Summary

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• This summary is based on the review of three randomized controlled trial(s). ^[1-3]
• In patients with relapsed or refractory follicular lymphoma, the overall response rate (ORR) was 82.0% (95% confidence interval (CI), 74.3 to 88.3), with a complete response rate (CRR) of 62.5% (95% CI, 53.5 to 70.9). Among adults with relapsed or refractory Cluster of Differentiation 20-positive (CD20+) large B-cell lymphoma, the ORR was 63.1% (95% CI, 55.0 to 70.6), and the CRR was 38.9% (95% CI, 31.2 to 46.9).
• In adults with relapsed or refractory diffuse large B-cell lymphoma, the ORR at full doses was 68% (95% CI: 45-86) and the CRR was 45%. In patients with relapsed or refractory follicular lymphoma, the ORR was 90% (95% CI: 55-100), with a CRR of 50%.
• Across studies, high response rates were observed regardless of lymphoma subtype, with notable effectiveness in both diffuse large B-cell lymphoma and follicular lymphoma subgroups, providing promising outcomes in heavily pretreated patients.
• In patients with relapsed or refractory follicular lymphoma, common adverse events included grade 3-4 neutropenia (25%), grade 1-2 cytokine release syndrome (CRS) (65%), and immune effector cell-associated neurotoxicity syndrome (ICANS) (6%). In the cycle 1 optimization cohort, CRS incidence was reduced to 49%, with no cases of grade 3 or higher CRS.
• In adults with relapsed or refractory CD20(+) large B-cell lymphoma, CRS occurred in 49.7% of patients (grade 3: 2.5%) and ICANS in 6.4% of patients, including one fatal ICANS event.
• Document 1 included a subgroup analysis of patients with relapsed or refractory follicular lymphoma, showing that the cycle 1 optimization cohort (median age 64 years) had reduced CRS severity. Document 2 examined adults with relapsed or refractory CD20(+) large B-cell lymphoma, including 38.9% with prior CAR T-cell exposure, demonstrating consistent effectiveness and safety outcomes across these subgroups. Document 3 provided specific efficacy results for diffuse large B-cell lymphoma and follicular lymphoma subgroups, showing high overall response rates.