Serious and sometimes fatal adverse reactions occurred with LUNSUMIO treatment. Warnings and precautions include cytokine release syndrome, neurologic toxicity, infections, cytopenias, tumor flare, and embryo-fetal toxicity.
*From the initial occurrence of the documented PR or CR.
LUNSUMIO was studied across patient subgroups, including: age, refractory status, prior treatment, bulky disease, and FLIPI risk factors.
Limitations: These post hoc analyses were exploratory and no formal inference may be drawn.
Prior treatment type | ||
---|---|---|
Demographic | ORR | CR |
FLIPI ≥3 (n=40) | 83% | 60% |
Bulky disease (n=31) | 74% | 61% |
Refractory to last prior therapy (n=62) | 77% | 52% |
Refractory to any prior anti-CD20 therapy (n=71) | 77% | 55% |
Refractory to any prior anti-CD20 therapy and an alkylating agent (double refractory) (n=48) |
71% | 50% |
Refractory to any prior PI3K inhibitor (n=12) |
75% | 50% |
Prior rituximab-lenalidomide therapy (n=8) | 75% | 25% |
Prior CAR T-cell therapy (n=3) | 100% | 33% |
POD24 (n=47) | 85% | 57% |
EZH2 mutation (n=8) | 75% | 38% |
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3L+=third-line or later; auto-SCT=autologous stem cell transplant; CAR=chimeric antigen receptor; CI=confidence interval; CR=complete response; DOR=duration of response; FL=follicular lymphoma; FLIPI=Follicular Lymphoma International Prognostic Index; IRF=independent review facility; NE=not estimable; ORR=objective response rate; POD24=progression of disease within 24 months from the start of initial therapy; PR=partial response; Pts=patients.
LUNSUMIO. Prescribing Information. Genentech, Inc.
LUNSUMIO. Prescribing Information. Genentech, Inc.
FDA grants Breakthrough Therapy Designation for Roche’s CD20xCD3 bispecific cancer immunotherapy mosunetuzumab recognising its potential in follicular lymphoma. News release. July 14, 2020. Accessed December 17, 2021.
https://www.roche.com/investors/updates/inv-update-2020-07-14b.htm.
FDA grants Breakthrough Therapy Designation for Roche’s CD20xCD3 bispecific cancer immunotherapy mosunetuzumab recognising its potential in follicular lymphoma. News release. July 14, 2020. Accessed December 17, 2021.
https://www.roche.com/investors/updates/inv-update-2020-07-14b.htm.
Budde LE, Sehn LH, Matasar M, et al. Safety and efficacy of mosunetuzumab, a bispecific antibody, in patients with relapsed or refractory follicular lymphoma: a single-arm, multicentre, phase 2 study. Lancet Oncol. Published online July 5, 2022. doi:10.1016/S1470-2045(22)00335-7.
Budde LE, Sehn LH, Matasar M, et al. Safety and efficacy of mosunetuzumab, a bispecific antibody, in patients with relapsed or refractory follicular lymphoma: a single-arm, multicentre, phase 2 study. Lancet Oncol. Published online July 5, 2022. doi:10.1016/S1470-2045(22)00335-7.
Data on file. Genentech, Inc; 2022.
Data on file. Genentech, Inc; 2022.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas V.3.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed May 12, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas V.3.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed May 12, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org.
Sun LL, Ellerman D, Mathieu M, et al. Anti-CD20/CD3 T cell-dependent bispecific antibody for the treatment of B cell malignancies. Sci Transl Med. 2015;7(287):287ra70. doi:10.1126/scitranslmed.aaa4802.
Sun LL, Ellerman D, Mathieu M, et al. Anti-CD20/CD3 T cell-dependent bispecific antibody for the treatment of B cell malignancies. Sci Transl Med. 2015;7(287):287ra70. doi:10.1126/scitranslmed.aaa4802.
Ferl GZ, Reyes A, Sun LL, et al. A preclinical population pharmacokinetic model for anti-CD20/CD3 T-cell-dependent bispecific antibodies. Clin Transl Sci. 2018;11(3):296-304. doi:10.1111/cts.12535.
Ferl GZ, Reyes A, Sun LL, et al. A preclinical population pharmacokinetic model for anti-CD20/CD3 T-cell-dependent bispecific antibodies. Clin Transl Sci. 2018;11(3):296-304. doi:10.1111/cts.12535.
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