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

1 Prior Therapy 3 Prior Therapies

Cell Cycle Inhibitors: CDK4/6 Inhibitors

Neo adjuvant (before surgery) and first-line treatment with/without extended (maintenance) 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
NCT03531645 II Abemaciclib, Fulvestrant A Pilot Phase II Study of Neoadjuvant Fulvestrant Plus Abemaciclib in Women With Advanced Low Grade Serous Carcinoma

Neoadjuvant treatment with fulvestrant and abemaciclib is tolerable and demonstrates unprecedented response and complete gross resection rates in Low Grade Serous OC

ORR: 60% (n=15)
DCR: 100%

7 patients w/ IDS:
100% achieved optimal cytoreduction at IDS
(71% R0, 29% R1)

abs Jun 2022 and poster

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+ OC with 25% achieving PFS for 23 weeks or longer, but greatest benefit is seen in LGSOC

ORR (HGSOC): 0%
ORR (LGSOC): 100% (n=3)
PFS ≥ 23 weeks: 25%

abs May 2019 and presentation

NCT03673124 II Letrozole, Ribociclib A Phase II Trial of Ribociclib (LEE011) Plus Letrozole in Women With Recurrent Low-Grade Serous Carcinoma of the Ovary, Fallopian Tube or Peritoneum

The combination of letrozole plus ribociclib demonstrates promising activity in women with recurrent LGSOC

ORR: 23%
DCR: 79%
DoR: 19.1 months
PFS: 19.1 months

abs Mar 2023 and presentation

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