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    Lunsumio (mosunetuzumab-axgb)

    Prescribing Information

    Safety Data Sheet:

    LUNSUMIO® Vials 1 mg/1 mL
    LUNSUMIO® Vials 30 mg/30 mL

    Healthcare Provider Letters:

    Important Drug Warning - August 2024
    Product-Related Information Publications and Congresses
    Product-Related Information icon

    Product-Related Information

    SAFETY INFORMATION

    Study Design
    Safety Profile
    CRS Profile
    CRS Management
    Abbreviations

    The information in this section may include content beyond what is in the FDA-approved label. Because the FDA has not approved such content, no conclusions regarding safety or efficacy may be made. Providing this information should not be construed as recommendation for use of a Genentech product for unapproved uses. For FDA-approved products please consult the product’s full prescribing information for a complete discussion of risks and benefits of the product(s) for its approved indication(s).

    WARNING: CYTOKINE RELEASE SYNDROME
    See full prescribing information for complete boxed warning.

    Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving LUNSUMIO. Initiate treatment with the LUNSUMIO step-up dosing schedule to reduce the risk of CRS. Withhold LUNSUMIO until CRS resolves or permanently discontinue based on severity. (2.1, 2.4, 5.1)

    SAFETY INFORMATION

    Study Design

    Phase 2 Trial of LUNSUMIO (mosunetuzumab-axgb) for Patients with Relapsed/Refractory Follicular Lymphoma (R/R FL) after ≥2 prior lines of therapy1,2

    • Open-label, multicenter, multicohort study
    • LUNSUMIO is administered as a fixed-duration treatment with Cycle 1 step-up dosing to mitigate the risk of cytokine release syndrome (CRS)2
    • There was no mandatory hospitalization for treatment initiation2,a
    • Efficacy was established on the basis of objective response rate (ORR) and duration of response (DoR) as assessed by an independent review facility (IRF) according to standard criteria for non-Hodgkin lymphoma (NHL)1,3,b

    Eligibility Criteria and Endpoints

    FL Cohort Key Eligibility Criteria2

    • FL (Grades 1-3a)
    • Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1
    • ≥2 prior regimens, including:
      • ≥1 anti-CD20 antibody (Ab)
      • ≥1 alkylating agent

    Primary Endpoint2

    • Complete response (CR, best response) rate by IRF
      • Assessed vs 14% historical control CR rate4,b

    Secondary Endpoint2

    • ORR
    • DoR
    • Progression-free survival (PFS)
    • Safety and tolerability
      • The GO29781 study protocol provided guidance on the management of cytokine release syndrome (CRS), neurotoxicity, infections, cytopenias, and tumor flare

    LUNSUMIO Intravenous (IV)2 (N=90)

    Footnotes

    1. Hospitalization is recommended for subsequent infusions if a Grade 3 CRS event occurs and may be needed to manage select adverse events (AEs) in some patients5
    2. Assessed by computed tomography (CT) and positron-emission tomography-CT (PET-CT) using Cheson 2007 criteria2,4
    3. Unless patients experienced progressive disease or unacceptable toxicity1

    References

    1. LUNSUMIO [prescribing information]. South San Francisco, CA: Genentech, Inc. 2022.
    2. Budde LE et al. Lancet Oncol. 2022;23(8):1055-1065.
    3. Cheson BD et al. J Clin Oncol. 2007;25(5):579-586.
    4. Dreyling MH et al. J Clin Oncol. 2017;35(35):3898-3905.
    5. Data on file. Genentech, Inc. 2022.
    Abbreviations

    Safety Profile

    Safety Results1

    N (%) N=90
    AE 90 (100%)
    LUNSUMIO-relateda 83 (92.2%)
    Grade 3-4 AE 63 (70.0%)
    LUNSUMIO-relateda 46 (51.1%)
    Serious Adverse Event (SAE) 42 (46.7%)
    LUNSUMIO-relateda 30 (33.3%)
    Grade 5 (fatal) AE 2 (2.2%)b
    LUNSUMIO-relateda 0
    AE leading to discontinuation of treatment 4 (4.4%)c
    LUNSUMIO-relateda 2 (2.2%)c

    By Grade and Relationship

    AEs (≥15%) with LUNSUMIO (mosunetuzumab-axgb)

    Note

    *Safety data reflects the Phase 2 trial population in 3L+ FL (n=90); the United States Prescribing Information (USPI) also includes data from the pooled safety population in patients with hematologic malignancies (n=218).

