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 Lynparza, AZD2281
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

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