Bavencio

Merkel cell carcinoma (MCC) — metastatic, for adults and pediatric patients 12 years and older (including first-line); Locally advanced or metastatic urothelial carcinoma (UC) — maintenance treatment in patients whose disease has not progressed with first-line platinum-containing chemotherapy

800 mg IV every 2 weeks until disease progression or unacceptable toxicity
Infusion time: Over 60 minutes
Pre-medication: Acetaminophen and antihistamine prior to first 4 infusions; subsequently if prior infusion reaction occurred

Injection: 20 mg/mL in 10 mL (200 mg) single-dose vial

None listed.

• Immune-Mediated Adverse Reactions: Pneumonitis (1.2%), hepatitis (0.9%), colitis (1.5%), endocrinopathies (including thyroid disorders 6%, adrenal insufficiency 0.5%, type 1 DM 0.1%), nephritis (0.1%), dermatologic reactions.
• Infusion-Related Reactions: Reported in 25% (mostly Grade 1-2). Pre-medicate for first 4 infusions.
• Major Adverse Cardiovascular Events: In combination with axitinib, myocarditis was reported.
• Embryo-Fetal Toxicity

Fatigue (32%), musculoskeletal pain (17%), diarrhea (16%), nausea (14%), infusion-related reactions (25%), rash (15%), decreased appetite (13%), peripheral edema (13%), urinary tract infection (11%)

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

Consult the complete prescribing information for drug interactions, including effects on CYP enzymes, transporters, and concomitant medications that may require dose adjustments or monitoring.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Avelumab is a human IgG1λ monoclonal antibody that binds PD-L1 and blocks its interaction with PD-1 and B7.1 (CD80). This releases PD-L1-mediated suppression of anti-tumor T-cell responses. Unlike other anti-PD-L1 antibodies, avelumab has a wild-type IgG1 Fc region that retains the ability to engage innate immune effector cells and mediate antibody-dependent cell-mediated cytotoxicity (ADCC).

Half-life: 6.1 days. Clearance: 0.59 L/day. Vd: 4.7 L. Steady-state by ~4-6 weeks with q2w dosing. Linear PK across 1-20 mg/kg range.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• JAVELIN Bladder 100 — Avelumab maintenance vs. BSC after 1L platinum-based chemo in advanced urothelial carcinoma. Phase III, n=700.
  🔬 NCT02603432 ↗ 📄 Primary Publication ↗
• JAVELIN Merkel 200 — Avelumab in metastatic Merkel cell carcinoma after chemotherapy. Phase II, n=88.
  🔬 NCT02155647 ↗ 📄 Primary Publication ↗

Bavencio has FDA-approved indications across the following cancer types covered on PipelineEvidence: