Active Ingredient: Sugemalimab
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:
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.
The use of systemic corticosteroids or immunosuppressants before starting sugemalimab should be avoided.
When sugemalimab is administered in combination with chemotherapy, refer to the Summary of Product Characteristics (SmPC) of the combination products.
Table 1. Recommended dose for sugemalimab by intravenous administration:
| Indication | Recommended dose and schedule | Duration of Treatment |
|---|---|---|
| Sugemalimab combination therapy | ||
| First line squamous metastatic NSCLC | During platinum-based chemotherapy: • 1200 mg (for individuals weighing 115 kg or less) followed by intravenous infusion of carboplatin and paclitaxel on day 1 for up to 4 cycles every 3 weeks; • 1500 mg (for individuals weighing more than 115 kg) followed by intravenous infusion of carboplatin and paclitaxel on day 1 for up to 4 cycles every 3 weeks. Post-platinum-based chemotherapy: • 1200 mg (for individuals weighing 115 kg or less) every 3 weeks for the duration of the therapy; • 1500 mg (for individuals weighing more than 115 kg) every 3 weeks for the duration of the therapy. | Treatment should be continued until disease progression, or unacceptable toxicity. |
| First line non- squamous metastatic NSCLC | During platinum-based chemotherapy: • 1200 mg (for individuals weighing 115 kg or less) followed by intravenous infusion of carboplatin and pemetrexed on day 1 for up to 4 cycles every 3 weeks; • 1500 mg (for individuals weighing more than 115 kg) followed by intravenous infusion of carboplatin and pemetrexed on day 1 for up to 4 cycles every 3 weeks. Post-platinum-based chemotherapy: • 1200 mg (for individuals weighing 115 kg or less) and pemetrexed are administered every 3 weeks for the duration of the therapy; • 1500 mg (for individuals weighing more than 115 kg) and pemetrexed are administered every 3 weeks for the duration of the therapy. | Treatment should be continued until disease progression, or unacceptable toxicity. |
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 2.
Table 2. 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 pancreatitis | Grade 2 pancreatitis† | Withhold until the adverse reaction recovers to Grade 0 to 1. |
| Grade 3 or 4 pancreatitis | Permanently discontinue. | |
| Immune-related ocular toxicities | Grade 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 immune-related 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. | |
| Non-immune-mediated adverse reactions | Grade 2 and 3 | Withhold until non-immune- mediated adverse reactions recovers to Grade 0 to 1. |
| Grade 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.
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.
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