ALYCANTE: Axi-cel exhibits favorable results in the treatment of patients with LBCL

Axicabtagene ciloleucel (axi-cel) exhibits high response rates and durable remission in the ALYCANTE study (NCT04531046) as an initial treatment for patients with relapsed/refractory large B-cell lymphoma (LBCL) who are ineligible for autologous stem cell transplantation (ASCT) and high-dose chemotherapy (HDCT), and had received one prior line of therapy.¹

The ALYCANTE study is a multicenter, phase II Lymphoma Study Association (LYSA) study which was previously summarized by the Lymphoma Hub.¹ The study included patients (n = 62 who were declared ineligible for HDCT/ASCT due to age ≥65 years (88.7%), a high hematopoietic cell transplantation-specific comorbidity index score ≥3 (32.3%), and/or a history of ASCT (3.2%) The study met its primary endpoint with a high complete metabolic response in patients treated with axi-cel versus standard of care (Figure 1). After a 6-month follow-up, 59.7% of patients treated with axi-cel remained in complete metabolic response. The best objective response was 91.9% and the complete response rate was 82.3%.¹

Axi-cel, axicabtagene ciloleucel.
*Data from Business Wire.¹

 After 12-months of follow-up:

• Median progression-free survival was 11.8 months (95% confidence interval, 8.4–not reached)²
• Median overall survival was not reached¹
• Overall survival at 12 months was 78.3%.¹

Axi-cel treatment was found to be safe in this population who are considered unfit for HDCT/ASCT. There were no unexpected toxicities and adverse events reported at Grade 3–4 were cytokine release syndrome (8.1%) or immune effector cell-associated neurotoxicity (14.5%).¹ Together, these results support the use of axi-cel as second-line therapy in patients with relapsed/refractory LBCL who are ineligible for ASCT.^1,2