Positive late-stage trial result for AZ-Daiichi Sankyo antibody-drug conjugate

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AstraZeneca has announced positive results from a late-stage trial of its datopotamab deruxtecan in development under a collaboration with Daiichi Sankyo.

Datopotamab deruxtecan is an investigational TROP2-directed antibody-drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed with AstraZeneca.

AstraZeneca announced that overall survival results from the Phase 3 trial favoured datopotamab deruxtecan compared to docetaxel in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) treated with at least one prior line of therapy.

"In the prespecified subgroup of patients with nonsquamous NSCLC, datopotamab deruxtecan showed a clinically meaningful improvement in OS compared to docetaxel, the current standard-of-care chemotherapy," said the company.

According to Susan Galbraith, AstraZeneca's executive vice president of Oncology R&D, “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.”

Dr Ken Takeshita, Daiichi Sankyo's global head of R&D, said, “The improvement in overall survival seen with datopotamab deruxtecan coupled with the previously reported clinically meaningful progression-free survival, 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 nonsquamous non-small cell lung cancer 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.”