Qibeian Iparomlimab and Tuvonralimab Injection

1. Indications and Usage
Cervical Cancer: Indicated for the treatment of adult patients with recurrent or metastatic cervical cancer who have progressed on or after standard therapy.
Non-Small Cell Lung Cancer: Indicated for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) who have progressed on or after platinum-based chemotherapy.
Other Solid Tumors: Investigated in clinical trials for other solid tumors including hepatocellular carcinoma, biliary tract malignancies, and triple-negative breast cancer.
2. Dosage and Administration
Recommended Dose: The recommended dose is 5 mg/kg administered intravenously once every 3 weeks.
Administration: Infusion should be administered over 90 minutes. If tolerated, subsequent infusions may be shortened.
Premedication: Premedication with antihistamines or corticosteroids is not routinely required but may be considered if a prior infusion-related reaction occurs.
Duration: Continue treatment until disease progression or unacceptable toxicity.
3. Mechanism of Action
Dual Checkpoint Inhibition: Iparomlimab and Tuvonralimab is a bispecific antibody composed of iparomlimab (PD-1 inhibitor) and tuvonralimab (CTLA-4 inhibitor).
T-Cell Activation: By simultaneously blocking PD-1 and CTLA-4, it enhances T-cell activation, proliferation, and infiltration into the tumor microenvironment, thereby promoting anti-tumor immune responses.
4. Safety and Warnings
Immune-Mediated Adverse Reactions: Serious or fatal immune-mediated reactions may occur involving any organ system. Common severe events include colitis, hepatitis, pneumonitis, dermatitis, and endocrinopathies.
Infusion-Related Reactions: Moderate to severe infusion-related reactions may occur and require immediate infusion interruption and supportive care.
Fetal Toxicity: Based on its mechanism, it can cause fetal harm.
5. Adverse Reactions and Clinical Research
Adverse Reactions: In clinical trials, the most common adverse reactions (incidence ≥10%) included hypothyroidism, hyperthyroidism, anemia, leukopenia, rash, increased ALT, increased AST, neutropenia, fatigue, and lymphopenia.
Clinical Research: Clinical trials demonstrated efficacy in multiple tumor types, with immune-related adverse events being the primary safety concern requiring vigilant monitoring.
6. Drug Interactions
Immunosuppressants: Systemic corticosteroids or other immunosuppressants used for managing immune-related adverse reactions may reduce the efficacy of the drug.
Live Vaccines: Use of live vaccines should be avoided during treatment.
7. Pharmaceutical Information
Composition: The active ingredients are iparomlimab and tuvonralimab, forming a bispecific antibody complex.
Appearance: The solution is clear to slightly opalescent and colorless to pale yellow.
Storage: Store in a refrigerator at 2°C to 8°C. Do not freeze. Protect from light.