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

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.”

REFERENCES

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. https://www.businesswire.com/news/home/20230918662167/en/Kite%E2%80%99s-Car-T-cell-Therapy-Yescarta%C2%AE-Demonstrates-High-Response-Rate-and-Durable-Remission-in-ALYCANTE-Study-as-Initial-Treatment-for-Transplant-Ineligible-Patients-With-RelapsedRefractory-Large-B-cell-Lymphoma
3. FDA approves axicabtagene ciloleucel for second-line treatment of large B-cell lymphoma. News release. FDA; April 1, 2022. Accessed Aprl 1, 2022. https://bit.ly/3iSQ8XT