    Footnotes

    1. AE considered related to treatment by the investigator
    2. LUNSUMIO-unrelated: malignant neoplasm progression and unexplained death (1 patient each)
    3. LUNSUMIO-related: CRS (2 patients); LUNSUMIO-unrelated: Epstein-Barr viremia and Hodgkin’s disease (1 patient each)

    References

    1. Budde LE et al. Presented at American Society of Hematology Annual Meeting; Virtual; December 11-14, 2021. Oral presentation #IBCL-249.
    Abbreviations

    Other AEs of Interest

    N (%) N=90 Additional details
    Neutropenia
    Neutropenia (any grade)a 26 (28.9%)
    • 98.1% resolved
    • SAE of infection concurrent with Grade 3-4 neutropenia in 2 patients
    Grade 3-4 24 (26.7%)
    Febrile neutropenia 0
    SAE of infection
    SAE of infection (any grade)b 18 (20.0%)
    • UTI (3.3%), pneumonia, COVID-19, Epstein-Barr viremia, septic shock (2.2% each)
    Grade 3-4 13 (14.4%)

    Footnotes

    1. Grouped term including preferred term “neutropenia” and “neutrophil count decreased”
    2. System organ class “infections and infestations”

    Reference

    1. Budde LE et al. Presented at: American Society of Hematology Annual Meeting; Virtual; December 11-14, 2021. Oral presentation #IBCL-249.
    Abbreviations

    Recommendations for Management of Neurologic Toxicity (Including ICANS)1

    At the first sign of neurologic toxicity, including ICANS, withhold LUNSUMIO (mosunetuzumab-axgb) and consider neurology evaluation. Rule out other causes of neurologic symptoms. Provide supportive therapy, which may include intensive care.1

    Adverse Reaction1: Neurologic Toxicitya (including ICANSb)

    Severitya,b

    Grade 2

    Actions

    • Withhold LUNSUMIO until neurologic toxicity symptoms improve to Grade 1 or baseline for at least 72 hoursc
    • Provide supportive therapy. If ICANS, manage per current practice guidelines

    Severitya,b

    Grade 3

    Actions

    • Withhold LUNSUMIO until neurologic toxicity symptoms improve to Grade 1 or baseline for at least 72 hoursc
    • Provide supportive therapy, which may include intensive care, and consider neurology evaluation. If ICANS, manage per current practice guidelines
    • If recurrence, permanently discontinue LUNSUMIO

    Severitya,b

    Grade 4

    Actions

    • Permanently discontinue LUNSUMIO
    • Provide supportive therapy, which may include intensive care, and consider neurology evaluation. If ICANS, manage per current practice guidelines

    Additional Details of ICANS Events

    N (%)2 N=90 Additional details
    ICANSd 4 (4.4%)
    • Confusional state (3.3%; all Grade 1-2e), disturbance in attention and cognitive disorder (1.1% each; all Grade 1e); all resolved
    • No cases of aphasia, seizures, encephalopathy, or cerebral edema
    Grade 3 0
    • ICANS events were infrequent and all Grade 1-2

    Footnotes

    1. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0
    2. Based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for ICANS
    3. See Table 2 in the USPI for recommendations on restarting LUNSUMIO after dose delays [see Dosage and Administration (2.2)]
    4. Mosunetuzumab-related neurological AEs potentially consistent with ICANS
    5. Graded per CTCAE V4

    References

    1. LUNSUMIO [prescribing information]. South San Francisco, CA: Genentech, Inc. 2022.
    2. Budde LE, 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. 2022 Aug;23(8):1055-1065.
    Abbreviations

    CRS Profile

    Incidence of CRS1,a (n=90)

    CRS was predominantly Grade 1 and 21

    Footnotes

    1. Assessed using ASTCT criteria2
    2. Patient with leukemic phase FL1

    References

    1. Budde LE et al. Lancet Oncol. 2022;23(8):1055-1065.
    2. LUNSUMIO [prescribing information]. South San Francisco, CA: Genentech, Inc. 2022.
    Abbreviations

