Pharma Focus Asia

Datopotamab Deruxtecan Demonstrates Clinically Significant Increase in Overall Survival Compared to Chemotherapy for Advanced Nonsquamous Non-Small Cell Lung Cancer

Tuesday, May 28, 2024

In the TROPION-Lung01 phase 3 trial, datopotamab deruxtecan (Dato-DXd) demonstrated promising overall survival (OS) trends compared to docetaxel in adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who had undergone at least one prior line of therapy. Although the OS results did not achieve statistical significance in the overall trial population, there was a notable improvement in OS observed specifically in patients with nonsquamous NSCLC, a subgroup where Dato-DXd exhibited clinically meaningful benefits over the current standard of care, docetaxel.

Developed collaboratively by Daiichi Sankyo and AstraZeneca, Dato-DXd is an engineered antibody drug conjugate targeting TROP2, a protein commonly found in NSCLC tumors. The drug showed statistically significant improvements in progression-free survival (PFS) and meaningful clinical benefits in nonsquamous NSCLC patients during earlier analyses. Safety-wise, Dato-DXd maintained a consistent profile with previous assessments, with fewer dose adjustments or discontinuations due to adverse events compared to docetaxel and no new safety concerns identified.

Dr. Ken Takeshita from Daiichi Sankyo emphasized the potential of Dato-DXd as a significant advancement in treating nonsquamous NSCLC, highlighting its notable improvements in OS, PFS, overall response rates, and duration of response compared to conventional chemotherapy. He expressed intentions to expedite regulatory discussions to make Dato-DXd available to patients. Similarly, Dr. Susan Galbraith from AstraZeneca underscored the significance of Dato-DXd's survival benefits, particularly in a treatment landscape where conventional options have been largely unchanged for some time.

These findings will be presented at upcoming medical conferences and will support regulatory submissions worldwide, including in the US and EU, for the treatment of adult patients with locally advanced or metastatic nonsquamous NSCLC who have received prior systemic therapy.

TROPION-Lung01, a global phase 3 trial, enrolled approximately 600 patients across various regions. The trial's primary endpoints were PFS and OS, with key secondary endpoints including objective response rate, duration of response, and safety assessments.

With nearly 2.5 million new cases of lung cancer diagnosed globally each year, NSCLC remains a significant health challenge. While advancements in immunotherapy and targeted therapies have improved outcomes in earlier lines of treatment, there remains a need for effective therapies for patients who progress after initial treatments. Dato-DXd represents a promising candidate in this regard, with its potential to offer meaningful clinical benefits to patients with advanced nonsquamous NSCLC.



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