Table 1.
Summary of results from included clinical trials of epidermal growth receptor tyrosine kinase inhibitors in combination with immune checkpoint inhibitors.
| Clinical Trial | Author | Phase | Key Eligibility Criteria | Treatment Arms | Primary Objective | Treatment Line | Median Age (Range), Years) | Sample Size (Female%) |
Grade 3/4 trAE | Discontinuation Due to Adverse Events | ORR | PFS (Months) | DOR (Months) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TATTON/NCT02143466 | Oxnard et al. | Ib | Advanced EGFR-mutant NSCLC and disease progression to a prior TKI | Arm 1: osimertinib 80 mg daily + durvalumab 3 mg/kg every 2 weeks (n = 10) Arm 2: osimertinib 80 mg daily + durvalumab 10 mg/kg every 2 weeks (dose escalation) | Safety, tolerability | ≥s | Arm 1: 67 (46–78) Arm 2: 58 (44–73) |
Arm 1: 10 (70%) Arm 2: 13 (54%) |
Arm 1: 60%, Arm 2: 38.5% |
Arm 1: 30% a, 40% b Arm 2: 23.1% a, 38.5% b |
Arm 1: 40%, Arm 2: 39% |
NA | NA |
| CheckMate012/NCT01454102 | Gettinger et al. | I | EGFR-mutant chemotherapy-naïve, EGFR-TKI naïve or TKI treated stage IIIB/IV NSCLC | Nivolumab 3 mg/kg every 2 weeks and erlotinib 150 mg/d | Safety, tolerability | ≥s | 63 (41–80) |
21 (62%) | 24% | 10% | 15% | 48 | 5.1 c, 5.7 d |
| CAURAL/NCT02454933 | Yang et al. | III | EGFR T790M-positive, TKI-treated NSCLC | Arm 1: Osimertinib (80 mg once daily) Arm 2: osimertinib (80 mg once daily) + durvalumab (10 mg/kg IV every 2 weeks) |
Safety, tolerability | ≥s | Arm 1: 65 (41–80) Arm2: 56 (41–78) |
Arm 1: 17 (76%) Arm 2: 12 (50%) |
34% | 17% | 80% a, 64% e | NA | NA |
DOR, duration of response; EGFR, epidermal growth factor receptor; NA, not available; NSCLC, non-small cell lung cancer; PFS, progression-free survival; ORR, objective response rate; trAE, treatment-related adverse events; TKI, tyrosine kinase inhibitor. a Attributed to osimertinib. b Attributed to durvalumab. c Attributed to nivolumab. d Attributed to erlotinib. e Attributed to osimertinib in combination with durvalumab.