Gilead and Kite Oncology Announce Approval of Yescarta® for Early Treatment of DLBCL in Singapore

10 June 2024 | Monday | News

Based on Landmark ZUMA-7 Study, Patients with Diffuse Large B-cell Lymphoma (DLBCL) Treated with Axicabtagene Ciloleucel in Second-Line Achieved a Significant Improvement in Event-Free Survival versus Standard of Care (SOC)
Image Source : Public Domain

Image Source : Public Domain



**-- In ZUMA-7, Yescarta Patients with DLBCL were 2.5 Times More Likely than SOC to be Alive at Two Years Without Cancer Progression or Need for Additional Treatments --

Gilead and Kite Oncology announced that the Health Sciences Authority (HSA) has approved Yescarta® (axicabtagene ciloleucel) for the treatment of 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. This approval is based on results from the pivotal Phase 3 ZUMA-7 study, the largest and longest trial of a Chimeric Antigen Receptor (CAR) T-cell therapy versus SOC in this patient population.

“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. “This approval is welcome news to the clinical community and marks an important step in bringing this innovative therapy earlier to more patients in Singapore.”

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; hazard ratio 0.40; 95% CI: 0.31-0.51, P<0.001) over the current SOC (8.3 months vs 2.0 months). 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 vs SOC (41% vs 16%). Improvements in EFS with Yescarta were consistent across key patient subgroups, including elderly patients (HR: 0.28 [95% CI: 0.16-0.46]), primary refractory patients (HR: 0.43 [95% CI: 0.32-0.57]), high-grade B-cell lymphoma (HR: 0.28 [95% CI: 0.14-0.59]), and double-expressor lymphoma patients (HR: 0.42 [95% CI: 0.27-0.67]). Yescarta had a manageable safety profile that was consistent with previous studies.

“Today’s approval marks an important step towards that goal by providing patients in Singapore this option of CAR T-cell therapy earlier in their treatment journey,” said Diego Santoro, General Manager, Intercontinental Region, Kite. “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.”

The standard of care (SOC) to treat DLBCL patients has historically been a multi-step process that starts with chemoimmunotherapy, followed by high-dose chemotherapy (HDT), and then ends with a stem cell transplant (ASCT). Although approximately 60% of newly diagnosed LBCL patients will respond to the initial treatment with chemotherapy, 40% will relapse or will not respond and need second-line treatment


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