COMPARATIVE EFFICACY AND SAFETY OF OLAPARIB 400 MG CAPSULES BID AND NIRAPARIB 300 MG TABLETS QD AS MAINTENANCE TREATMENT AFTER RESPONSE TO CHEMOTHERAPY IN PATIENTS WITH PLATINUM-SENSITIVE RELAPSED NON-GERMLINE BRCA-MUTATED OVARIAN CANCER (P ...

Author(s)

Sackeyfio A1, Gill J2, Hettle R3, Siddiqui K2, Friedlander M4, Ledermann JA5
1AstraZeneca, Cambridge, UK, 2PAREXEL International, Chandigarh, India, 3PAREXEL International, London, UK, 4University of New South Wales Clinical School, New South Wales, Australia, 5University College London, London, UK

OBJECTIVES: Maintenance therapy with a poly(ADP-ribose) polymerase inhibitor (PARPi), following response to platinum-based chemotherapy, significantly extends progression-free survival (PFS) and time to first subsequent treatment or death (TFST) in germline BRCA-mutated (gBRCAm) platinum-sensitive relapsed ovarian cancer (PSROC). Statistically significant treatment benefit has also been observed in patients without a gBRCAm, suggesting sensitivity to PARPis in non-gBRCAm patients. Comparative efficacy and safety of different PARPis in non-gBRCAm is currently unknown. An indirect treatment comparison (ITC) of niraparib tablets and olaparib capsules, using data from ENGOT-OV16/NOVA and Study 19 (NCT00753545/S19) clinical studies, respectively, was conducted.

METHODS: A Bayesian ITC was performed on efficacy and safety on the non-gBRCA data from NOVA (niraparib) and gBRCA wild type data from S19 (olaparib). Efficacy analyses compared investigator (INV) and independent review committee (IRC) assessed PFS hazard ratios (HR) and TFST HR. Safety analyses included odds ratios (OR) of any grade ≥3 adverse event (AE), AEs leading to dose interruption, reduction, and discontinuation.

RESULTS: HRs comparing olaparib and niraparib were 0.94 (95% credible interval 0.54–1.65) for investigator-assessed PFS, and 1.25 (0.67–2.30) for IRC PFS. TFST HR was 0.78 (0.47–1.30). No significant difference in efficacy between PARPi was observed. The corresponding ORs for AE were 0.34 (0.13–0.90), 0.54 (0.16–2.06), 0.16 (0.01–2.18) and 0.21 (0.04–1.21) for any grade ≥3 AE, and AE leading to dose interruption, discontinuation, and reduction, respectively. There was a significant reduction in the odds of any grade ≥3 AE. No significant difference in AE leading to dose interruption, reduction, and discontinuation.

CONCLUSIONS: ITC shows no significant difference in efficacy between olaparib capsules and niraparib tablets as maintenance therapy in patients with non-gBRCAm PSROC following response to chemotherapy. Olaparib shows significantly reduced odds compared with niraparib for any grade ≥3 AE. No significant difference was observed in AEs leading to modification in drug administration.

Conference/Value in Health Info

2017-11, ISPOR Europe 2017, Glasgow, Scotland

Value in Health, Vol. 20, No. 9 (October 2017)

Code

PCN5

Topic

Clinical Outcomes, Epidemiology & Public Health

Topic Subcategory

Comparative Effectiveness or Efficacy, Safety & Pharmacoepidemiology

Disease

Oncology

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