Axicabtagene ciloleucel achieved a complete metabolic response of 71% at 3 months versus 12% expected with standard of care among transplant ineligible patients with relapsed/refractory large B-cell lymphoma.
Results from the phase 2 ALYCANTE study showed that axicabtagene ciloleucel (Yescarta; Kite) demonstrated a high response rate and durable remission among transplant ineligible patients with relapsed/refractory large B-cell lymphoma (R/R LBCL) after 1 prior line of therapy who were deemed ineligible for high-dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT).
“Transplant ineligible patients with aggressive relapsed or refractory B-cell lymphomas face poor prognosis,” said Roch Houot, MD, PhD, head of the Haematology Department at the University Hospital of Rennes, France, and coordinator of the ALYCANTE study. “ALYCANTE is the first study to assess axicabtagene ciloleucel as second-line therapy for transplant ineligible R/R LBCL and the results showed high response rates and durable remission in this hard-to-treat population.”
Axicabtagene ciloleucel is a CD19-directed, genetically modified, autologous T cell immunotherapy indicated for the treatment of adults with LBCL that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. It is also indicated for adults with relapsed or refractory LBCL after 2 or more lines of systemic therapy.
ALYCANTE was a multicenter, open-label phase 2 study evaluating the efficacy and safety of axicabtagene ciloleucel as a second-line therapy in 62 patients with R/R LBCL who were ineligible for HDCT and ASCT. In clinical practice, approximately half of patients with R/R LBCL are deemed ineligible for HDCT or ASCT due to factors such as advanced age, frailty, and coexisting medical conditions. The ALYCANTE study included patients deemed ineligible for HDCT or ASCT because they were 65 years of age or older (88.7%), had a hematopoietic cell transplantation-specific comorbidity index score of 3 or greater (32.3%), and/or had received prior ASCT (3.2%).
The study met its primary endpoint with a complete metabolic response (CMR) of 71% at 3 months versus 12% expected with standard of care treatments. At 6 months, 59.7% of patients remained in CMR, defined as negative findings on a PET scan during or following antitumor therapy.
The best objective response (OR) and complete response (CR) rates were 91.9% and 82.3%, respectively. After a median follow-up of 12 months, median progression-free survival (PFS) from infusion was 11.8 months, and 48.8% of patients evaluated were alive and progression free at 12 months. Median overall survival (OS) was not reached and was 78.3% at 12 months.
Axicabtagene ciloleucel showed an acceptable safety profile in this population, with 8.1% and 14.5% of patients experiencing grade 3 to 4 cytokine release syndrome or immune effector cell associated neurotoxicity syndrome, respectively.
“For patients who are deemed ineligible for stem cell transplant, the ALYCANTE data demonstrate that Yescarta can provide another option for a potential curative therapy,” said Frank Neumann, MD, PhD, senior vice president and Kite’s Global Head of Clinical Development, in the press release. “The data generation for Yescarta continues to reaffirm its potential to bring hope to patients suffering from a variety of sub-types of large B-cell lymphoma and follicular lymphoma.”
Kite’s CAR T-cell Therapy Yescarta Demonstrates High Respnse Rate and Durable Remission in ALYCANTE Study as Initial Treatment for Transplant Ineligible Patients With Relapsed/Refractory Large B-cell Lymphoma. News release. Gilead. September 18, 2023. Accessed September 20, 2023. https://www.gilead.com/news-and-press/press-room/press-releases/2023/9/kites-car-t-cell-therapy-yescarta-demonstrates-high-response-rate-and-durable-remission-in-alycante-study-as-initial-treatment-for-transplant-inelig