Table 2.
Studies of Monoclonal Antibodies in HER2 altered NSCLC.
| Drug | Trial | NSCLC Population (n) | Overall Response Rate | Median PFS (Months) | Median OS (Months) | Ref |
|---|---|---|---|---|---|---|
| trastuzumab | phase II (HOT1303-B) |
HER2 IHC 2/3+ or mutation (n = 10) |
0% | 5.2 | n/a | [24] |
| trastuzumab ± docetaxel | phase II | HER2 IHC 2/3+ (n = 13) |
Trastuzumab: 0% Trastuzumab + docetaxel: 0% |
n/a a | 5.7 | [25] |
| trastuzumab + cisplatin/ gemcitabine |
phase II | HER2 IHC 1+ or HER2 shed antigen level >15 ng/mL by ELISA (n = 21) |
38% | 36 weeks | n/a | [27] |
| trastuzumab + paclitaxel/ carboplatin |
phase II (ECOG 2598) |
HER2 IHC ≥ 1+ (n = 56) |
24.5% | 3.3 | 10.1 | [26] |
| gemcitabine/cisplatin ± trastuzumab | phase II | HER2 IHC 2/3+, HER2/CEP17 ratio ≥ 2, Serum HER2 ECD >15 ng/mL by ELISA (n = 101) |
Control arm: 41% (50% in HER2 IHC 3+) Trastuzumab arm: 36% (83% in HER2 IHC 3+) |
Control arm: 7.0 Trastuzumab arm: 6.1 |
Control arm: n/r Trastuzumab arm: 12.2 |
[28] |
| pertuzumab + trastuzumab + docetaxel | phase II (IFCT-1703 R2D2) |
HER2 exon 20 mutation (n = 45) |
29% | 6.8 | n/a | [29] |
PFS: progression free survival; OS: overall survival; IHC: immunohistochemistry; CEP17: chromosome enumeration probe 17; ECD: extracellular domain; n/a: not available; n/r: not reached. a Event free survival was 4.3 months.