Immune checkpoint inhibitors monotherapy for EGFR-mutated NSCLC

TreatmentStudy nameSettingDrugsPhaseEfficacyAEsReference
IO monotherapyKEYNOTE-001PretreatedPembrolizumabIORR 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]
NCT028799941stPembrolizumabIIORR 0%.TRAE: 46%, no grade 4–5 (38%). 6/7 patients had a TRAE on second-line EGFR-TKI.[35]
Checkmate0122ndNivolumabIORR: 14% vs. 30%; mPFS: 1.8 months vs. 8.8 months.Grade 3–4 in 14 (37%), no G5, in the ITT population.[36]
WJOG8515L2ndNivolumab vs. Cb + pemetrexedIINivolumab/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]
BIRCH1st to 3rdAtezolizumabIIORRs 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]
ATRANTICLess than 3rdDurvalumabIIORR was 12%.Treatment-related serious adverse events occurred in 5%.[41]
Dual-IONCT030914912ndNivolumab vs. nivolumab + ipillimumabIORR 3.2%, PFS 1.22 months in overall cohort.2/31 of grade 3 TRAE in the overall cohort[43]
KEYNOTE 021Less than 2ndPembrolizumab plus ipilimumabI/IIOne 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

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