Table Info

Table 1.

Immune checkpoint inhibitors monotherapy for EGFR-mutated NSCLC

Treatment	Study name	Setting	Drugs	Phase	Efficacy	AEs	Reference
IO monotherapy	KEYNOTE-001	Pretreated	Pembrolizumab	I	ORR 50%, mPFS of 157.5 days in four EGFR-TKI-naive patients; ORR 4%, mPFS 56 days in EGFR-TKI treated patients.	No report for EGFR patients.	[34]
	NCT02879994	1st	Pembrolizumab	II	ORR 0%.	TRAE: 46%, no grade 4–5 (38%). 6/7 patients had a TRAE on second-line EGFR-TKI.	[35]
	Checkmate012	2nd	Nivolumab	I	ORR: 14% vs. 30%; mPFS: 1.8 months vs. 8.8 months.	Grade 3–4 in 14 (37%), no G5, in the ITT population.	[36]
	WJOG8515L	2nd	Nivolumab vs. Cb + pemetrexed	II	Nivolumab/Cb + pemetrexed, ORR 9.6% vs. 36.0%, mPFS 1.7 months vs. 5.6 months.	Serious AEs: 25.5% in nivolumab and 16.0% in chemotherapy.	[39]
	BIRCH	1st to 3rd	Atezolizumab	II	ORRs for mutant/wild-type in cohorts 1, 2, and 3 were 23%/19%, 0%/21%, and 7%/18%, respectively.	Grade 3 to 4 AEs occurred in 42% of patients (12% treatment-related).	[40]
	ATRANTIC	Less than 3rd	Durvalumab	II	ORR was 12%.	Treatment-related serious adverse events occurred in 5%.	[41]
Dual-IO	NCT03091491	2nd	Nivolumab vs. nivolumab + ipillimumab	I	ORR 3.2%, PFS 1.22 months in overall cohort.	2/31 of grade 3 TRAE in the overall cohort	[43]
Dual-IO	KEYNOTE 021	Less than 2nd	Pembrolizumab plus ipilimumab	I/II	One of the 12 patients showed an objective response.	-	[44]

IO: immune-oncology; ORR: objective response rate; EGFR: epidermal growth factor receptor; TKIs: tyrosine kinase inhibitors; TRAE: treatment related adverse event; mPFS: median progression free survival; ITT: intent-to-treat; AEs: adverse events; ALK: anaplastic lymphoma kinase. -: no data

Declarations

Author contributions

KA, TS, AI, TH, YG, NH, and MK: Writing—review & editing. KI: Writing—review & editing, Supervision. YO: Conceptualization, Data curation, Writing—review & editing. All authors read and approved the submitted version.

Conflicts of interest

YO reports personal fees from Bristol Myers Squibb, Eli Lilly, Takeda, Daiichi Sankyo, AstraZeneca, Chugai Pharma, Amgen, and Novartis, and personal fees from Taiho outside the submitted work. YG reports personal fees from Bristol Myers Squibb, Eli Lilly, Takeda, AstraZeneca, Chugai Pharma, Taiho, and Boehringer Ingelheim outside the submitted work. NH received a research grant from Boehringer Ingelheim and lecture fees from GlaxoSmithKline, AstraZeneca, Novartis, and Boehringer Ingelheim, outside the submitted work. MK received personal fees from Bristol Myers Squibb, Eli Lilly, Takeda, Daiichi Sankyo, AstraZeneca, Chugai Pharma, MSD, and Taiho outside the submitted work. KI reports personal fees from GSK, MSD, Sanofi, AstraZeneca, and Chugai Pharmaceutical Co., and he received research grants from Chugai Pharmaceutical Co. and Taiho Pharmaceutical Co. The other authors declare that they have no conflict of interest.

Ethical approval

Not applicable.

Consent to participate

Not applicable.

Consent to publication

Not applicable.

Availability of data and materials

Not applicable.

Funding

Not applicable.

Copyright

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