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] |
| 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