Combination ATR and PARP Inhibition Under Study in Relapsed Ovarian Cancer
Posted: Tuesday, December 8, 2020
The combination of the ATR inhibitor ceralasertib and the PARP inhibitor olaparib may prove to be beneficial when treating patients with platinum-sensitive relapsed epithelial ovarian cancer, according to researchers from Princess Margaret Cancer Centre, Toronto. The details of the phase II randomized, multicenter DUETTE trial were published in the International Journal of Gynecological Cancer.
“DUETTE is uniquely positioned in this setting to elucidate whether second maintenance treatment can transform survival in a platinum-sensitive relapsed ovarian cancer population who have specifically received prior PARP inhibitor treatment,” stated Amit Oza, MD, and colleagues.
The patients will include women with histologically diagnosed high-grade epithelial ovarian cancer with platinum-sensitive relapse. Participants must have completed at least 6 months of any prior PARP inhibitor maintenance therapy to be enrolled. Patients will be randomly assigned to groups that receive either ceralasertib treatment in addition to olaparib, olaparib monotherapy, or a placebo.
The study authors predict that patients treated with ceralasertib and olaparib or olaparib monotherapy may see an improvement in progression-free survival compared with patients given a placebo. Olaparib and placebo groups will be double-blinded, whereas the ceralasertib-plus-olaparib group will be open-label. The primary endpoint of progression-free survival will be blindly reviewed. Secondary endpoints include overall survival, time to second objective disease progression, objective response rate, duration of response, safety, and tolerability. Further, the researchers will assess the genetic and nongenetic drivers of PARP inhibitor resistance and predictive biomarkers of response.
Disclosure: For full disclosures of the study authors, visit ijgc.bmj.com.