FDA approves add-on durvalumab for small cell lung cancer

  • FDA
  • 30 Mar 2020

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • The FDA approved durvalumab in combination with etoposide+ carboplatin/cisplatin in treatment-naive patients with extensive-stage small cell lung cancer (ES-SCLC).
  • The recommended dose is 1500 mg every 3 weeks before chemotherapy, and then every 4 weeks as a single agent.

Why this matters

  • The combination is the new standard of care in this setting.

Key highlights

  • Approval was based on the randomized, multicenter, active-controlled, open-label CASPIAN trial.
  • 537 patients with ES-SCLC randomly assigned to durvalumab plus chemotherapy (n=268) vs chemotherapy alone (n=269).
  • Adding durvalumab significantly improved median OS (13.0 vs 10.3 months; HR, 0.73; P=.0047) vs chemotherapy alone.
    • Investigator-assessed PFS: HR, 0.78 (95% CI, 0.65-0.94).
    • Median PFS: 5.1 (95% CI, 4.7-6.2) months with durvalumab+chemotherapy and 5.4 (95% CI, 4.8-6.2) months with chemotherapy alone.
  • Confirmed objective response rate (investigator assessed) was 68% in the durvalumab+chemotherapy group vs 58% with chemotherapy alone.
  • The most common adverse events (AEs; ≥20%) were nausea, fatigue/asthenia, and alopecia.
  • The serious AE rate in the durvalumab+chemotherapy group was comparable with that for chemotherapy alone (30.9% vs 36.1%).
  • Immune-mediated AEs were higher with durvalumab+chemotherapy (19.6% vs 2.6%).

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