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 Lynparza, AZD2281
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+ 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 KA et al. Olaparib treatment in patients (pts) with platinum-sensitive relapsed (PSR) ovarian cancer (OC) by BRCA mutation (BRCAm) and homologous recombination deficiency (HRD) status: Phase II LIGHT study. J Clin Oncol (2020) 38: (suppl; abstr 6013)
https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.6013

Cadoo KA et al. Poster
https://www.clearityfoundation.org/wp-content/uploads/2020/07/Olaparib-LIGHT-study-ASCO-2020.pdf