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Durvalumab and Cediranib with and without Olaparib in Recurrent Ovarian Cancer: A phase II Proof-of-Concept Study

We report the efficacy and translational research findings of durvalumab, olaparib, and cediranib (D+O+C) and durvalumab and cediranib (D+C) therapies from the recurrent epithelial ovarian cancer (EOC) cohort within a single center, multi-arm, non-randomized, multi-cohort phase I/II trial (NCT02484404). Sixty-eight patients were enrolled (39 in D+O+C, 29 in D+C). The objective response rate (ORR) was 19.4% (95% CI, 9.5-43.5) for D+O+C and 29.6% (95% CI, 13.8-46.9) for D+C. Median progression-free survival (PFS) was 4.5 months in both arms, with each arm including four exceptional responders (PFS ≥ 12 months).

Pre-treatment biopsies and paired normal peripheral blood mononuclear cells (PBMC) samples for whole exome sequencing (WES) were available for 31 patients in the D+O+C and 24 in the D+C, the remaining 13 patients were not biopsied due to safety concerns or being off treatment. WES was conducted to explore genomic profiles for potential correlations with clinical benefit (CB; partial response or stable disease [SD] with PFS ≥ 4 months) or no clinical benefit (NCB; progressive disease or SD with PFS < 4 months).

TP53 mutations were found in most cases in both D+O+C and D+C arms. Overall, no consistent associations between baseline genomic alterations and CB were observed.