    CRS by Cycle and Grade (n=90)1-3

    CRS most commonly occurred after the cycle 1, day 1 dose (at the first dose of LUNSUMIO 1 mg) and after the cycle 1, day 15 dose (after the highest dose of LUNSUMIO 60 mg)1,2

    1. LUNSUMIO [prescribing information]. South San Francisco, CA: Genentech, Inc. 2022.
    2. Budde LE et al. Lancet Oncol. 2022;23(8):1055-1065.
    3. Data on file. Genentech, Inc. 2022.
    Abbreviations

    Symptoms of Patients Who Experienced CRS1 (n=40)

    Pyrexia
    Hypotension
    Chills
    Headache
    Tachycardia
    Hypoxia
    1. Budde LE et al. Lancet Oncol. 2022;23(8):1055-1065.
    Abbreviations

    CRS Management

    Per ASTCT 2019 Grading in the LUNSUMIO (mosunetuzumab-axgb) USPI1

    Grade and Presenting Symptomsa

    Grade 1

    Fever >100.4°F (38° C)c

    Actionsb

    • Withhold current infusion of LUNSUMIO and manage per current practice guidelines
      • If symptoms resolve, restart infusion at the same rate
    • Ensure CRS symptoms are resolved for at least 72 hours prior to the next dose of LUNSUMIOd
    • Administer premedicatione prior to the next dose of LUNSUMIO and monitor patient more frequently

    Grade and Presenting Symptomsa

    Grade 2

    Fever ≥100.4°F (38°C)c with

    • Hypotension not requiring vasopressors

    and/or

    • Hypoxia requiring low-flow oxygenf by nasal cannula or blow-by

    Actionsb

    • Withhold current infusion of LUNSUMIO and manage per current practice guidelines
      • If symptoms resolve, restart infusion at 50% rate
    • Ensure CRS symptoms are resolved for at least 72 hours prior to the next does of LUNSUMIOd
    • Administer premedicatione prior to next dose of LUNSUMIO and consider infusing the next dose at 50% rate
    • For the next dose of LUNSUMIO, monitor more frequently and consider hospitalization

    Recurrent Grade 2 CRS

    • Manage per Grade 3 CRS

    Grade and Presenting Symptomsa

    Grade 3

    Fever ≥100.4°F (38°C)c with

    • Hypotension requiring a vasopressor (with or without vasopressin) and/or

    and/or

    • Hypoxia requiring high-flow oxygenf by nasal cannula, face mask, nonrebreather mask, or Venturi mask

    Actionsb

    • Withhold LUNSUMIO, manage per current practice guidelines, and provide supportive therapy, which may include intensive care
    • Ensure CRS symptoms are resolved for at least 72 hours prior to the next dose of LUNSUMIOd
    • Administer premedicatione prior to the next dose of LUNSUMIO and infuse the next dose at 50% rate
    • Hospitalize for the next dose of LUNSUMIO

    Recurrent Grade 3 CRS

    • Permanently discontinue LUNSUMIO
    • Manage CRS per current practice guidelines and provide supportive therapy, which may include intensive care

    Grade and Presenting Symptomsa

    Grade 4

    Fever ≥100.4°F (38°C)c with

    • Hypotension requiring multiple vasopressors (excluding vasopressin)

    and/or

    • Hypoxia requiring oxygen by positive pressure (eg, continuous positive airway pressure, bilevel positive airway pressure, intubation, and mechanical ventilation)

    Actionsb

    • Permanently discontinue LUNSUMIO
    • Manage CRS per current practice guidelines and provide supportive therapy, which may include intensive care

    Footnotes

    1. Based on ASTCT 2019 grading for CRS
    2. If CRS is refractory to management, consider other causes, including hemophagocytic lymphohistiocytosis
    3. Premedication may mask fever; therefore, if clinical presentation is consistent with CRS, follow these management guidelines
    4. Refer to full Prescribing Information for additional information on premedication
    5. Refer to full Prescribing Information for information on restarting LUNSUMIO after dose delays [see Dosage and Administration (2.2)]
    6. Low-flow oxygen defined as oxygen delivered at <6 L/minute; high-flow oxygen defined as oxygen delivered at ≥6 L/min.

