Drug Class: Cell Cycle Inhibitors

Cell Cycle Inhibitors: CDK4/6 Inhibitors

Treatment given for recurrence occurring at any time after last platinum-based treatment

Objective Response Rate (%)

Percentage of patients whose tumors shrink or go away after treatment

Progression Free Survival (months)

Median length of time before the cancer comes back or gets worse

3 Prior Therapies

Cell Cycle Inhibitors: CDK4/6 Inhibitors

Treatment given for recurrence occurring at any time after last platinum-based treatment

For more detailed information, please click on the clinical trial ID number.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
NCT01536743 II Palbociclib A Open Label Phase II Study of the Efficacy and Safety of PD0332991 a Selective Inhibitor of the Cyclin Dependent Kinases 4 and 6 in Patients With Recurrent Ovarian Cancer Demonstrating Rb-proficiency and Low p16 Expression

Palbociclib has modest single agent activity in unselected patients, but shows encouraging activity in patients with CDKN2A loss or CDK6 AMP

ORR: 6%
PFS: 3.1 months

6 patients w/ response by CA125 or RECIST:
1 w/ CDKN2A loss, 1 w/CDKN2A loss and CCNE AMP, 1 w/ CDK6 AMP and NRAS AMP and BRAF AMP

abs Jun 2016 and poster

NCT02657928 II Letrozole, Ribociclib A Phase 2 Trial of Ribociclib (LEE011) and Letrozole in ER Positive Relapsed Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinomas, and Endometrial Cancers.

Ribociclib+letrozole is active in ER+ ovarian cancer with 25% achieving PFS for 23 weeks or longer, but greatest benefit is seen in low grade serous (LGS) ovarian cancer

ORR (HGS): 0%
ORR (LGS): 100% (n=3)
PFS ≥ 23 weeks: 25%

abs May 2019 and presentation

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