Axi-Cel Shows Efficacy in Patients With R/R LBCL Ineligible for ASCT


Around half of patients with R/R large B-cell lymphoma are considered ineligible for autologous stem cell transplant and are thus ineligible for the approved indication of Yescarta.

New data from the phase 2 ALYCANTE trial (NCT04531046) support the use of axicabtagene ciloleucel (axi-cel)for the treatment of patients with relapsed/refractory large B-cell lymphoma (R/R LBCL) ineligible for autologous stem cell transplant (ASCT).1

“Transplant ineligible patients with aggressive relapsed or refractory B-cell lymphomas face poor prognosis,” first author Prof. Roch Houot, head, Hematology Department, University Hospital of Rennes, France and coordinator of the ALYCANTE study, said in a statement.2 “ALYCANTE is the first study to assess axi-cel 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.”

Axi-cel is currently approved as Yescarta (Kite Pharma) for the second-line treatment of patients with R/R LBCL eligible for ASCT as well as patients with follicular lymphoma (FL) following 2 prior lines of therapy.3 However, Houot and colleagues pointed drew attention to the fact that in clinical practice, about half of patients with R/R LBCL are considered ineligible for high-dose chemotherapy/ASCT and these patients often have a poor prognosis with standard salvage chemotherapy.1

READ MORE: New Survival Data Cements Axi-Cel's Place as a Second-Line SOC for LBCL

ALYCANTE is a phase 2, open-label study that evaluated 62 patients with R/R LBCL ineligible for ASCT treated with axi-cel. The study met its primary endpoint with a complete metabolic response (CMR) rate of 71.0% (95% CI, 58.1-81.8) at 3 months. median follow-up of 12.0 months (range, 2.1–17.9), median progression-free survival was 11.8 months (95% CI, 8.4–not reached [NR]) and overall survival was not reached.1 Investigator-assessed overall response rate (ORR) was 75.8% (95% CI, 63.3-85.8) and 59.7% (n = 37) of patients remained in CMR at 6 months (95% CI, 46.5-72.0).

When assessed by a central review panel, CMR and ORR at 3 months were 66.1% (95% CI, 53.0–77.7) and 69.4% (95% CI, 56.4–80.4), respectively.1 Median progression-free survival from axi-cel infusion was 11.8 months (95% CI, 8.4–NR) and estimated PFS rates at 6 and 12 months were 67.7% (95% CI, 54.5–77.8) and 48.8% (95% CI, 34.0–62.0), respectively. Median overall survival from axi-cel infusion was not reached and estimated OS rates at 6 and 12 months were 91.9% (95% CI, 81.6–96.5) and 78.3% (95% CI, 64.7–87.1), respectively. Median duration of response was not reached. There were no unexpected toxicities, although grade 3–4 cytokine release syndrome and neurologic events occurred in 8.1% and 14.5% of patients, 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,” Frank Neumann, MD, PhD, senior vice president and global head, Clinical Development, Kite Pharma, added.2 “The data generation for Yescarta continues to reaffirm its potential to bring hope to patients suffering from a variety of sub-types of LBCL and FL.”

1. Houot R, Bachy E, Cartron G, et al. Axicabtagene ciloleucel in large B cell lymphoma ineligible for autologous stem cell transplantation: The phase 2 ALYCANTE trial. Nat Med (2023). doi: 10.1038/s41591-023-02572-5
2. Kite’s Car T-cell therapy Yescarta® demonstrates high response rate and durable remission in ALYCANTE study as initial treatment for transplant ineligible patients with relapsed/refractory large B-cell lymphoma. News release. Kite Pharma. September 18, 2023.
3. FDA approves axicabtagene ciloleucel for second-line treatment of large B-cell lymphoma. News release. FDA; April 1, 2022. Accessed Aprl 1, 2022.
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