Non-Randomized, Open-Label Phase II Study to Assess Olaparib Tablets as a Treatment for Subjects With Different HRD Tumor Status and With Platinum-Sensitive, Relapsed, High-Grade Serous or High-Grade Endometrioid Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer That Have Received at Least 1 Prior Line of Chemotherapy

Trial ID #	NCT02983799; LIGHT
Phase	II
Drug Class	DNA Damage Repair Pathway Inhibitors: PARP
Drug Name	Olaparib
Alternate Drug Names	AZD2281, Lynparza
Drugs in Trial	Olaparib
Eligible Participant	Platinum sensitive recurrent ovarian cancer
Patients Enrolled	270
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, DCR, PFS, evaluated per RECIST
Biomarkers	Exploratory: HRD status; HRD+ defined by Myriad myChoice test score ≥ 42
Efficacy	gBRCA MUT (n=75): ORR: 69%; DCR: 96%; PFS: 11.0 months sBRCA MUT (n=25): ORR: 64%; DCR: 100%; PFS: 10.8 months HRD+ (excl. BRCA MUT, n=68): ORR: 29%; DCR: 79%; PFS: 7.2 months HRD- (n=89): ORR: 10%; DCR: 75%; PFS: 5.4 months
Clinically Significant Adverse Events	Serious AE: Grade 3-4 AE:
Conclusion	Olaparib treatment has activity across all cohorts with similar efficacy in the gBRCA MUT and sBRCA MUT cohorts. For non-BRCA MUT patients, longer median PFS and higher ORR are observed in the HRD+ cohort
Reference	Cadoo K et al. Olaparib treatment for platinum-sensitive relapsed ovarian cancer by BRCA mutation and homologous recombination deficiency status: Phase II LIGHT study primary analysis. Gynecol Oncol (2022) 166(3):425-431 https://pubmed.ncbi.nlm.nih.gov/35803835/