American Association for Cancer Research
ccr-23-2513_supplementary_data_1_suppds1.pdf (1.38 MB)

Supplementary Data 1 from Phase II DORA Study of Olaparib with or without Durvalumab as a Chemotherapy-Free Maintenance Strategy in Platinum-Pretreated Advanced Triple-Negative Breast Cancer

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posted on 2024-04-01, 07:22 authored by Tira J. Tan, Sarah Sammons, Young-Hyuck Im, Lilin She, Kelly Mundy, Robert Bigelow, Tiffany A. Traina, Carey Anders, Joe Yeong, Ezequiel Renzulli, Sung-Bae Kim, Rebecca Dent



AstraZeneca Pharmaceuticals

Duke Cancer Institute (DCI)

Duke-NUS Medical School (DukeNUS)

National Medical Research Council (NMRC)

Tempus Labs



We explored the efficacy of PARP inhibition with or without programmed death ligand-1 (PD-L1) blockade as chemotherapy-free maintenance therapy for advanced triple-negative breast cancer (aTNBC) sensitive to platinum-based chemotherapy. In the phase II non-comparative DORA trial (NCT03167619), patients with ongoing stable disease (SD) or complete/partial response (CR/PR) to first- or second-line platinum-based chemotherapy for TNBC (≤10% estrogen/progesterone receptor expression) were randomized 1:1 to receive olaparib 300 mg twice daily with or without durvalumab 1,500 mg on day 1 every 4 weeks. The primary objective was to compare progression-free survival (PFS) versus a historical control of continued platinum-based therapy. 45 patients were randomized (23 to olaparib alone, 22 to the combination; 3 with estrogen/progesterone receptor expression 1%–10%). At 9.8 months’ median follow-up, median PFS from randomization was 4.0 [95% confidence interval (CI), 2.6–6.1] months with olaparib and 6.1 (95% CI, 3.7–10.1) months with the combination, both significantly longer than the historical control (P = 0.0023 and P < 0.0001, respectively). Clinical benefit rates (SD ≥24 weeks or CR/PR) were 44% (95% CI, 23%–66%) and 36% (95% CI, 17%–59%) in the monotherapy and combination arms, respectively. Sustained clinical benefit was seen irrespective of germline BRCA mutation or PD-L1 status, but tended to be associated with CR/PR to prior platinum, particularly in the olaparib-alone arm. No new safety signals were reported. PFS was longer than expected with both regimens. A patient subset with wild-type BRCA platinum-sensitive aTNBC had durable disease control with chemotherapy-free maintenance.

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