The TROPION-Lung01 study is a multinational Phase III clinical trial comparing the efficacy and safety of a novel antibody-drug conjugate, Datopotamab Deruxtecan (Dato-DXd), with the standard chemotherapy drug Docetaxel in patients with advanced or metastatic non-small cell lung cancer (NSCLC) who have previously undergone treatment. A total of 604 patients were enrolled, with approximately half receiving Dato-DXd and the other half receiving Docetaxel every three weeks. The primary endpoints were progression-free survival (PFS) and overall survival (OS), while objective response rates and safety profiles were also assessed.

Across the entire patient population, Dato-DXd significantly improved median PFS compared to Docetaxel (4.4 months vs. 3.7 months). This effect was especially pronounced in patients with non-squamous histology, where median PFS reached 5.5 months and median OS extended to 14.6 months, demonstrating meaningful improvements over standard treatment. However, in patients with squamous histology, Dato-DXd did not show clear superiority. Although the overall survival was numerically higher in the Dato-DXd group, the difference was not statistically significant.

Regarding safety, Dato-DXd exhibited a generally favorable profile compared to Docetaxel. Grade 3 or higher adverse events occurred in 25.6% of patients treated with Dato-DXd, significantly lower than the 42.1% observed in the Docetaxel group. Notably, drug-related pulmonary toxicities such as interstitial lung disease and pneumonitis were more frequent in the Dato-DXd arm but remained manageable.

In conclusion, Dato-DXd presents a promising new second-line treatment option for patients with previously treated non-squamous NSCLC, offering improved progression-free survival with a manageable safety profile. This study supports the potential of Dato-DXd to become a new standard of care for this patient population.

· Journal : JOURNAL OF CLINICAL ONCOLOGY

· Title : Datopotamab Deruxtecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III TROPION-Lung01 Study

· Link : https://doi.org/10.1200/JCO-24-01544