Background: Carboplatin-paclitaxel is standard of care for recurrent/advanced EC for which surgery AE radiation are not curative. Dostarlimab is an antieprogrammed cell death 1 (PD-1) humanized monoclonal antibody that showed antitumor activity and an acceptable safety profile in patients (pts) with recurrent or advanced EC in the GARNET trial. Niraparib is a PARP inhibitor (PARPi) approved as 1L maintenance therapy in pts with advanced ovarian cancer following response to platinum-based chemo. Based on mechanism of action and preclinical findings, PARPi are being investigated for use in EC. RUBY part 2 will evaluate the efficacy and safety of
Annals of Oncology abstracts S770Volume 32 -Issue S5 -2021
subgroups, including by presence of genome-wide loss of heterozygosity, will be presented. Table: 814MO Non-gBRCAm PSR OC Doublet cohort (O+D) n[32 Triplet cohort (O+D+B) n[31 24-w DCR, % 28.1% (90% CI 15.5e43.9) 77.4% (90% CI 61.7e88.9) Confirmed ORR, % 31.3% (95% CI 16.1e50.0) 77.4% (95% CI 58.9e90.4) Median confirmed DOR (mo)6.9 (IQR 5.7e11.1) 11.1 (IQR 9.0e16.4)Median PFS (mo) 5.5 (95% CI 3.6e7.5) 14.7 (95% CI 10.0e18.1) CI, confidence interval; IQR, interquartile range.Conclusions: Combining O+D and O+D+B was well tolerated in pts with non-gBRCAm PSR OC, consistent with the known safety profiles of the single agents. The DCR for the doublet cohort did not meet the prespecified target of 80%. The 95% CI for DCR in the triplet cohort included the prespecified target of 80%. ORR and PFS in the triplet cohort demonstrate promising activity in non-gBRCAm PSR OC, and in this group the ORR and PFS are higher than reported for single-agent PARP or VEGF inhibitors.Clinical trial identification: NCT02734004.
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