A year or more after a single infusion of axicabtagene ciloleucel (Yescarta, Gilead Sciences), 42% of lymphoma patients continued to respond to therapy––including 40% with a complete remission.
Gilead’s Kite subsidiary announced long-term follow-up data from the pivotal ZUMA-1 study of axicabtagene in patients with refractory large B-cell lymphoma with a minimum follow-up of one year (median follow-up, 15.4 months). Detailed results from this updated analysis were presented at the annual meeting of the American Society of Hematology in Atlanta and published in The New England Journal of Medicine.
Axicabtagene is the first chimeric antigen receptor T (CAR T) cell therapy to be approved by the FDA for the treatment of adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. Yescarta is not indicated for patients with primary central nervous system lymphoma.
“As observed in the SCHOLAR-1 study, treatment options for patients with refractory large B-cell lymphoma have yielded a median overall survival of just six months, with fewer than 10% of patients achieving complete remission,” said Sattva S. Neelapu, MD, ZUMA-1 Co-Lead Investigator and Professor, Department of Lymphoma/Myeloma, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. “The durability of response seen with Yescarta in this long-term follow-up reinforces the major advance that CAR T therapy represents for these patients.”
In this updated analysis involving 108 patients in ZUMA-1 who had been followed for a minimum of one year, 82% of patients had responded to axicabtagene, including 58% who had achieved complete remission. At a median of 15.4 months post-infusion, 42% of patients remained in response, including 40% in complete remission. The median duration of response was 11.1 months (95% confidence interval [CI], 3.9 months to not estimable [NE]); in patients who have achieved a complete remission, the median duration of response was not reached (95% CI: NE). Median overall survival had not been reached (95% CI, 12 months to NE) with an overall survival rate at 18 months of 52% (95% CI, 41–62).
In the updated analysis, 12% of patients experienced grade 3 or higher cytokine release syndrome (CRS) and 31% experienced neurologic toxicities. The most common grade 3 or higher reactions were neutropenia (79%), anemia (45%), and thrombocytopenia (40%). Ten patients experienced a serious adverse event six months after axicabtagene infusion, including eight patients with infections. No new onset CRS or neurologic events related to axicabtagene were observed in the updated analysis.
Yescarta has a boxed warning in its product label and an associated Risk Evaluation and Mitigation Strategy regarding the risks of CRS and neurologic toxicities.
Yescarta is a CD19-directed genetically modified autologous T cell immunotherapy.
Source: Kite; December 10, 2017.