A Matching-Adjusted Indirect Comparison (MAIC) of Rucaparib vs. Niraparib in the Maintenance Treatment of Advanced Ovarian, Fallopian Tube, and Peritoneal Cancer (aOC) After Response to First-Line Platinum-Based Chemotherapy
Author(s)
Ronald Schwarz, MSc, Dipl. Betriebsw. (FH), CTA1, Ágnes Benedict, MA, MSc2, Pal Rakonczai, PhD3, Balazs Dobi, PhD3, Necdet B. Gunsoy, MPH, PhD4, Virginie Lavaud, MSc5.
1pharmaand Deutschland GmbH, Berlin, Germany, 2PPD Evidera Health Economics & Market Access, Vienna, Austria, 3PPD Evidera Health Economics & Market Access, Budapest, Hungary, 4Evimed Solutions Ltd, Amersham, United Kingdom, 5pharmaand Schweiz GmbH, Zurich, Switzerland.
1pharmaand Deutschland GmbH, Berlin, Germany, 2PPD Evidera Health Economics & Market Access, Vienna, Austria, 3PPD Evidera Health Economics & Market Access, Budapest, Hungary, 4Evimed Solutions Ltd, Amersham, United Kingdom, 5pharmaand Schweiz GmbH, Zurich, Switzerland.
OBJECTIVES: PARP inhibitors have revolutionized the treatment of aOC. Two PARPi therapies, rucaparib and niraparib are licenced for an allcomer population in Europe, based on placebo-controlled randomized trials. The objective of this study is to compare the overall survival (OS) and progression-free survival (PFS) of rucaparib and niraparib in the maintenance treatment of aOC after response to first-line platinum-based chemotherapy using a Matching-Adjusted Indirect Comparison (MAIC).
METHODS: Individual patient data (IPD) from the ATHENA-MONO trial, which compared rucaparib to placebo and aggregate data from PRIMA which compared niraparib to placebo were used. Due to imbalances in the baseline characteristics of the ATHENA-MONO and PRIMA study populations that were considered as important treatment effect modifiers, an anchored MAIC was conducted. The analysis was conducted in the overall biomarker unselected aOC population, and for the non-tBRCA homologous recombination deficient (HRD)-positive subpopulation. The allcomer analysis adjusted for risk classification, ECOG, FIGO stage, neoadjuvant chemotherapy, CA-125 at baseline, HRD/BRCA status, response after platinum-based chemotherapy. For the non-tBRCA HRD+ population only risk category, neoadjuvant chemotherapy, and response after chemotherapy were available. Scenario analyses with different set of EMs were conducted.
RESULTS: After population adjustment rucaparib demonstrated numerically favorable results in allcomer population (PFS HR: 0.60, 95% CI 0.41, 0.87; OS HR: 0.74, 95% CI 0.46, 1.20). In the non-tBRCA HRD-positive population the analysis indicated treatment benefit for rucaparib in terms of PFS (HR) 0.45, 95% Confidence Interval (CI) 0.22 - 0.91, p=0.03) and OS (HR 0.34, 95% CI 0.14 - 0.84. p=0.02) when compared to niraparib. Limitations of the analysis include small effective sample size in the non-tBRCA-HRD+ group and lack of adjustment for ECOG, CA-125 and FIGO stage.
CONCLUSIONS: This MAIC provides robust evidence supporting the therapeutic value of rucaparib in the maintenance treatment of aOC after response to first-line platinum-based chemotherapy.
METHODS: Individual patient data (IPD) from the ATHENA-MONO trial, which compared rucaparib to placebo and aggregate data from PRIMA which compared niraparib to placebo were used. Due to imbalances in the baseline characteristics of the ATHENA-MONO and PRIMA study populations that were considered as important treatment effect modifiers, an anchored MAIC was conducted. The analysis was conducted in the overall biomarker unselected aOC population, and for the non-tBRCA homologous recombination deficient (HRD)-positive subpopulation. The allcomer analysis adjusted for risk classification, ECOG, FIGO stage, neoadjuvant chemotherapy, CA-125 at baseline, HRD/BRCA status, response after platinum-based chemotherapy. For the non-tBRCA HRD+ population only risk category, neoadjuvant chemotherapy, and response after chemotherapy were available. Scenario analyses with different set of EMs were conducted.
RESULTS: After population adjustment rucaparib demonstrated numerically favorable results in allcomer population (PFS HR: 0.60, 95% CI 0.41, 0.87; OS HR: 0.74, 95% CI 0.46, 1.20). In the non-tBRCA HRD-positive population the analysis indicated treatment benefit for rucaparib in terms of PFS (HR) 0.45, 95% Confidence Interval (CI) 0.22 - 0.91, p=0.03) and OS (HR 0.34, 95% CI 0.14 - 0.84. p=0.02) when compared to niraparib. Limitations of the analysis include small effective sample size in the non-tBRCA-HRD+ group and lack of adjustment for ECOG, CA-125 and FIGO stage.
CONCLUSIONS: This MAIC provides robust evidence supporting the therapeutic value of rucaparib in the maintenance treatment of aOC after response to first-line platinum-based chemotherapy.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA9
Topic
Clinical Outcomes, Health Technology Assessment, Methodological & Statistical Research
Topic Subcategory
Value Frameworks & Dossier Format
Disease
Oncology