Mosunetuzumab 单药治疗在复发/难治性弥漫大 B 细胞淋巴瘤患者中有效且可耐受

As part of a phase 1 or 2 study, this single-arm expansion cohort established the efficacy and safety of mosunetuzumab monotherapy in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) (received 2 previous lines of therapy). Intravenous mosunetuzumab was administered with cycle (C) 1 step-up dosing for cytokine release syndrome (CRS) mitigation: C1 day (D) 1: 1 mg; C1D8 2 mg; C1D15 and C2D1: 60 mg; C3 + D1: 30 mg. Hospitalization was not mandatory.

Patients with complete response (CR) completed treatment after C8; those with partial response or stable disease continued treatment for a total of 17 cycles. The primary end point was CR rate (best response), assessed against a historical control CR rate (20%) by independent review facility. Eighty-eight patients (73. 9% de novo DLBCL; 26. 1% transformed follicular lymphoma) were enrolled; all had received previous anthracycline and anti-CD20 therapy.

Overall response and CR rates were 42. 0% (95% confidence interval [CI], 31. 6-53. 1) and 23. 9% (95% CI, 15. 4-34. 1), respectively; CR rate did not reach statistical significance vs the historical control (P = . 36). Median time to first response was 1. 4 months. Median progression-free survival was 3. 2 months (95% CI, 2. 2-5. 3). The CR rate in 26 patients who received previous chimeric antigen receptor T-cell (CAR-T) therapy was 12%.

CRS was one of the most common adverse events (26. 1% of patients); predominantly grade 1 to 2 and primarily in C1. Four patients (4. 5%) discontinued mosunetuzumab owing to adverse events. Mosunetuzumab demonstrated notable efficacy and a manageable safety profile in patients with R/R DLBCL, including those previously treated with CAR-Ts. This trial was registered at www. clinicaltrials. gov as #NCT02500407.