Table 2.

Efficacy of osimertinib in the first-line treatment of EGFR mutation-positive advanced NSCLC in FLAURA

	Osimertiniba	Comparator EGFR-TKIsb
Full analysis set [10, 12]
No. of pts	279	277
Median PFSc (months)	18.9	10.2
Hazard ratio (95% CI)	0.46 (0.37–0.57)***
Median OSd (months)	38.6	31.8
Hazard ratio (95.05% CI)	0.80 (0.64–1.00)*
ORR (% of pts)	80	76
Odds ratio (95% CI)	1.27 (0.85–1.90)
CNS full analysis sete [13]
No. of pts	61	67
Median CNS PFSf (months)	NR	13.9
Hazard ratio (95% CI)	0.48 (0.26–0.86)**
CNS ORR (% of pts)	66	43
Odds ratio (95% CI)	2.5 (1.2–5.2)**

Data cut-off 12 June 2017 for all endpoints except OS (data cut-off 25 June 2019). PFS and ORR based on investigator assessment; CNS PFS and ORR based on neuroradiological BICR

BICR blinded independent central review, CNS central nervous system, EGFR epidermal growth factor receptor, NR not reached, ORR objective response rate, OS overall survival, PFS progression-free survival, pts patients, TKI tyrosine kinase inhibitor

*p = 0.046, **p ≤ 0.014, ***p < 0.001 vs comparator EGFR-TKIs

^a80 mg once daily

^bGefitinib 250 mg (n = 183 in full analysis set) or erlotinib 150 mg (n = 94) once daily

^cPFS was primary endpoint; time from randomization to objective disease progression or death (any cause)

^dAt the time of final OS analysis (alpha value 0.0495 to maintain overall 5% type 1 error rate across interim and final OS analyses)

^eAll pts with baseline CNS metastases (measurable or not) by BICR

^fTime from randomization to objective CNS progression or death (any cause)