February 18 2025
During the NRG Oncology 2025 Winter Meeting in January, NRG Oncology activated the NRG-GY036 clinical study: the group’s first pragmatic study conducted in a real-world clinical practice setting with streamlined data collection. NRG-GY036 is a phase III study comparing the difference between one year and two years of maintenance Olaparib, with or without bevacizumab, in patients with BRCA1/2 mutated or homologous recombination deficient (HRD+) ovarian cancer following response to first line platinum-based chemotherapy.
“Although the phase III studies SOLO1 and PAOLA-1 established the progression-free survival benefit of two years of olaparib maintenance, with or without bevacizumab, in BRCA1/2 mutated and HRD+ ovarian cancer, there are also known long-term toxicities associated with PARP inhibitors,” stated Ying Liu, MD, MPH, at the Memorial Sloan Kettering Cancer Center (MSKCC) and the Principal Investigator of NRG-GY036. “NRG-GY036 aims to address if de-escalation of Olaparib therapy is possible without sacrificing efficacy.”
Patients enrolled onto NRG-GY036 will be randomly assigned to receive either Olaparib twice daily for TWO years or for ONE year, with or without bevacizumab. The primary endpoint is to determine investigator assessed progression-free survival (PFS) between the two treatment schedules. This analysis is supported by a modified intention-to-treat (mITT) population limited to patients on protocol at least 360 days after randomization. The time at risk for this population starts 360 days after randomization. Patients will be stratified by BRCA mutation status, by use of bevacizumab, and by response to platinum-based therapy.
In addition to the primary objective of this study, this trial also has several secondary, exploratory, and translational aims. Secondary aims include the evaluation of overall survival (OS) in the mITT population, PFS, PFS2, and OS in the intention-to-treat (ITT) and as-treated populations, and toxicity in the safety population, particularly rates of MDS/AML. Exploratory objectives include evaluating the moderating effect of physician-choice bevacizumab on outcomes. Lastly, the translational aims of this study are to collect baseline tumor and longitudinal peripheral blood samples to look for markers of PARP inhibitor resistance. As a streamlined study, data collection and adverse event reporting will be minimized and only focus on areas that are necessary for eligibility and study endpoints. This will hopefully make the study more accessible to patients and study sites.
“This trial is exceedingly important as clinical research begins to shift the paradigm from a controlled environment and population to engaging larger populations and accelerating the integration of research, policy, and practice – especially in the research landscape of ovarian cancer which has several disparities present through race and socioeconomic factors,” added Carol Aghajanian, MD, at the MSKCC and the Co-Principal Investigator of NRG-GY036.
More Study Information
Learn more about this trial at ClinicalTrials.gov
Protocol documents and materials are located on the CTSU website