Table 3.

Summary of Phase II/III studies of dacomitinib

Study	Phase	Treatment	Patient population	Sample size	ORR	PFS	OS
ARCHER 100221	II	Dacomitinib 45 mg daily	Failed erlotinib and at one or two chemotherapy regimens; KRAS WT or EGFR exon 19 deletion/L858R	66 (ADC 50, non-ADC 16)	ADC: 4.8% Non-ADC: 6.3% EGFR-mutant: 8%	ADC: 12 weeks Non-ADC: 11 weeks EGFR-mutant: 18 weeks	ADC: 45 weeks Non-ADC: 27 weeks EGFR-mutant: 57 weeks
ARCHER 101724	II	Dacomitinib 45 mg daily	Never/light smokers, ADC, KRAS WT if non-Asian, or EGFR-mutant	89	EGFR-mutant: 75.6%	11.5 months Common EGFR-mutant: 18.2 months (95% CI 12.8–23.8)	EGFR-mutant: 40.2 months (95% CI 29.0 months to NR)
ARCHER 102826	II	Dacomitinib 45 mg daily versus erlotinib 150 mg daily	One or two prior chemotherapies	188	17% versus 5.3%	2.86 months (95% CI 1.87–3.71) versus 1.91 months (95% CI 1.82–2.69) HR 0.66 (95% CI 0.47–0.91, P=0.012)	9.53 versus 7.44 months (HR 0.80, 95% CI 0.56–1.13; P=0.205)
ARCHER 100927	III	Dacomitinib 45 mg daily versus erlotinib 150 mg daily	One or two prior chemotherapies	878	Overall population: 11.4% versus 8.2% (P=0.083) KRAS WT patients: 13.3% versus 11.0% (P=0.261) KRAS WT/EGFR WT: 1.9 versus 1.9 months (HR 1.01, 95% CI 0.81–1.25; P=0.075)	Overall population: 2.6 versus 2.6 months (HR 0.94, 95% CI 0.80–1.10; one-sided P=0.229) KRAS WT patients: HR 1.02 (95% CI 0.83–1.25, one-sided P=0.587)	Overall population: 7.9 versus 8.4 months (HR 1.08, 95% CI 0.91–1.27; P=0.82) KRAS WT patients: 8.1 versus 8.5 months (HR 1.10, 95% CI 0.88–1.36; P=0.80)

Abbreviations: CI, confidence interval; HR, hazard ratio; NR, not reached; ORR, overall response rate; PFS, progression-free survival; OS, overall survival; WT, wild type; ADC, adenocarcinoma.