Non-small-cell lung cancer

Active Ingredient: Sugemalimab

Indication for Sugemalimab

Population group: only adults (18 years old or older)
Therapeutic intent: Curative procedure

Sugemalimab in combination with platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small-cell lung cancer (NSCLC) with no sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations.

For this indication, competent medicine agencies globally authorize below treatments:

For patients weighing ≤115 kg 1,200 mg and for patients weighing >115 kg 1,500 mg once every 3 weeks

For:

Dosage regimens

Regimen A: In case that patient weight is ≤ 115 kg, intravenous, 1,200 milligrams sugemalimab, once every 3 weeks.

Regimen B: In case that patient weight is ≥ 115 kg, intravenous, 1,500 milligrams sugemalimab, once every 3 weeks.

Detailed description

The use of systemic corticosteroids or immunosuppressants before starting sugemalimab should be avoided.

Recommended dose

For squamous cell carcinoma

Sugemalimab 1200 mg (for individuals weighing 115 kg or less) or 1500 mg (for individuals weighing more than 115 kg) is infused intravenously over 60 minutes followed by intravenous infusion of carboplatin and paclitaxel on day 1 for up to 4 cycles every 3 weeks. Thereafter, sugemalimab 1200 mg (for individuals weighing 115 kg or less) or 1500 mg (for individuals weighing more than 115 kg) is administered every 3 weeks for the duration of therapy.

For non-squamous cell carcinoma

Sugemalimab 1200 mg (for individuals weighing 115 kg or less) or 1500 mg (for individuals weighing more than 115 kg) is infused intravenously over 60 minutes followed by intravenous infusion of carboplatin and pemetrexed on day 1 for up to 4 cycles every 3 weeks. Thereafter, sugemalimab 1200 mg (for individuals weighing 115 kg or less) or 1500 mg (for individuals weighing more than 115 kg) and pemetrexed are administered every 3 weeks for the duration of therapy.

Sugemalimab is administered in combination with chemotherapy. Refer to the full prescribing information for the combination products.

Duration of treatment

Treatment should be continued until disease progression, or unacceptable toxicity.

Treatment modification

The dose of sugemalimab should not be increased or reduced. Treatment withholding or discontinuation may be required based on individual safety and tolerability. Recommended treatment modifications are provided in Table 1.

Table 1. Recommended treatment modifications of sugemalimab:

Adverse reaction Severity* Treatment modification
Immune-related pneumonitis Grade 2 Withhold until the adverse
reaction recovers to Grade 0
to 1.
Grade 3 or 4, or recurrent Grade 2 Permanently discontinue.
Immune-related colitis Grade 2 or 3 Withhold until the adverse
reaction recovers to Grade 0
to 1.
Grade 4 or recurrent Grade 3 Permanently discontinue.
Immune-related nephritis Grade 2 blood creatinine increased Withhold until the adverse
reaction recovers to Grade 0
to 1.
Grade 3 or 4 blood creatinine
increased
Permanently discontinue.
Immune-related pancreatitisGrade 2 pancreatitis Withhold until the adverse
reaction recovers to Grade 0
to 1.
Grade 3 or 4 pancreatitis Permanently discontinue.
Immune-related ocular toxicitiesGrade 2 ocular toxicities Withhold until the adverse
reaction recovers to Grade 0
to 1.
Grade 3 or 4 ocular toxicities Permanently discontinue.
Immune-related endocrine
disorders
Symptomatic Grade 2 or 3
hypothyroidism
Grade 2 or 3 hyperthyroidism
Grade 2 or 3 symptomatic
hypophysitis
Grade 2 adrenal insufficiency
Type-1 diabetes mellitus associated
Grade 3 hyperglycaemia
Withhold until the adverse
reaction recovers to Grade 0
to 1.
Grade 4 hypothyroidism
Grade 4 hyperthyroidism
Grade 4 symptomatic hypophysitis
Grade 3 or 4 adrenal insufficiency
Type-1 diabetes mellitus associated
Grade 4 hyperglycaemia
Permanently discontinue.
Immune-related hepatitis Grade 2, aspartate
aminotransferase (AST) or alanine
aminotransferase (ALT) at > 3 to
5 times the upper limit of
normal (ULN) or total bilirubin (TBIL)
at > 1.5 to 3 times the ULN
Withhold until the adverse
reaction recovers to Grade 0
to 1.
Grade 3 or 4, AST or ALT > 5 times
the ULN, or TBIL > 3 times the ULN
Permanently discontinue.
Immune-related skin reactions Grade 3
Suspected Stevens-Johnson
syndrome (SJS) or toxic epidermal
necrolysis (TEN)
Withhold until the adverse
reaction recovers to Grade 0
to 1.
Grade 4
Confirmed SJS or TEN
Permanently discontinue.
Other immune-related adverse
reactions
First occurrence of other Grade 2 or
Grade 3 immune-related adverse
reactions depending on the reaction
severity and type
Withhold until the adverse
reaction recovers to Grade 0
to 1.
Grade 2, 3 or 4 myocarditis
Grade 3 or 4 encephalitis
Grade 4 myositis
First occurrence of other Grade 4
immune-related adverse reactions
Permanently discontinue.
Recurrent adverse reactions Recurrent Grade 3 or 4 (except for
endocrine disorders)
Permanently discontinue.
Infusion-related reactions Grade 2 Infusion should be
interrupted and may be
resumed at 50% of previous
rate once infusion related
reactions have resolved or
decreased to Grade ≤1, with
close observation ensured.
Grade 3 or 4 Permanently discontinue.

* Toxicity Grades are in accordance with the National Cancer Institute’s Common Terminology Criteria for Adverse Events, Version 4.03 (NCI CTCAE V4.03).
Continued clinical monitoring is recommended for asymptomatic pancreatitis or increase in pancreatic enzyme/lipase, but no temporary medicinal products discontinuation is required.

Dosage considerations

Sugemalimab after dilution is administered as an intravenous infusion over 60 minutes.

Sugemalimab must not be administered as an intravenous push or bolus injection.

The diluted sugemalimab solution is administered first, followed by chemotherapy. Chemotherapy may be started 30 minutes after completion of sugemalimab administration.

Active ingredient

Sugemalimab

Sugemalimab is a fully human immunoglobulin G4 monoclonal antibody. It specifically binds to programmed cell death ligand 1 (PD-L1), thus blocking its ligation with PD-1.

Read more about Sugemalimab

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