    Reference

    1. LUNSUMIO [prescribing information]. South San Francisco, CA: Genentech, Inc. 2022. ​
    Abbreviations

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    Publications and Congresses

    The information in this section may include content beyond what is in the FDA-approved label. Because the FDA has not approved such content, no conclusions regarding safety or efficacy may be made. Providing this information should not be construed as recommendation for use of a Genentech product for unapproved uses. For FDA-approved products please consult the product’s full prescribing information for a complete discussion of risks and benefits of the product(s) for its approved indication(s).

    Publications: The list of publications is not an exhaustive list of published materials on the product. The list of references by data topics is selected per evidence-based medicine criteria. To browse a full listing of published scientific literature:

    Visit PubMed

    Congresses: The list of congresses is a subset of Roche/Genentech posters and oral presentations for the product with data presented at scientific meetings in the recent 24 months. To browse full Roche/Genentech congress presentations and posters:

    Visit Medically

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    • 9HPT
      9-hole peg test

    • AAAAI
      American Academy of Allergy Asthma & Immunology

    • AAN
      American Academy of Neurology

    • ABC
      activated B-cell–like subtype

    • AE
      Adverse event

    • Ang2
      Angiopoietin-2

    • ARR
      Annualized Relapse Rate

    • ART
      Assisted Reproductive Technology

    • ASTCT
      American Society for Transplantation and Cellular Therapy

    • ATG
      Anti-thymocyte globulin

    • AUC
      area under the serum concentration–time curve

    • CALs
      chronic active lesions

    • CAR
      Chimeric antigen receptor

    • cCDP
      composite clinical disease progression

    • CCOD
      clinical cut-off date

    • CD3
      Cluster of differentiation 3

    • CD4
      Cluster of differentiation 4

    • CD8
      Cluster of differentiation 8

    • CD19
      Cluster of differentiation 19

    • CD20
      Cluster of differentiation 20

    • CD226
      Cluster of differentiation 226

    • CDA
      confirmed disability accumulation

    • CDC
      Centers for Disease Control and Prevention

    • CDP
      clinical disease progression

    • CI
      Confidence Interval

    • CIS
      clinically isolated syndrome

    • Cmax
      maximum serum concentration

    • COVID-19
      Coronavirus disease of 2019

    • CNS
      central nervous system

    • CPAP
      Continuous positive airway pressure

    • CR
      Complete response

    • CRP
      C-reactive protein

    • CRS
      Cytokine release syndrome

    • CSF
      cerebrospinal fluid

    • CT
      Computed tomography

    • CTCAE
      Common Terminology Criteria for Adverse Events

    • DIC
      Disseminated intravascular coagulation

    • DLBCL
      Diffuse large B-cell lymphoma

    • DMT
      Disease-modifying therapy

    • DMT
      Disease-modifying treatment

    • DoCR
      Duration of complete response

    • DoR
      Duration of response

    • DBPCFC
      Double-blind, placebo-controlled food challenge

    • ECOG PS
      Eastern Cooperative Oncology Group performance status

    • ECTRIMS
      European Committee for Treatment and Research in Multiple Sclerosis

    • EDSS
      Expanded Disability Status Scale

    • EFSefficacy
      event-free survival for efficacy causes (time from randomization to the earliest occurrence of disease progression/relapse, death due to any cause, initiation of any non-protocol specified anti-lymphoma treatment, or biopsy-confirmed residual disease after treatment completion)

