AstraZeneca's Imfinzi Recommended for Approval in EU for Extensive-Stage Small Cell Lung Cancer Treatment

Strategic Insights -

AstraZeneca's Imfinzi (durvalumab) has been recommended for marketing authorisation in the European Union (EU) for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the Phase III CASPIAN trial, which showed that Imfinzi plus chemotherapy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit for the 1st-line treatment of patients with ES-SCLC, reducing the risk of death by 27% versus chemotherapy alone.

Key Takeaways:

  • Imfinzi has been recommended for approval in the EU for the 1st-line treatment of adults with ES-SCLC in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin.
  • The Phase III CASPIAN trial demonstrated a statistically significant and clinically meaningful OS benefit for Imfinzi plus chemotherapy, reducing the risk of death by 27% versus chemotherapy alone.
  • The trial also showed an increased confirmed objective response rate in the Imfinzi plus chemotherapy arm (68% versus 58% for chemotherapy alone) and that Imfinzi added to chemotherapy delayed the time it took for lung cancer-related symptoms to worsen.
  • No patients tested positive for treatment-emergent anti-drug antibodies to Imfinzi, indicating a well-tolerated treatment.
  • The CHMP recommendation is for Imfinzi in combination with etoposide and either carboplatin or cisplatin for the 1st-line treatment of adults with ES-SCLC.
  • Imfinzi is also approved in the US and several other countries around the world for the treatment of ES-SCLC in the 1st-line setting and is currently under regulatory review in Japan and other countries.
  • Small cell lung cancer is a highly aggressive, fast-growing form of lung cancer that typically recurs and progresses rapidly despite initial response to chemotherapy, with a poor prognosis and limited treatment options.
  • The CASPIAN trial was a randomised, open-label, multi-centre, global, Phase III trial in the 1st-line treatment of 805 patients with ES-SCLC, comparing Imfinzi in combination with etoposide and either carboplatin or cisplatin chemotherapy or Imfinzi and chemotherapy with the addition of a second immunotherapy, tremelimumab, versus chemotherapy alone.

Statistics:

  • 27% reduction in risk of death for Imfinzi plus chemotherapy versus chemotherapy alone (based on a hazard ratio [HR] of 0.73; 95% confidence interval [CI] 0.59-0.91; p=0.0047).
  • 68% confirmed objective response rate in the Imfinzi plus chemotherapy arm versus 58% for chemotherapy alone.
  • No patients tested positive for treatment-emergent anti-drug antibodies to Imfinzi.

Sources:

  • M2 Communications
  • AstraZeneca
  • The Lancet
  • European Medicines Agency
  • CASPIAN trial
  • National Cancer Institute
  • Kalemkerian GP, et al. Treatment Options for Relapsed Small-Cell Lung Cancer: What Progress Have We Made? Journal of Oncology Practice, 2018:14;369-370.
  • Paz-Ares L, et al. Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial. The Lancet. 2019;394(10212):1929-1939.