AstraZeneca and Daiichi Sankyo have reported high-level overall survival (OS) results from the Phase III TROPION-Lung01 clinical trial of datopotamab deruxtecan in patients with advanced nonsquamous non-small cell lung cancer (NSCLC).
Datopotamab deruxtecan is a trophoblastic cell surface antigen 2 (TROP-2) antibody-drug conjugate.
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The randomised, global, multicentre, open-label trial assessed the efficacy and safety of datopotamab deruxtecan versus chemotherapy with docetaxel.
It enrolled adults with locally advanced or metastatic NSCLC irrespective of their actionable genomic alterations status and needed systemic therapy following prior therapy.
Progression-free survival (PFS) and OS were the trial’s dual primary endpoints.
Key secondary endpoints included objective response rate, investigator-assessed PFS, duration of response, time to response, disease control rate and safety.
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By GlobalDataApproximately 600 patients across Asia, Europe, North America, and South America participated in the TROPION-Lung01 trial, which had previously met its primary endpoint of PFS.
The latest findings indicated that high-level OS results numerically favoured datopotamab deruxtecan over docetaxel in the overall trial population, although statistical significance was not reached.
However, in a prespecified subgroup of patients with nonsquamous NSCLC, datopotamab deruxtecan showed a clinically meaningful improvement in OS compared to docetaxel.
This builds upon the positive PFS results previously presented, where datopotamab deruxtecan demonstrated a statistically significant improvement in PFS in the overall trial population and a clinically meaningful PFS benefit in patients with nonsquamous NSCLC.
Datopotamab deruxtecan’s safety profile was found to be in line with previous analyses, showing fewer dose reductions or discontinuations due to adverse events versus docetaxel.
Furthermore, no new safety concerns and drug-related interstitial lung disease events were reported in the trial.
Discovered by Daiichi Sankyo, Datopotamab deruxtecan is being co-developed by AstraZeneca and Daiichi Sankyo.
The latest trial data will support regulatory applications currently under review globally, including in the US and EU, in this indication.
AstraZeneca Oncology R&D executive vice-president Susan Galbraith said: “Datopotamab deruxtecan is the only investigational therapy to show a clinically meaningful survival improvement in patients with previously treated nonsquamous non-small cell lung cancer versus docetaxel, which has long been unsurpassed in this post-targeted treatment and post-immunotherapy setting.
“These results reinforce the potential for datopotamab deruxtecan to replace conventional chemotherapy in this late-line setting and underscore our confidence in ongoing trials evaluating this therapy in first-line lung cancer.”
In April this year, AstraZeneca and Daiichi Sankyo announced that Enhertu offered a statistically and clinically meaningful PFS improvement in patients with HR-positive, HER2-low metastatic breast cancer.
