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Table 1 Efficacy of durvalumab in combination with etoposide plus either cisplatin or carboplatin in treatment-naïve patients with extensive-stage small cell lung cancer in the CASPIAN trial

From: Durvalumab: A Review in Extensive-Stage SCLC

Treatment OSa (months) PFSb (months) ORRc (% of pts)
Planned interim analysis (data cut-off 11 March 2019) [11]
 DUR+EP (n = 268) 13.0d 5.1d 79
 EP (n = 269) 10.3d 5.4d 70
 HR/OR (95% CI) HR 0.73 (0.59–0.91)e* HR 0.78 (0.65–0.94)f OR 1.64 (1.11–2.44)
Updated analysis (data cut-off 27 January 2020) [12]
 DUR+EP (n = 268) 12.9d 5.1d 79
 EP (n = 269) 10.5d 5.4d 71
 HR/OR (95% CI) HR 0.75 (0.62–0.91)** HR 0.80 (0.66–0.96)f OR 1.61 (1.09‒2.40)
  1. DUR durvalumab, EP platinum (investigator’s choice of either carboplatin or cisplatin) plus etoposide, HR hazard ratio, OR odds ratio, ORR objective response rate, OS overall survival, PFS progression-free survival
  2. *p = 0.0047, **p = 0.0032 (nominal) vs. EP
  3. aPrimary endpoint; defined as time from randomization to death from any cause
  4. bSecondary endpoint; defined as time from randomization to the date of objective disease progression or death from any cause in the absence of progression
  5. cUnconfirmed ORR (secondary endpoint); defined as proportion of patients with a complete response or partial response on ≥ 1 visit
  6. dMedian value
  7. eMet the boundary for declaring statistical significance (i.e. p < 0.0178)
  8. fPFS could not be tested for significance within the multiple-testing procedure due to the hierarchical study design