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

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)

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

*p = 0.0047, **p = 0.0032 (nominal) vs. EP

^aPrimary endpoint; defined as time from randomization to death from any cause

^bSecondary endpoint; defined as time from randomization to the date of objective disease progression or death from any cause in the absence of progression

^cUnconfirmed ORR (secondary endpoint); defined as proportion of patients with a complete response or partial response on ≥ 1 visit

^dMedian value

^eMet the boundary for declaring statistical significance (i.e. p < 0.0178)

^fPFS could not be tested for significance within the multiple-testing procedure due to the hierarchical study design