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...
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| Hauptverfasser: | , , , , , , , , , , , , , , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
February 13 2025
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| In: |
Blood
Year: 2025, Jahrgang: 145, Heft: 7, Pages: 708-719 |
| ISSN: | 1528-0020 |
| DOI: | 10.1182/blood.2024025454 |
| Online-Zugang: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1182/blood.2024025454
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| Verfasserangaben: | Laurie H. Sehn, Nancy L. Bartlett, Matthew J. Matasar, Stephen J. Schuster, Sarit E. Assouline, Pratyush Giri, John Kuruvilla, Mazyar Shadman, Chan Yoon Cheah, Sascha Dietrich, Keith Fay, Matthew Ku, Loretta J. Nastoupil, Michael C. Wei, Shen Yin, Iris To, Derrick Kaufman, Antonia Kwan, Elicia Penuel, Christopher R. Bolen, and Lihua E. Budde |
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| 245 | 1 | 0 | |a Long-term 3-year follow-up of mosunetuzumab in relapsed or refractory follicular lymphoma after ≥2 prior therapies |c Laurie H. Sehn, Nancy L. Bartlett, Matthew J. Matasar, Stephen J. Schuster, Sarit E. Assouline, Pratyush Giri, John Kuruvilla, Mazyar Shadman, Chan Yoon Cheah, Sascha Dietrich, Keith Fay, Matthew Ku, Loretta J. Nastoupil, Michael C. Wei, Shen Yin, Iris To, Derrick Kaufman, Antonia Kwan, Elicia Penuel, Christopher R. Bolen, and Lihua E. Budde |
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| 520 | |a 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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| 700 | 1 | |a Bolen, Christopher R. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Budde, Lihua E. |e VerfasserIn |4 aut | |
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