. Author manuscript; available in PMC: 2020 Apr 23.

Published in final edited form as: J Thorac Oncol. 2016 Mar 2;11(7):976–988. doi: 10.1016/j.jtho.2016.02.015

Table 3.

Association between EGFR Mutation/KRAS Mutation/ALK Fusion Gene and Efficacy of Anti-PD-1/PD-L1 Antibody

Study Name (Phase)	Histologic Diagnosis	Line	Agent/Dose	N	Genetic Alteration and No. Patients		OS in overall patients (mo)	Genetic Alteration and OS		PFS in overall patients (mo)	Genetic Alteration and PFS		RR in overall patients (%)	Genetic Alteration and RR
CheckMate003⁴⁴ (phase 1)	NSCLC	Second +	Nivolumab 1 mg/kg every 2 wk 3 mg/kg every 2 wk 10 mg/kg every 2 wk	129	EGFR mutant	12							17%	EGFR mutant	16.7%
					EGFR wild	56								EGFR wild	19.6%
					KRAS mutant	21								KRAS mutant	14.3%
					KRAS wild	36								KRAS wild	25.0%
CheckMate057⁹ (phase 3)	Non-SqNSCLC	Second	Nivolumab 3 mg/kg every 2 wk (vs. docetaxel)	292 (290)	EGFR mutant	82	12.2 (0.73^a)	EGFR mutant	1.18^a	2.3 (0.92^a)	EGFR mutant	1.46^a
					EGFR wild	340		EGFR wild	0.66^a		EGFR wild	0.83^a
					KRAS mutant	62		KRAS mutant	0.52^a		KRAS mutant	0.82^a
					KRAS wild	123		KRAS wild	0.98^a		KRAS wild	1.52^a
					ALK positive	0		ALK positive	–		ALK positive	–
					ALK negative	243		ALK negative	0.71^a		ALK negative	0.81^a
KEYNOTE010¹⁸ (phase 3)	PD-L1 + NSCLC	Second +	Pembrolizumab 2 mg/kg every 3 wk 10 mg/kg every 3 wk (vs. docetaxel)	690 (343)	EGFR mutant	86	0.67^a	EGFR mutant	0.88^a
KEYNOTE010¹⁸ (phase 3)	PD-L1 + NSCLC	Second +			EGFR wild	875		EGFR wild	0.66^a
Phase 3/4 study of nivolumab⁴⁵	NSCLC	Second +	Nivolumab 3 mg/kg every 2 wk	531	EGFR mutant	55							12%	EGFR mutant	16%
					EGFR wild	300								EGFR wild	11%
					ALK positive	12								ALK positive	8%
					ALK négative	299								ALK negative	12%

Indicating hazard ratio compared with in the control arm.

EGFR, epidermal growth factor receptor gene; KRAS, Kirsten rat sarcoma viral oncogene homolog gene; ALK, anaplastic lymphoma kinase gene; PD-1, programmed death protein 1; PD-L1, programmed death ligand 1; OS, overall survival; PFS, progression-free survival; RR, response rate; NSCLC, non-small cell lung cancer; Non-SqNSCLC, nonsquamous cell non-small cell lung cancer.