By Dr. Luke Fletcher
Willamette Valley Cancer Institute & Research Center
The Zuma 7 trial is a randomized, open-label multicenter study for patients with primary refractory Large b-cell lymphoma who were candidates for autologous stem cell transplantation.
Kite, a Gilead Company, just released an update from the Zuma 7 trial stating statistically significant overall survival benefit for yescarta (Axicabtagene ciloleucel or axi-cel) over second-line chemotherapy and autologous stem cell transplantation (1). Axi-cel is a genetically modified autologous anti-CD19 chimeric antigen receptor and was initially approved on October 18, 2017, for large B cell lymphoma after two or more lines of therapy based on the Zuma 1 data showing an 82% response rate, a complete response rate of 54%, and overall survival at 18 months of 52% (2,3). April 1, 2022, brought a bigger change with the approval for refractory large b cell lymphoma (refractory to first-line chemoimmunotherapy or relapse within 12 months) based on the initial results of the Zuma 7 trial (3,4).
The Zuma 7 trial is a randomized, open-label multicenter study for patients with primary refractory Large b-cell lymphoma who were candidates for autologous stem cell transplantation. The trial’s primary endpoint was event-free survival of 8.3 months in the axi-cel group and 2.0 months in the standard group, with 24-month event-free survival of 41% vs. 16%. Most recently, the overall survival data matured with the recent release of information showing statistically significant overall survival benefit, cementing its place as the best treatment second line in the refractory large cell lymphoma population. The full mature data is eagerly awaited to evaluate this exciting new finding fully.
- Kite’s Yescarta® CAR-T-Cell Therapy Demonstrates a Statistically Significant Improvement in Overall Survival for Initial Treatment of Relapsed/Refractory. Kite, a Gilead Company. LARGE B-CELL LYMPHOMA (Press release). 22 March 2023. Retrieved 22 March 2023
- Neelapu SS, Locke FL, Bartlett NL, et al. Axicabtagene Ciloleucel CAR T-Cell Therapy in Refractory Large B-Cell Lymphoma. N Engl J Med. 2017 Dec 28;377(26):2531-2544. doi: 10.1056/NEJMoa1707447. Epub 2017 Dec 10. PMID: 29226797; PMCID: PMC5882485
- Yescarta (axicabtagene ciloleucel)”. U.S. Food and Drug Administration (FDA). 4 November 2022. Retrieved 22 March 23.
- Locke FL, Miklos DB, Jacobson CA, et al. Axicabtagene Ciloleucel as Second-Line Therapy for Large B-Cell Lymphoma. N Engl J Med. 2022 Feb 17;386(7):640-654. doi: 10.1056/NEJMoa2116133. Epub 2021 Dec 11. PMID: 34891224.