Treatment with axicabtagene ciloleucel resulted in improved survival and tumor responses in patients with relapsed/refractory follicular lymphoma versus other available therapies.
A comparative analysis of the ZUMA-5 (NCT03105336) and SCHOLAR-5 trials that was presented at the 2021 European Hematology Association (EHA) Virtual Conference demonstrated superiority of axicabtagene ciloleucel (Yescarta) over currently available therapies in patients with relapsed/refractory follicular lymphoma (R/R FL) based on objective response rate (ORR), progression-free survival (PFS), time to next treatment (TTNT), and overall survival (OS) data.
“ORR, [complete response], PFS and TTNT comparisons showed statistically significant improvements highlighting deep and durable treatment effect of axi-cel in this patient population,” said study author John Gribben, MD, DSc, a professor of medical oncology at Cancer Research UK Barts Centre, in a presentation of the findings.
Researchers sought to compare outcomes from an updated 18-month analysis of the ZUMA-5 trial to a matched sample of patients from the SCHOLAR-5 external control cohort.
The study authors analyzed 85 patients from the SCHOLAR-5 cohort, and 86 patients from ZUMA-5.
Patients included in this study had to have grade 1-2 R/R FL and have failed 2 or more previous lines of treatment as well as have an ECOG score of 0 or 1. After propensity score weighting, baseline characteristics in ZUMA-5 included a median age of 62 years (range, 34-79 years), 48 males (55.8%), 49 patients whose disease progressed within 24 months of first-line chemoimmunotherapy [POD24] (57%), 3.6 prior lines of treatment, 63 patients refractory to prior line (73.3%), 21 patients with a prior SCT (24.4%), 8.44 months since time of last treatment, 76.05 months since diagnosis, 51 patients with ECOG score of 0 (59.3%) and 35 patients with an ECOG score of 1 (40.7%).In SCHOLAR-5, the baseline characteristics included a median age of 61 years(range, 36-89 years), 53 males (61.9%), 47 POD24 patients (55.9%), 3.53 prior lines of treatment, 65 patients refractory to prior line of treatment (76.6%), 24 patients with a prior SCT (28%), 7.74 months since time of last treatment, 82.24 months since diagnosis, 21 patients with an ECOG score of 0 (29%) and 51 patients with an ECOG score of 1 (71%).
ORR among the patient population was substantially higher in the ZUMA-5 trial (94.2%) than in the SCHOLAR-5 trial (49.9%; OR = 16.24; 95% CI, 5.63-46.85; P < .0001). Moreover, complete responses were significantly improved in the ZUMA-5 cohort (79.1%) than in the SCHOLAR-5 cohort (29.9%; OR = 8.86; 95% CI, 4.3-18.25; P < .0001).
A median PFS was not reached in the cohort from ZUMA-5, whereas it was 12.68 months in the SCHOLAR-5 cohort (P < .001). Additionally, a median OS was not reached in the ZUMA-5 cohort; however, median OS in the SCHOLAR-5 cohort was 59.8 months (P = .0125).
“The substantial overall survival benefit seen in this study suggest that axi-cel addresses an important unmet medical need for relapsed/refractory follicular lymphoma patients,” said Gribben.
Median TTNT also significantly favored the ZUMA-5 cohort (not reached) over the SCHOLAR-5 cohort (14.43 months) (P < .001).
Of note, neither a median OS, PFS or TTNT were met in a primary and subgroup analysis of ZUMA-5.
“This data certainly supports that axi-cel represents a significant improvement in treatment options for patients with relapsed/refractory follicular lymphoma,” Gribben concluded.
Based on findings from the phase 2 ZUMA-5 trial, the FDA approved axi-cel for the treatment of this patient population in March 2021.
Ghione P, Patel A, Bobillo, S, et al. A comparison of clinical outcomes from ZUMA-5 (axicabtagene ciloleucel) and the international SCHOLAR-5 external control cohort in relapsed/refractory follicular lymphoma (R/R FL). Presented at: 2021 European Hematology Association Congress; June 9-17; Virtual. Abstract LB1904.