvement was consistent across various patient groups, including elderly patients, primary refractory patients, those with high-grade B-cell lymphoma, and individuals with double-expressor lymphoma. Moreover, Yescarta also maintained a manageable safety profile consistent with previous studies.

Diego Santoro, general manager - intercontinental region at Kite, said that Yescarta's approval marks a critical step forward in cancer treatment, providing patients with a more effective therapy option earlier in their treatment journey.

“For those facing the uncertainties and challenges of an aggressive lymphoma diagnosis in Singapore, this milestone offers the potential for survival and brings us one step closer to changing the way cancer is treated,” he said.

Traditionally, the standard of care for DLBCL patients involved a multi-step process, including chemoimmunotherapy, high-dose chemotherapy, and stem cell transplant. However, with approximately 40% of patients experiencing relapse or non-response, the need for innovative therapies like Yescarta is paramount in improving patient outcomes.