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Table 2 Clinical trials of CDK4/6 inhibitors in other tumors

From: The application and prospect of CDK4/6 inhibitors in malignant solid tumors

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

  1. 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