AstraZeneca and Daiichi Sankyo tout the only treatment with ‘clinically meaningful survival’ in NSCLC

Pharma News: Nearly 2.5 million lung cancer cases were diagnosed globally, with non-small cell lung cancer (NSCLC) being the most common type, accounting for approximately 80% of cases. Although immunotherapy and targeted therapies have improved first-line treatment outcomes, most patients eventually experience disease progression and resort to chemotherapy, which has limited effectiveness and notable side effects.

Overall survival (OS) results from the TROPION-Lung01 Phase III trial were recently unveiled. This trial compared AstraZeneca-Daiichi Sankyo’s TROP2-directed antibody-drug conjugate (ADC) Dato-DXd (datopotamab deruxtecan) with docetaxel in patients with locally advanced or metastatic NSCLC who had been treated with at least one prior line of therapy.

While OS results did not reach statistical significance, in the prespecified subgroup of patients with nonsquamous NSCLC, Dato-DXd showed a clinically meaningful improvement in OS compared to docetaxel, the current standard-of-care chemotherapy.

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 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, Global Head of R&D at Daiichi Sankyo, added, “The improvement in overall survival seen with datopotamab deruxtecan…suggests 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.”

The final analysis of OS builds on the positive progression-free survival (PFS) results presented at the 2023 European Society for Medical Oncology (ESMO) Congress. These results demonstrated a statistically significant improvement in PFS in the overall trial population and a clinically meaningful PFS benefit in patients with nonsquamous NSCLC.

The data from the TROPION-Lung01 trial will support regulatory applications currently under review globally.

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