AstraZeneca and Daiichi Sankyo have announced positive results from a pooled analysis of two clinical trials evaluating datopotamab deruxtecan (dato-dxd) in patients with EGFR-mutated non-small cell lung cancer (NSCLC). The data supports their revised plans for accelerated approval of the cancer drug.
The analysis, which combined data from the TROPION-Lung05 and TROPION-Lung01 trials, showed that dato-dxd kept tumors in check for a median of approximately six months in patients whose NSCLC was driven by mutations in the epidermal growth factor receptor (EGFR) gene. Among the 117 patients included in the analysis, the median overall survival was 15.6 months.
These findings have underpinned an accelerated approval filing submitted last month for EGFR-mutated lung cancer, representing a more focused application compared to their initial expectations. The accelerated approval pathway allows for earlier approval of drugs that fill an unmet medical need for a serious condition, based on a surrogate endpoint that is reasonably likely to predict clinical benefit. Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Clinical Efficacy and Safety
The pooled analysis provides a more comprehensive understanding of the efficacy and safety profile of datopotamab deruxtecan in this specific patient population. While detailed data from the trials were not included in the press release, the reported median progression-free survival and overall survival figures suggest a clinically meaningful benefit for patients with EGFR-mutated NSCLC who have previously been treated.
Current Treatment Landscape
EGFR-mutated NSCLC represents a significant subset of lung cancer cases, and while targeted therapies have improved outcomes, resistance to these treatments often develops. Datopotamab deruxtecan, an antibody-drug conjugate (ADC), offers a novel approach by delivering a cytotoxic payload directly to cancer cells expressing the TROP2 protein. This mechanism of action may overcome resistance mechanisms seen with traditional EGFR inhibitors.
Other Notable Developments
In related news, the FDA granted accelerated approval to Merus’ drug zenocutuzumab for adult patients with unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC) or pancreatic cancer whose tumors have NRG1 fusion. The clearance is the FDA’s first of a systemic therapy for these specific tumors. Merus recently agreed to license U.S. rights to the drug, which will be sold as Bizengri, to Partner Therapeutics for an undisclosed sum. Bizengri is Merus’ first approved product.
