Mosunetuzumab monotherapy is active and tolerable in patients with relapsed/refractory diffuse large B-cell lymphoma

Nancy L. Bartlett; Sarit Assouline; Pratyush Giri; Stephen J. Schuster; Chan Y. Cheah; Matthew Matasar; Gareth P. Gregory; Dok Hyun Yoon; Mazyar Shadman; Keith Fay; Sung Soo Yoon; Carlos Panizo; Ian Flinn; Anna Johnston; Francesc Bosch; Laurie H. Sehn; Michael C. Wei; Shen Yin; Iris To; Chi Chung Li; Huang Huang; Antonia Kwan; Elicia Penuel; Lihua E. Budde

doi:10.1182/bloodadvances.2022009260

Mosunetuzumab monotherapy is active and tolerable in patients with relapsed/refractory diffuse large B-cell lymphoma

Nancy L. Bartlett, Sarit Assouline, Pratyush Giri, Stephen J. Schuster, Chan Y. Cheah, Matthew Matasar, Gareth P. Gregory, Dok Hyun Yoon, Mazyar Shadman, Keith Fay, Sung Soo Yoon, Carlos Panizo, Ian Flinn, Anna Johnston, Francesc Bosch, Laurie H. Sehn, Michael C. Wei, Shen Yin, Iris To, Chi Chung LiHuang Huang, Antonia Kwan, Elicia Penuel, Lihua E. Budde

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Abstract

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.

Original language	English
Pages (from-to)	4926-4935
Number of pages	10
Journal	Blood Advances
Volume	7
Issue number	17
DOIs	https://doi.org/10.1182/bloodadvances.2022009260
State	Published - Sep 12 2023

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Bartlett, N. L., Assouline, S., Giri, P., Schuster, S. J., Cheah, C. Y., Matasar, M., Gregory, G. P., Yoon, D. H., Shadman, M., Fay, K., Yoon, S. S., Panizo, C., Flinn, I., Johnston, A., Bosch, F., Sehn, L. H., Wei, M. C., Yin, S., To, I., ... Budde, L. E. (2023). Mosunetuzumab monotherapy is active and tolerable in patients with relapsed/refractory diffuse large B-cell lymphoma. Blood Advances, 7(17), 4926-4935. https://doi.org/10.1182/bloodadvances.2022009260

@article{316943e38ebe4e978ce5e992f97ca106,

title = "Mosunetuzumab monotherapy is active and tolerable in patients with relapsed/refractory diffuse large B-cell lymphoma",

abstract = "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.",

author = "Bartlett, {Nancy L.} and Sarit Assouline and Pratyush Giri and Schuster, {Stephen J.} and Cheah, {Chan Y.} and Matthew Matasar and Gregory, {Gareth P.} and Yoon, {Dok Hyun} and Mazyar Shadman and Keith Fay and Yoon, {Sung Soo} and Carlos Panizo and Ian Flinn and Anna Johnston and Francesc Bosch and Sehn, {Laurie H.} and Wei, {Michael C.} and Shen Yin and Iris To and Li, {Chi Chung} and Huang Huang and Antonia Kwan and Elicia Penuel and Budde, {Lihua E.}",

year = "2023",

month = sep,

day = "12",

doi = "10.1182/bloodadvances.2022009260",

language = "English",

volume = "7",

pages = "4926--4935",

journal = "Blood Advances",

issn = "2473-9529",

number = "17",

}

Bartlett, NL, Assouline, S, Giri, P, Schuster, SJ, Cheah, CY, Matasar, M, Gregory, GP, Yoon, DH, Shadman, M, Fay, K, Yoon, SS, Panizo, C, Flinn, I, Johnston, A, Bosch, F, Sehn, LH, Wei, MC, Yin, S, To, I, Li, CC, Huang, H, Kwan, A, Penuel, E & Budde, LE 2023, 'Mosunetuzumab monotherapy is active and tolerable in patients with relapsed/refractory diffuse large B-cell lymphoma', Blood Advances, vol. 7, no. 17, pp. 4926-4935. https://doi.org/10.1182/bloodadvances.2022009260

TY - JOUR

T1 - Mosunetuzumab monotherapy is active and tolerable in patients with relapsed/refractory diffuse large B-cell lymphoma

AU - Bartlett, Nancy L.

AU - Assouline, Sarit

AU - Giri, Pratyush

AU - Schuster, Stephen J.

AU - Cheah, Chan Y.

AU - Matasar, Matthew

AU - Gregory, Gareth P.

AU - Yoon, Dok Hyun

AU - Shadman, Mazyar

AU - Fay, Keith

AU - Yoon, Sung Soo

AU - Panizo, Carlos

AU - Flinn, Ian

AU - Johnston, Anna

AU - Bosch, Francesc

AU - Sehn, Laurie H.

AU - Wei, Michael C.

AU - Yin, Shen

AU - To, Iris

AU - Li, Chi Chung

AU - Huang, Huang

AU - Kwan, Antonia

AU - Penuel, Elicia

AU - Budde, Lihua E.

PY - 2023/9/12

Y1 - 2023/9/12

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85171271553&partnerID=8YFLogxK

U2 - 10.1182/bloodadvances.2022009260

DO - 10.1182/bloodadvances.2022009260

M3 - Article

C2 - 37067952

AN - SCOPUS:85171271553

SN - 2473-9529

VL - 7

SP - 4926

EP - 4935

JO - Blood Advances

JF - Blood Advances

IS - 17

ER -

Mosunetuzumab monotherapy is active and tolerable in patients with relapsed/refractory diffuse large B-cell lymphoma

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