AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate (ADC), Datroway (datopotamab deruxtecan), has become the first drug to outperform chemotherapy in immunotherapy-ineligible metastatic triple-negative breast cancer (TNBC).
During the Phase III TROPION-Breast02 trial (NCT05374512), Datroway met its co-primary endpoint – significantly improving overall survival (OS) compared with chemotherapy in the first line.
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The trophoblast cell-surface antigen 2 (Trop2)-targeting drug also hit its second key endpoint during the study, enhancing progression-free survival (PFS) in this TNBC patient subset.
Meanwhile, Datroway’s safety profile remained consistent with previous breast cancer trials involving the drug, with the most common treatment-associated adverse events (TEAEs) being stomatitis, fatigue, and decreased leukocyte levels.
Though the full dataset from this study is yet to be published, AstraZeneca’s executive VP of oncology haemotology R&D, Susan Galbraith, noted that the early findings could “mark an inflection point in the treatment of immunotherapy-ineligible TNBC patients” if the drug were to win approval in this indication.
This could be a notable step forward for patients with TNBC as the current standard of care (SoC) for this patient subset – which constitutes 70% of those diagnosed with TNBC – centres around chemotherapy.
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By GlobalDataThe limited efficacy of other pharmaceutical options is due to the challenging nature of TNBC treatment, as cells of this type lack expression of oestrogen, progesterone and human epidermal growth factor receptor 2 (HER2) receptors. This means that they are immune to the majority of approved breast cancer therapies on the market.
Daiichi and AstraZeneca hope to expand the treatment paradigm with their asset, with the duo planning to engage with global regulators to facilitate a label expansion for Datroway in TNBC.
This would add to the ADC’s two current label indications, which stemmed from accelerated approvals in second-line breast cancer and third-line non-small cell lung cancer (NSCLC).
ADCs reign in TNBC
If Datroway was to get the US Food and Drug Administration (FDA) go-ahead, it would join Gilead’s blockbuster Trop2-targeting ADC, Trodelvy (sacituzumab govitecan), on the market.
However, Datroway would likely offer fierce competition to the market resident, as Trodelvy is generally confined to third line treatment and beyond, with the drug only being used off-label in first-line TNBC.
As Datroway will be able to further penetrate the TNBC market, analysts at GlobalData, parent company of Clinical Trials Arena, forecast that the drug will hit blockbuster status after just two years on the market.
They also predict a steep growth trajectory for the drug, with the 2031 sales estimate sitting at $3.1bn. This figure eclipses the $2.3bn Trodelvy forecast for the same year.
