Long-term 3-year follow-up of mosunetuzumab in relapsed or refractory follicular lymphoma after ≥2 prior therapies

Mosunetuzumab, a CD20×CD3 T-cell engaging bispecific antibody, redirects T cells to eliminate malignant B cells. We present updated efficacy and safety data of a pivotal phase 1/2 study after a median follow-up of 37.4 months in 90 patients with relapsed/refractory (R/R) follicular lymphoma (FL) and ≥2 prior lines of therapy treated with fixed-duration mosunetuzumab. Investigator-assessed complete response (CR) rate and objective response rate were 60.0% (95% confidence interval [CI], 49.1-70.2) and 77.8% (95% CI, 67.8-85.9), respectively. Among 70 responders, median duration of response was 35.9 months (95% CI, 20.7 to not estimable [NE]). Among 54 patients who achieved CR, 49 remained in CR at the end of treatment; median duration of CR was not reached (NR; 95% CI, 33.0 to NE); Kaplan-Meier-estimated 30-month remission rate was 72.4% (95% CI, 59.2-85.6). Estimated 36-month overall survival (OS) rate was 82.4% (95% CI, 73.8-91.0); median OS was NR (95% CI, NE to NE). Median progression-free survival was 24.0 months (95% CI, 12.0 to NE). Median time to CD19+ B-cell recovery was 18.4 months (95% CI, 12.8-25.0) after 8 cycles of mosunetuzumab treatment. No new cytokine release syndrome events or fatal, serious, or grade ≥3 adverse events were reported. With extended follow-up, mosunetuzumab demonstrated high response rates, durable remissions, and manageable safety with no long-term concerns. This supports outpatient mosunetuzumab administration as an off-the-shelf, fixed-duration, safe, and effective treatment for patients with R/R FL, including those with high-risk disease. This trial was registered at www.clinicaltrials.gov as #NCT02500407.

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Journal
Blood
Published
2024-10-24
DOI
https://doi.org/10.1182/blood.2024025454
Citations
56
Primary Topic
CAR-T cell therapy research
Type
article
Field-Weighted Citation Impact
15.82

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article

Long-term 3-year follow-up of mosunetuzumab in relapsed or refractory follicular lymphoma after ≥2 prior therapies

Laurie H. Sehn, Loretta J. Nastoupil, Keith Fay, Matthew J. Matasar et al.
56 citations
Blood
CAR-T cell therapy research
15.82
article

Long-term 3-year follow-up of mosunetuzumab in relapsed or refractory follicular lymphoma after ≥2 prior therapies

Laurie H. Sehn, Loretta J. Nastoupil, Keith Fay, Matthew J. Matasar, Mazyar Shadman, Sascha Dietrich, Michael C. Wei, Chan Yoon Cheah, Sarit Assouline, Antonia Kwan, Nancy L. Bartlett, Matthew Ku, Stephen J. Schuster, Lihua E. Budde, John Kuruvilla, Christopher R. Bolen, Elicia Penuel, Shen Yin, Derrick Kaufman, Pratyush Giri, Iris To
article en
56 citations

Abstract

Mosunetuzumab, a CD20×CD3 T-cell engaging bispecific antibody, redirects T cells to eliminate malignant B cells. We present updated efficacy and safety data of a pivotal phase 1/2 study after a median follow-up of 37.4 months in 90 patients with relapsed/refractory (R/R) follicular lymphoma (FL) and ≥2 prior lines of therapy treated with fixed-duration mosunetuzumab. Investigator-assessed complete response (CR) rate and objective response rate were 60.0% (95% confidence interval [CI], 49.1-70.2) and 77.8% (95% CI, 67.8-85.9), respectively. Among 70 responders, median duration of response was 35.9 months (95% CI, 20.7 to not estimable [NE]). Among 54 patients who achieved CR, 49 remained in CR at the end of treatment; median duration of CR was not reached (NR; 95% CI, 33.0 to NE); Kaplan-Meier-estimated 30-month remission rate was 72.4% (95% CI, 59.2-85.6). Estimated 36-month overall survival (OS) rate was 82.4% (95% CI, 73.8-91.0); median OS was NR (95% CI, NE to NE). Median progression-free survival was 24.0 months (95% CI, 12.0 to NE). Median time to CD19+ B-cell recovery was 18.4 months (95% CI, 12.8-25.0) after 8 cycles of mosunetuzumab treatment. No new cytokine release syndrome events or fatal, serious, or grade ≥3 adverse events were reported. With extended follow-up, mosunetuzumab demonstrated high response rates, durable remissions, and manageable safety with no long-term concerns. This supports outpatient mosunetuzumab administration as an off-the-shelf, fixed-duration, safe, and effective treatment for patients with R/R FL, including those with high-risk disease. This trial was registered at www.clinicaltrials.gov as #NCT02500407.

BloodVol. 145(7)
Rutgers, The State University of New Jersey (US), BC Cancer Agency (CA), City Of Hope National Medical Center (US), Royal Adelaide Hospital (AU), Amgen (United States) (US), The University of Texas MD Anderson Cancer Center (US), The University of Western Australia (AU), Washington University in St. Louis (US), Heidelberg University (DE), Royal North Shore Hospital (AU), Jewish General Hospital (CA), Spinal Cord Injury BC (CA), University Hospital Heidelberg (DE), Sir Charles Gairdner Hospital (AU), Princess Margaret Cancer Centre (CA), St Vincent's Hospital Melbourne (AU), Düsseldorf University Hospital (DE), Fred Hutch Cancer Center (US), UPMC Hillman Cancer Center (US), Rutgers Cancer Institute (US), Central Adelaide Local Health Network, Heinrich Heine University Düsseldorf (DE), University of Pennsylvania (US)
Amgen, Bristol-Myers Squibb, Eli Lilly and Company, Pfizer, AstraZeneca, Gilead Sciences, Teva Pharmaceutical Industries, Celgene, F. Hoffmann-La Roche, TG Therapeutics, MEI Pharma, BeiGene, Incyte, Royal Adelaide Hospital, MorphoSys, Genentech, Kite Pharma, Pharmacyclics, Janssen Research and Development, Daiichi Sankyo Europe
Good health and well-being
Openalex Percentile: Top 1%
CAR-T cell therapy research
15.82
DOIOpen Access PDFOpenAlex
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