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Durvalumab

Brand and Other Names: IMFINZI
Mechanism of Action:

Expression of programmed cell death ligand-1 (PD-L1) can be induced by inflammatory signals (e.g., IFN-gamma) and can be expressed on both tumor cells and tumor-associated immune cells in the tumor microenvironment. PD-L1 blocks T-cell function and activation through interaction with PD-1 and CD80 (B7.1). By binding to its receptors, PD-L1 reduces cytotoxic T-cell activity, proliferation, and cytokine production.

Durvalumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80 (B7.1). Blockade of PD-L1/PD-1 and PD-L1/CD80 interactions releases the inhibition of immune responses, without inducing antibody dependent cell-mediated cytotoxicity (ADCC).

PD-L1 blockade with durvalumab led to increased T-cell activation in vitro and decreased tumor size in co-engrafted human tumor and immune cell xenograft mouse models.

Indications:

Non-Small Cell Lung Cancer (NSCLC)

  • Resectable NSCLC: Neoadjuvant use with platinum-based chemotherapy, followed by adjuvant monotherapy.

  • Unresectable Stage III NSCLC: As a monotherapy post concurrent chemoradiation.

  • Metastatic NSCLC: In combination with tremelimumab-actl and platinum-based chemotherapy (no EGFR or ALK mutations).

Small Cell Lung Cancer (SCLC)

  • Limited-stage: As monotherapy post concurrent chemoradiation.

  • Extensive-stage: In combination with etoposide and either cisplatin or carboplatin.

Other Indications

  • Biliary Tract Cancer (BTC): With gemcitabine and cisplatin.

  • Unresectable Hepatocellular Carcinoma (uHCC): With tremelimumab-actl.

  • Mismatch Repair Deficient (dMMR) Endometrial Cancer: With carboplatin and paclitaxel, followed by monotherapy.

  • Muscle Invasive Bladder Cancer (MIBC): Neoadjuvant with gemcitabine/cisplatin, followed by adjuvant monotherapy.

Route: intravenous
Dose:

Formulation: Injection available in 500 mg/10 mL and 120 mg/2.4 mL vials.

Administration: Intravenous infusion over 60 minutes.

Dosing depends on weight and indication (e.g., fixed 1,500 mg doses for ≥30 kg patients; weight-based mg/kg for <30 kg).

Adverse Reactions:

Common Adverse Reactions (≥20%) (vary by indication):

  • NSCLC: Anemia, nausea, fatigue, pneumonitis, rash, URT infections.

  • SCLC: Fatigue, pneumonitis, nausea, alopecia.

  • BTC: Fatigue, abdominal pain, constipation, rash, pyrexia.

  • Endometrial Cancer: Peripheral neuropathy, diarrhea, rash, musculoskeletal pain.

  • MIBC: Nausea, decreased blood counts, increased creatinine, rash, diarrhea.

 

Contraindication:

None

Warnings and Precautions:

IMFINZI can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation.

See package insert for full prescribing information.