Table 2.
CDK inhibitors | Study ID | Phase | Lines | Patients | Regimens | Efficacy |
---|---|---|---|---|---|---|
Palbociclib | NCT01209598 [47] | II | Non-first line | Advanced WD/DDLS | Palbociclib (n = 60) | PFS at 12 weeks 57.2%; mPFS 17.9 weeks |
NCT02101034 [46] | II | Non-first line | HNSCCs | Palbociclib + cetuximab (n = 62) | ORR 39% (in platinum-resistant patients), ORR 19% (in cetuximab-resistant patients) | |
NCT01037790 (recruiting) | II | UK | RB/germ cell tumors | Palbociclib (n = 205) | PFS at 6 months 28%; mPFS 11 weeks | |
NCT01536743 (active, not recruiting) | II | Non-first line | Ovarian epithelial carcinoma | Palbociclib (n = 26) | PFS at 6 months 15% | |
NCT00420056 [48] | Ib | UK | MCL | Palbociclib (n = 17) | 6% CR, 12% PR, 41% SD, mPFS 4.0 m | |
Ribociclib | CLEE011X2105 [45] | Ib/II | Non-first line | BRAF V600-mutant melanoma | Ribociclib (n = 18) | 2 PR, 6 SD |
CMEK162X2114 [49] | Ib/II | UK | NRAS-mutant melanoma | Ribociclib + binimetinib (n = 22) | 7 PR, 11 SD, 33% had 20–30% tumor shrinkage | |
Abemaciclib | NCT01394016 [44] | I | UK | Breast cancer; NSCLC; Melanoma; Glioblastoma; CRC | Abemaciclib (n = 225) | Breast cancer (n = 47) 23% PR, 47% SD, 23% ORR, 49% CBR, 70%DCR, mPFS 5.8 m; NSCLC (n = 68), 3% PR, 46% SD, 3% ORR, 49% DCR, mPFS 2.0 m; melanoma (n = 26) 4% PR, 23% SD, 4% ORR, 27% DCR; glioblastoma (n = 17) 18% SD, 18% DCR; CRC (n = 15) 13% SD, 13% DCR |
NCT02014129 [50] | I | Non-first line | Various advanced cancer | Abemaciclib (n = 12) | tumor size changed from 35% decrease to 25% increase, > 30% tumor shrinkage in 2 patients |
WD/DDLS well-differentiated or dedifferentiated liposarcoma, HNSCCs head and neck squamous-cell carcinomas, Rb retinoblastoma, MCL mantle cell lymphoma, NSCLC non-small-cell lung cancer, CRC colorectal cancer, UK unknown, PFS progression-free survival, OS overall survival, ORR objective response rate, DCR disease control rate, CR complete response, PR partial response, SD stable disease, HR hazard ratio