    • EMA
      European Medicines Association

    • EOT
      end of treatment

    • EPIC
      expression/genomics, proteomics, imaging, and clinical

    • FAERS
      FDA Adverse Event Reporting System

    • FDA
      Food and Drug Administration

    • FDA
      US Food and Drug Administration

    • FL
      Follicular lymphoma

    • GCB
      germinal-center B-cell–like subtype

    • Gd
      gadolinium-enhanced

    • Gd+
      gadolinium-enhancing

    • GFAP
      glial fibrillary acidic protein

    • GMR
      geometric mean ratio

    • HCP
      Health Care Provider

    • HGBCL
      High-grade B-cell lymphoma

    • HGBL
      high-grade B-cell lymphoma

    • HHV8
      human herpesvirus 8

    • HLA
      human leukocyte antigen

    • HLH
      Hemophagocytic lymphohistiocytosis

    • HR
      hazard ratio

    • ICANS
      Immune effector cell-associated neurotoxicity syndrome

    • ICU
      Intensive care unit

    • Ig
      Immunoglobulin

    • IgE
      Immunoglobulin E

    • IgG
      immunoglobulin G

    • IgG1
      Immunoglobulin G1

    • INR
      International normalized ratio

    • IPI
      International Prognostic Index

    • IR
      injection reaction

    • IRC
      Independent Review Committee

    • IRR
      Infusion-related reaction

    • ITIM
      Immunoreceptor tyrosine-based inhibitory motif

    • ITT
      intention-to-treat

    • IV
      intravenous

    • LLN
      Lower limit of normal

    • LLOQ
      lower limit of quantification

    • LMP
      last menstrual cycle

    • LMP
      Last menstrual period

    • MAS
      Macrophage activation syndrome

    • MBP
      myelin basic protein

    • MCA
      Major congenital anomalies

    • MedDRA
      Medical Dictionary for Regulatory Activities

    • MHC
      Major histocompatibility complex

    • min
      minutes

    • MRI
      magnetic resonance imaging

    • MS
      Multiple sclerosis

    • MSFC
      Multiple Sclerosis Functional Composite

    • MSKCC
      Memorial Sloan Kettering Cancer Center

    • MSSS
      Multiple Sclerosis Severity Scale

    • N/E
      new/enlarging

    • NfH
      neurofilament heavy chain

    • NfL
      neurofilament light chain

    • NK
      Natural killer

    • NO
      Nitric oxide

    • NOS
      Not otherwise specified

    • OB/Gyn
      Obstetrics and Gynecology

    • OCR
      ocrelizumab

    • OCR
      OCREVUS (ocrelizumab)

    • OCT
      optical coherence tomography

    • OR
      Odds ratio

    • ORR
      Objective response rate

    • OS
      overall survival

    • PD
      pharmacodynamic

    • PD-1
      Programmed cell death protein 1

    • PD-L1
      Programmed death-ligand 1

    • PET
      Positron emission tomography

    • PDR
      protocol-defined relapse

    • PFS
      Progression-free survival

    • PIRA
      progression independent of relapse activity

    • PK
      pharmacokinetics

    • PMBCL
      Primary mediastinal B-cell lymphoma

    • PML
      progressive multifocal leukoencephalopathy

    • Pola-R-CHP
      polatuzumab plus rituximab, cyclophosphamide, doxorubicin, prednisone

    • PPMS
      Primary progressive multiple sclerosis

    • PRLs
      paramagnetic rim lesions

    • PRO
      patient reported outcome

    • PTT
      Partial thromboplastin time

    • PVR
      Poliovirus receptor

    • R-CHOP
      rituximab plus cyclophosphamide, doxorubicin, vincristine, prednisone

    • R-CHP
      rituximab plus cyclophosphamide, doxorubicin, prednisone

    • RADIEMS
      Reserve Against Disability in Early MS

    • RAN
      rapid automatized naming

    • RAW
      relapse-associated worsening

    • rHuPH20
      recombinant human hyaluronidase PH20

    • RID
      Relative infant dose

    • RMS
      relapsing forms of multiple sclerosis

    • RMS
      Relapsing multiple sclerosis

    • RRMS
      Relapsing-remitting multiple sclerosis

    • SAE
      Serious adverse event

    • SC
      subcutaneous

    • SELs
      slowly expanding lesions

    • SPMS
      secondary progressive multiple sclerosis

    • T
      Trimester

    • T25FW
      Timed 25-Foot Walk

    • TCR
      T-cell receptor

    • TIGIT
      T cell immunoreceptor with Ig and ITIM domains

    • UCSF
      University of California San Francisco

    • USPI
      United States Prescribing Information

    • URTI
      Upper respiratory tract infection

    • UTI
      Urinary tract infection

    • VWF
      von Wilebrand factor

    • NIH
      National Institutes of Health

    • h
      hour