Durvalumab — Drug Monograph

Brand names: Imfinzi

Drug class: Checkpoint Inhibitor

Mechanism of Action

Human anti-PD-L1 IgG1κ monoclonal antibody with engineered Fc region to reduce ADCC/CDC. Blocks PD-L1 interaction with PD-1 and CD80. Clinical differentiation from atezolizumab is mainly in indications — the pivotal PACIFIC trial established durvalumab as the first immunotherapy for unresectable Stage III NSCLC following concurrent chemoradiation.

FDA Indications

• Unresectable Stage III NSCLC — consolidation therapy after platinum-based chemoradiation (PACIFIC trial)
• Extensive-stage SCLC — first-line with etoposide and carboplatin or cisplatin (CASPIAN trial)
• Biliary tract cancer — first-line with gemcitabine and cisplatin
• Hepatocellular carcinoma — first-line with tremelimumab (a CTLA-4 inhibitor)

Common Side Effects

• Cough
• Fatigue
• Rash
• Diarrhea
• Decreased appetite
• Hypothyroidism
• Radiation pneumonitis (higher frequency after chemoradiation)

Clinical Pearl

The PACIFIC trial (Stage III NSCLC consolidation) showed unprecedented results — 5-year OS of 42.9% with durvalumab vs. 33.4% with placebo, establishing durvalumab as standard of care for unresectable Stage III NSCLC. This benefit was consistent regardless of PD-L1 expression level. Pneumonitis monitoring is critical in this population due to prior lung radiation. Immune-related adverse event (irAE) management follows the standardized ASCO/NCCN/SITC grade-based ladder: Grade 1 — generally…

Related Therapies & Mechanisms

• Pembrolizumab (Keytruda) — Checkpoint Inhibitor · HCC
• Atezolizumab (Tecentriq) — Checkpoint Inhibitor · HCC
• Nivolumab (Opdivo) — Checkpoint Inhibitor · HCC
• Carboplatin (Paraplatin) — NSCLC