Advanced NSCLC: FDA approves atezolizumab plus chemotherapy


  • Kelli Whitlock Burton
  • Oncology drug update
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Takeaway

  • The US FDA has approved atezolizumab in combination with paclitaxel protein-bound and carboplatin for first-line treatment of adults with metastatic NSCLC with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations.

Why this matters

  • Atezolizumab was first approved in 2016 in NSCLC patients with disease progression after treatment with platinum-based chemotherapy, and then in 2018 for first-line treatment in advanced NSCLC in combination with bevacizumab, paclitaxel, and carboplatin.
  • EMA information on atezolizumab indications, including NSCLC, is available here.

Key points

  • Recommended dosage 1200 mg/20 mL (60 mg/mL) by intravenous infusion every 3 weeks.
  • Approval based on study results of the multicenter, randomized, open-label, phase 3 IMpower130 trial.
    • 681 patients receive atezolizumab, paclitaxel protein-bound, and carboplatin, followed by single-agent atezolizumab or paclitaxel protein-bound and carboplatin, followed by maintenance pemetrexed (control).
    • Median PFS was 7.2 months with atezolizumab vs 6.5 months in the control group (HR, 0.75; P=.0024).
    • Median OS was 18.6 months with atezolizumab vs 13.9 months in the control group (HR, 0.80; P=.0384).
  • Most common adverse events when administered in combination with other antineoplastic drugs in patients with NSCLC and small-cell lung cancer were fatigue/asthenia, nausea, alopecia, constipation, diarrhea, and decreased appetite.

For prescribing information, click here.