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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
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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:

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  • AAAAI
    American Academy of Allergy Asthma & Immunology

  • AE
    Adverse event

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    Angiopoietin-2

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    Annualized Relapse Rate

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    Assisted Reproductive Technology

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    American Society for Transplantation and Cellular Therapy

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    Anti-thymocyte globulin

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    Disease-modifying therapy

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    Follicular lymphoma

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    High-grade B-cell lymphoma

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    Hemophagocytic lymphohistiocytosis

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