Bavencio injection for metastatic Merkel cell carcinoma and advanced urothelial and renal cell carcinoma

Bavencio (avelumab) is a monoclonal antibody used as an intravenous injection to treat certain cancers by targeting the PD-L1 protein and enhancing the immune system's ability to attack cancer cells. It is approved for metastatic Merkel cell carcinoma, advanced or metastatic urothelial carcinoma, and, in combination with axitinib, for advanced renal cell carcinoma.

Bavencio is approved for use in:

• Adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC).
• Maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.
• Treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
• First-line treatment of patients with advanced renal cell carcinoma (RCC) when used in combination with axitinib.

avelumab

Bavencio is a programmed death ligand-1 (PD-L1) blocking antibody that binds PD-L1, inhibiting its interaction with PD-1 receptors on immune cells. This blockade prevents the cancer cells from evading immune detection, thereby enhancing the immune system's ability to recognize and attack tumor cells.

Administration: Bavencio is given as an intravenous infusion over 60 minutes every 2 weeks.

Dosage:

• Merkel Cell Carcinoma and Urothelial Carcinoma: 800 mg IV every 2 weeks until disease progression or unacceptable toxicity.
• Renal Cell Carcinoma (in combination with axitinib): 800 mg IV every 2 weeks plus axitinib 5 mg orally twice daily (12 hours apart), with or without food, until progression or unacceptable toxicity. Axitinib dose may be escalated every 2 weeks or longer as tolerated.

Premedication: Antihistamine and acetaminophen are recommended before the first 4 infusions; subsequent premedication is based on clinical judgment and prior infusion reactions.

Dose modifications: No dose reductions are recommended for Bavencio. Withhold for severe (Grade 3) immune-mediated adverse reactions; permanently discontinue for life-threatening (Grade 4) immune-mediated events, recurrent severe reactions requiring systemic immunosuppression, or inability to taper corticosteroids to ≤10 mg prednisone equivalent within 12 weeks. Specific dose withholding and discontinuation criteria vary by type and severity of adverse reaction as detailed in the label.

None specified.

Immune-mediated adverse reactions: Can affect any organ system and may be severe or fatal. Includes pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, and risk of organ transplant rejection. Close monitoring of liver enzymes, creatinine, and thyroid function is advised at baseline and periodically. Withhold or permanently discontinue based on severity.

Infusion-related reactions: Can occur; interrupt or slow infusion for Grade 1-2 reactions; permanently discontinue for Grade 3-4.

Allogeneic hematopoietic stem cell transplantation (HSCT): Fatal and serious complications have occurred when patients receive PD-1/PD-L1 inhibitors before or after allogeneic HSCT.

Cardiovascular: Major adverse cardiovascular events can occur when Bavencio is combined with axitinib; manage cardiovascular risk and discontinue treatment for Grade 3-4 events.

Embryo-fetal toxicity: Bavencio can cause fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for a defined period after last dose.

Immune-mediated side effects include pneumonitis, colitis, hepatitis, endocrine disorders, nephritis, dermatologic reactions, and myocarditis, which can be severe or fatal. Common infusion-related reactions may include fever, chills, flushing, and rash.

Bavencio is administered in combination with axitinib for renal cell carcinoma. When administered together, monitor liver enzymes closely. Withhold both agents with significant liver enzyme elevation and consider corticosteroids. Dose reductions of axitinib may be necessary upon rechallenge.

Pregnancy: Bavencio can cause fetal harm. Women of reproductive potential should use effective contraception during treatment and for a recommended time after the last dose.

Lactation: No specific lactation information provided.

Store vials protected from light. Diluted Bavencio solution should be stored at room temperature (up to 25°C/77°F) for no more than 4 hours or under refrigeration (2°C to 8°C/36°F to 46°F) for no more than 24 hours prior to administration. Do not freeze or shake the solution.