
AstraZeneca shares results from phase 3 TROPION-Lung01 trial
Betsy Goodfellow | May 28, 2024 | News story | Medical Communications | AstraZeneca, Daiichi Sankyo, NSCLC, Oncology, clinical trial, datopotamab deruxtecan
AstraZeneca has announced results from the phase 3 TROPION-Lung01 trial of AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan (Dato-DXd). The survival results did favour the drug however they did not reach statistical significance.
The high-level overall survival (OS) results favoured Dato-DXd for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have been treated with at least one prior line of therapy. In a prespecified subgroup of patients with nonsquamous NSCLC, the drug showed a clinically meaningful improvement in OS compared to the current standard-of-care chemotherapy.
The drug’s trial previously met its dual primary endpoint of progression-free survival (PFS) in the overall trial population.
Susan Galbraith, executive vice president of Oncology R&D at AstraZeneca, commented: “Datopotamab deruxtecan is the only investigational therapy to show a clinically meaningful survival improvement in patients with previously treated NSCLC 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.”
Ken Takeshita MD, global head of R&D at Daiichi Sankyo, added: “The improvement in OS seen with datopotamab deruxtecan coupled with the previously reported clinically meaningful PFS, more than doubling of overall response and prolonged duration of response compared to docetaxel suggest that this TROP2-directed antibody drug conjugate could potentially become an important new treatment for patients with NSCLC in this advanced setting. These data will support our ongoing discussions with regulatory authorities globally to potentially bring datopotamab deruxtecan to patients as quickly as possible and mark another step forward in creating new standards of care for patients with cancer.”
Betsy Goodfellow
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