A Phase 2 Study of Prexasertib in Platinum-Resistant or Refractory Recurrent Ovarian Cancer

Trial ID #	NCT03414047
Phase	II
Drug Class	Cell Cycle Inhibitors: CHK1/2
Drug Name	ACR-368
Alternate Drug Names	checkpoint kinase 1 inhibitor LY2606368, LY2606368, Prexasertib
Drugs in Trial	ACR-368
Eligible Participant	Platinum resistant or refractory ovarian cancer
Patients Enrolled	169
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, DCR, evaluated per RECIST
Efficacy	Pt-R: ORR: 12.1%; DCR: 37.1% Pt-Rf: ORR: 6.9%; DCR: 31.0% BRCA WT, Pt-R ≥ 3 prior therapies (n=53): ORR: 11.3%; w/ or w/o prior PARP inhiibitor: 0 vs 14% BRCA WT, Pt-R < 3 prior therapies: ORR: 13.0% (n=46); w/ or w/o prior PARP inhibitor: 0 vs13.6% BRCA MUT, Pt-R with prior PARP inhibitor: ORR: 12.2% (n=41); w/ or w/o prior bevacizumab: 17.6 vs 8.3% Pt-Rf (n=29): ORR: 6.9% (n=29); w/ or w/o prior bevacizumab: 11.8 vs 0%
Clinically Significant Adverse Events	Serious AE: Grade 3-4 AE: neutropenia (37.9%), thrombocytopenia (17.8%), anemia (10.9%)
Conclusion	ACR-368 (prexasertib) demonstrates durable single agent activity in a subset of patients with platinum resistant HGSOC regardless of clinical characteristics or prior therapy
Reference	Konstantinopoulos PA et al. A Phase 2 study of prexasertib (LY2606368) in platinum resistant or refractory recurrent ovarian cancer. Gynecol Oncol (2022) 167(2):213-225 https://pubmed.ncbi.nlm.nih.gov/36192237/