The findings from the TROPION-Lung01 study challenges the current standard of care for previously treated non-small cell lung cancer (NSCLC) patients and provides evidence for the potential role of TROP2-directed antibody drug conjugates in treating lung cancer. The study also highlights the need for new treatment options for NSCLC patients who have progressed after platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor. Learn more about the findings and implications from this study with this brief recap.
More than one million people worldwide are diagnosed with advanced non-small cell lung cancer (NSCLC) each year. While targeted therapies have improved outcomes in the first-line metastatic setting, most patients will eventually experience disease progression and receive chemotherapy.
Patients with advanced NSCLC have limited treatment options, but the recent TROPION-Lung01 study provides compelling evidence for the potential role that datopotamab deruxtecan (Dato-DXD), a TROP2-directed antibody-drug conjugate, can play in treating patients with lung cancer.
Here's an in-depth look at this study.
The Design of the TROPION-Lung01 Study
The TROPION-Lung01 study is a phase III, randomized, open-label clinical trial that evaluated the efficacy and safety of Dato-DXd versus docetaxel in patients with advanced or metastatic NSCLC who had previously been treated with platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor. The study enrolled approximately 600 patients at sites in all parts of the world, including Asia, Europe, North America, and South America.
The treatment regimen for the study was as follows:
- Arm A: Patients received Dato-DXD at a dose of 6.0 mg/kg every three weeks until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
- Arm B: Patients received docetaxel at a dose of 75 mg/m2 every three weeks until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
The Results of the TROPION-Lung01 Study
The results of the TROPION-Lung01 study showed that Dato-DXD reduced the risk of disease progression or death by 25 percent in the overall population, meeting the dual primary endpoint of progression-free survival (PFS). The median PFS was 4.4 months for patients treated with Dato-DXD and 3.7 months for those treated with docetaxel.
Other efficacy results showed that Dato-DXD had a higher confirmed objective response rate compared to docetaxel (26.4 percent versus 12.8 percent), with a higher complete response rate (1.3 percent versus 0 percent) and partial response rate (25.1 percent versus 12.8 percent). The median duration of response was also longer for patients treated with Dato-DXD (7.1 months versus 5.6 months).
The safety profile of Dato-DXD was consistent with previous studies, with the most common adverse events being nausea, decreased appetite, fatigue, and anemia. The incidence of interstitial lung disease (ILD) was low, and no ILD-related deaths were reported.
The Implications of the TROPION-Lung01 Study
The TROPION-Lung01 study showed that Dato-DXD improved PFS compared to docetaxel in patients with previously treated advanced or metastatic NSCLC. Not only do these results provide compelling evidence for the potential role of TROP2-directed antibody drug conjugates in treating lung cancer, but they also highlight the need for new treatment options for NSCLC patients who have progressed after platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor. And although the data for overall survival were not yet mature, an early trend was observed in favor of Dato-DXD versus docetaxel, which is the current standard-of-care chemotherapy.
References:
Datopotamab deruxtecan improved progression-free survival vs chemotherapy in patients with previously treated non-small cell lung cancer in TROPION-Lung01 Phase III trial. AstraZeneca. October 23, 2023. Accessed November 10, 2023. https://www.astrazeneca.com/media-centre/press-releases/2023/datopotamab-deruxtecan-improved-progression-free-survival-vs-chemotherapy-in-tropion-lung01-phase-iii-trial.html.
Sava J. Tropion-Lung01 trial of Datopotamab Deruxtecan meets Pfs End Point in NSCLC. Targeted Oncology. July 10, 2023. Accessed November 10, 2023. https://www.targetedonc.com/view/tropion-lung01-trial-of-datopotamab-deruxtecan-meets-pfs-end-point-in-nsclc.
Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01). ClinicalTrials.gov. October 12, 2023. Accessed November 10, 2023. https://clinicaltrials.gov/ct2/show/NCT04656652.
Yoh K, Goto Y, Thomas M, et al. A randomized, phase 3 study of datopotamab deruxtecan (Dato-DXD; DS-1062) versus docetaxel in previously treated advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations (TROPION-Lung01). Journal of Clinical Oncology. May 28, 2021. Accessed November 10, 2023. https://ascopubs.org/doi/10.1200/JCO.2021.39.15_suppl.TPS9127.
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