The therapy datopotamab deruxtecan did not meet its secondary dual primary end point of overall survival for patients with advanced non-small cell lung cancer but it did show a trend of improvement in overall survival compared with docetaxel for patients in the non squamous subgroup.
SAN DIEGO, Sept. 10, 2024 /PRNewswire-PRWeb/ -- Datopotamab Deruxtecan Does Not Meet Its Secondary Primary Endpoint in TROPION-Lung01, But Researchers Believe Therapy is Still Beneficial for Some Patients with Non Squamous NSCLC.
The therapy datopotamab deruxtecan did not meet its secondary dual primary end point of overall survival for patients with advanced non-small cell lung cancer but it did show a trend of improvement in overall survival compared with docetaxel for patients in the non squamous subgroup.
The data was presented today by Dr. Jacob Sands, Dana-Farber Cancer Institute in Boston, Mass., at the International Association for the Study of Lung Cancer 2024 World Conference on Lung Cancer.
Patients with advanced non-small cell lung cancer have limited treatment options after lung cancer progresses on first-line therapies. Datopotamab deruxtecan (Dato-DXd) is a novel trophoblast cell surface antigen 2-directed antibody-drug conjugate under clinical evaluation in multiple solid tumor types.
The pivotal TROPION-Lung01 trial in patients with previously treated advanced NSCLC had met its dual primary endpoint of improved progression-free survival versus docetaxel (hazard ratio [HR] 0.75; 95% CI, 0.62-0.91; P=0.004). Superior efficacy outcomes were observed with Dato-DXd in patients with non squamous lung cancer.
"Dato-DXd did not meet its overall survival endpoint, but the therapy has many positive upsides that make it an option for some patients with non-squamous NSCLC," said Dr. Sands pointing out the multiple improved outcomes in the non-squamous group for Dato-DXd vs docetaxel including response rate (31.2% vs 12.8%), median PFS (5.5 vs 3.6 months), and a trend of improvement in OS (14.6 vs 12.3 months).
Dr. Sands reported baseline characteristics were balanced between arms, and median follow-up was 23.1 months for both treatment arms. Median overall survival was 12.9 months (95% CI, 11.0-13.9) with Dato-DXd versus 11.8 months (95% CI, 10.1- 12.8) with docetaxel (HR 0.94; 95% CI, 0.78-1.14; P =0.530) in the full analysis set.
However, Dr. Sands said that median overall survival was numerically longer in the prespecified nonsquamous subgroup with 14.6 months (95% CI, 12.4-16.0) with Dato-DXd vs 12.3 months (95% CI, 10.7-14.0) with docetaxel( HR 0.84; 95% CI, 0.68-1.05).
"The overall safety and efficacy profile of Dato-DXd supports its use as a potential new therapeutic option for patients with nonsquamous NSCLC who are eligible for subsequent therapy," said Dr. Sands.
About the IASLC:
The International Association for the Study of Lung Cancer (IASLC) is the only global organization dedicated solely to the study of lung cancer and other thoracic malignancies. Founded in 1974, the association's membership includes more than 10,000 lung cancer specialists across all disciplines in over 100 countries, forming a global network working together to conquer lung and thoracic cancers worldwide. The association also publishes the Journal of Thoracic Oncology, the primary educational and informational publication for topics relevant to the prevention, detection, diagnosis, and treatment of all thoracic malignancies. Visit http://www.iaslc.org for more information.
About the WCLC:
The World Conference on Lung Cancer (WCLC) is the world's largest meeting dedicated to lung cancer and other thoracic malignancies, attracting nearly 7,000 researchers, physicians and specialists from more than 100 countries. The goal is to increase awareness, collaboration and understanding of lung cancer, and to help participants implement the latest developments across the globe. The conference will cover a wide range of disciplines and unveil several research studies and clinical trial results. For more information, visit https://wclc2024.iaslc.org.
Media Contact
Chris Martin, IASLC, 6306702745, [email protected], www.iaslc.org
SOURCE IASLC
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