An Open Label, Single Arm, Multicentre Study to Assess the Clinical Effectiveness and Safety of Lynparza (Olaparib) Capsules Maintenance Monotherapy in Platinum Sensitive Relapsed Somatic or Germline BRCA Mutated Ovarian Cancer Patients Who Are in Complete or Partial Response Following Platinum Based Chemotherapy (ORZORA).

Trial ID #	NCT02476968; ORZORA
Phase	IV
Drug Class	DNA Damage Repair Pathway Inhibitors: PARP
Drug Name	Olaparib
Alternate Drug Names	AZD2281, Lynparza
Drugs in Trial	Olaparib
Eligible Participant	Platinum sensitive ovarian cancer with mutations in ATM, BARD1, BRCA1/2, BRIP1,CDK12, CHEK1/2, FANCL, PALB2, PPP2R2A, or RAD51B/C/D/L and with CR or PR to last platinum regimen
Patients Enrolled	181
Therapy Setting	Maintenance
Study Design	Open-Label, Non-randomized
Endpoints	PFS, evaluated per RECIST
Biomarkers	gBRCA status, sBRCA status, HRRm (13 gene panel)
Efficacy	gBRCA MUT (n=87) vs sBRCA MUT (n=55) vs HRRm (n=33): PFS: 18.0 vs 16.6 vs 16.4 months
Clinically Significant Adverse Events	gBRCA MUT vs sBRCA MUT vs HRRm: Serious AE: patients w/ AML: 2 vs 0 vs 0 Grade 3-4 AE: anemia (15.8%) (no difference between arms)
Conclusion	PFS in patients with platinum sensitive ovarian cancer who received maintenance olaparib is similar irrespective of somatic or germline BRCA status and activity of maintenance olaparib is also seen in patients with a non-BRCA HRR gene mutation
Reference	Pignata S et al. ORZORA: Maintenance olaparib in patients with platinum-sensitive relapsed ovarian cancer: Outcomes by somatic and germline BRCA and other homologous recombination repair gene mutation status. SGO (2021) abstract 10503 https://www.clearityfoundation.org/wp-content/uploads/2021/03/SGO-10503-ORZORA-Pignata.pdf