DESTINY-Breast03 Phase 3 Study Results
Background
Combining immune checkpoint inhibitors with 1st-line chemotherapy improves outcomes in patients with
advanced/metastatic triple-negative breast cancer (a/mTNBC), but only in PD-L1-positive disease 1.2
◆ Datopotamab deruxtecan (Dato-DXd), a TROP2-directed antibody-drug conjugate (ADC) with topoisomerase |
inhibitor payload, demonstrated promising antitumor activity as monotherapy in heavily pretreated patients with
recurrent a/mTNBC³
BEGONIA is an ongoing 2-part, open-label platform study evaluating durvalumab, an anti-PD-L1 antibody,
combined with other therapies, including ADCs, as 1st-line treatment of a/mTNBC in a biomarker unselected
population
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In the paclitaxel + durvalumab arm, a confirmed ORR of 58.3% was demonstrated and responses were
durable (median PFS: 7.3 mos., 95% CI 5.4-13.8)4, consistent with reported response rates for immune
checkpoint inhibitors in first-line mTNBC and independent of PD-L1 status.
In the trastuzumab deruxtecan + durvalumab arm, a confirmed ORR of 66.7% was demonstrated, with
87.5% of patients remaining in response at time of data cutoff
We report preliminary results with Dato-DXd + durvalumab in BEGONIA, the first data with this novel
combination in patients with newly diagnosed a/mTNBC
1. Cortes J, et al. Lancet. 2020,396(10265): 1817-1828.
2. Emens LA, et al. J Natl Cancer Inst. 2021;113(8):1005-1016.
3. Krop I, et al. Cancer Res. 2022;82(Suppl 4):GS1-05.
ESMO BC 2022 #166 Mini Oral PD-L1, programmed cell death ligand-1; TROP2, trophoblast cell-surface antigen 2.
Daiichi-Sankyo
4. Schmid P, et al. Presented at 2021 SABCS Annual Meeting, Poster PD 10-03.
5. Schmid P, et al. Presented at 2021 ASCO Annual Meeting, Poster 1023.
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