Yescarta FDA Label Updated to Include Overall Survival Data for Large B-Cell Lymphoma
Yescarta FDA Label Updated to Include Overall Survival Data for Large B-Cell Lymphoma
In early April 2024, the U.S. Food and Drug Administration (FDA) approved an updated prescribing information for Yescarta (Axicabtagene Ciloleucel) to include overall survival (OS) data in adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after first-line therapy containing Rituximab Injection and Anthracyclines.
Developed by Kite, a subsidiary of Gilead Sciences in the U.S., Yescarta is a CD19-directed genetically modified autologous T-cell immunotherapy indicated for the treatment of:
• Adult patients with large B-cell lymphoma (LBCL) that is refractory to or relapses within 12 months after first-line chemoimmunotherapy.
• Adult patients with relapsed or refractory LBCL after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
• Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
The updated label is based on data from the randomized, open-label, global, multicenter Phase 3 ZUMA-7 study (ClinicalTrials.gov Identifier: NCT03391466), which evaluated the efficacy of Axicabtagene Ciloleucel in 359 adults with relapsed or refractory LBCL. First-line therapy included Rituximab Injection and Anthracyclines. Participants were randomized 1:1 to receive a single infusion of Axicabtagene Ciloleucel (n=180) after fludarabine or bendamustine lymphodepleting chemotherapy or standard-of-care second-line therapy, including 2 or 3 cycles of chemoimmunotherapy, followed by high-dose therapy and autologous stem cell transplant in those achieving complete or partial response (n=179).
With an estimated median follow-up of 46.7 months, the results showed that treatment with Axicabtagene Ciloleucel reduced the risk of death by 27.4% compared with standard-of-care therapy (hazard ratio [HR], 0.73 [95% CI, 0.54-0.98; P=0.0168]). The estimated 39-month overall survival (OS) rate was 55.9% in the Axicabtagene Ciloleucel group and 46% in the standard-of-care group.
Based on earlier ZUMA-7 results, Axicabtagene Ciloleucel also demonstrated a statistically significant improvement in event-free survival (EFS; the primary endpoint) compared with standard-of-care therapy.
Additionally, the objective response rate was significantly higher in the Axicabtagene Ciloleucel group compared with the standard-of-care group.
“The label update for Yescarta in the U.S. for large B-cell lymphoma that has progressed or relapsed is an important step in bolstering healthcare provider confidence in treating eligible patients,” said Dr. Frank Neumann, Senior Vice President and Global Head of Clinical Development at Kite. “Our ZUMA-7 overall survival analysis demonstrates that when used as a second-line treatment, Yescarta provides an even greater survival benefit compared to standard of care. Combined with our rapid, reliable manufacturing, we hope to provide patients with the opportunity for a longer life.”
Overall, Yescarta is the first and only therapy in nearly 30 years to demonstrate superior overall survival compared to standard second-line care in patients with relapsed or refractory large B-cell lymphoma.