Table 4.
Clinical trials after acquired resistance – EGFR mutant pts
| Phase | Population (no) | Treatment | Primary endpoint |
Results |
|---|---|---|---|---|
| Neratinib | ||||
| 2 | Advanced NSCLC, previous G/E and either A)EGFR+ B)EGFR WT C)light smoker, TKI naïve (n=167) | Neratinib | ORR | Negative, ORR 2%29 |
| Dacomitinib | ||||
| 2 | Advanced NSCLC, KRAS WT, PD on chemo and E (n=65) | Dacomitinib | ORR | Prelim results: 3/62 PR, 35/62 SD34 |
| Afatinib | ||||
| 3 | LUX Lung 1: Adv. adeno w/ POD on platinum based chemo and G/E (n=585) | Afatinib vs Placebo | OS | Negative, OS endpoint not met, although PFS/OR/DCR improved with afatinib41 |
| 1/2 | LUX Lung 4: Asian pts w/ POD on platinum based chemo and G/E (n=90) | Afatinib | Ph1: safety Ph2: ORR |
Prelim results: mPFS 4.4mo, DCR 66%55 |
| 3 | LUX Lung 5: Pts w/ progression on afatinib (n=900, ongoing) | Afatinib +/− Paclitaxel | OS | None, actively recruiting patients |
| 1/2 | Advanced NSCLC, clinically defined AR42 (n=240) | Afatinib + Cetuximab | Ph1: safety Ph2: ORR |
Prelim results: overall PR 35%, 11/35 PR in T790M+46 |
| CO-1686 | ||||
| 1/2 | Advanced EGFR+ NSCLC, previous EGFR TKI (n=70, ongoing) | CO-1686 | Ph1: safety Ph2: ORR |
None, actively recruiting patients |
| XL-647 | ||||
| 2 | Advanced NSCLC, PD on G/E or +T790M (n=41) | XL-647 | ORR | Negative, ORR 3%49 |
| Vandetanib | ||||
| 3 | Advanced NSCLC, previous G/E and chemo (n=924) | Vandetanib vs placebo | OS | Negative, no difference in OS, 8.5mo (V) vs 7.8mo (P), although improved PFS, ORR w/ V52 |
| BMS-690514 | ||||
| 1/2 | Advanced NSCLC, either E naïve or previous E w/ AR (n=60) | BMS-690514 | DCR, safety | Prelim results: DCR 39% (11/28) in E naïve, 22% (7/32) E AR53 |
| AP-26113 | ||||
| 1/2 | Ph1: all advanced malignancies Ph2: Several cohorts including advanced NSCLC w/ AR to EGFR TKI (n=130, ongoing) |
AP 26113 | Ph1: safety Ph2: ORR |
None, actively recruiting patients |