Huang, H. (Huang)

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    Mosunetuzumab monotherapy is active and tolerable in patients with relapsed/refractory diffuse large B-cell lymphoma
    (2023) Li, C. (Chi-Chung); Assouline, S. (Sarit); Kwan, A. (Antonia); Budde, L.E. (Lucia E.); To, I. (Iris); Giri, P. (Pratyush); Huang, H. (Huang); Panizo, C. (Carlos); Schuster, S.J. ( Stephen J.); Sehn, L.H. (Laura H.); Flinn, I. (Ian); Peñuel, E. (Elicia); Bosch, F. (Francesc); Gregory, G.P. (Gareth P.); Fay, K. (Keith); Yin, S. (Shen); Matasar, M. (Matthew); Cheah, C. Y. ( Chan Y.); Yoon, S. (Sung-Soo); Johnston, A. (Anna); Yoon, D.H. (Dok Hyun); Shadman, M. (Mazyar); Bartlett, N.L. (Nancy L.); Wei, M.C. (Michael C.)
    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.