Datopotamab Deruxtecan Showed Clinically Meaningful Overall Survival Improvement Versus Chemotherapy in Patients with Advanced Nonsquamous Non-Small Cell Lung Cancer in TROPION-Lung01 Phase 3 Trial

Topline overall survival (OS) results from the TROPION-Lung01 phase 3 trial, which previously met the dual primary endpoint of progression-free survival (PFS), numerically favored datopotamab deruxtecan (Dato-DXd) compared to docetaxel in the overall trial population of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) treated with at least one prior line of therapy. Survival results did not reach statistical significance in the overall trial population. In the pre-specified subgroup of patients with nonsquamous NSCLC, datopotamab deruxtecan showed a clinically meaningful improvement in OS compared to docetaxel, the current standard of care chemotherapy.

Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).

The final analysis of OS builds on the positive PFS results presented at the European Society for Medical Oncology (#ESMO23) 2023 Congress which showed 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. In TROPION-Lung01, patient enrollment by tumor histology was balanced across treatment arms and consistent with real world incidence with approximately 75% of patients having nonsquamous NSCLC.^1,2

The safety profile of datopotamab deruxtecan in TROPION-Lung01 was consistent with the previous analysis, including fewer dose reductions or discontinuations due to adverse events compared to docetaxel and with no new safety concerns identified. No new interstitial lung disease events of any grade were adjudicated as drug-related.

"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 metastatic setting,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “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.”