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AstraZeneca and Daiichi Sankyo Refocus On New BLA Filed for Lung Cancer Drug Targeting EGFR-Mutated NSCLC

AstraZeneca and Daiichi Sankyo seek accelerated FDA approval for datopotamab deruxtecan in EGFR-mutated NSCLC.

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  • Nov 13, 2024

  • Simantini Singh Deo

AstraZeneca and Daiichi Sankyo Refocus On New BLA Filed for Lung Cancer Drug Targeting EGFR-Mutated NSCLC

AstraZeneca and Daiichi Sankyo have submitted a new Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd). They are seeking accelerated approval in the U.S. to treat adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has epidermal growth factor receptor (EGFR) mutations. The application is intended for patients who have already been treated with systemic therapies, including EGFR-targeted drugs.


In conjunction with this submission, the companies have voluntarily withdrawn an earlier BLA for datopotamab deruxtecan as a treatment for advanced or metastatic nonsquamous NSCLC. This adjustment follows the U.S. Food and Drug Administration (FDA) feedback, guiding the new focus on EGFR-mutated NSCLC.


The new BLA submission relies on data from the TROPION-Lung05 Phase II trial, alongside supporting evidence from the TROPION-Lung01 Phase III and TROPION-PanTumor01 Phase I trials. Additional findings from pooled analyses of EGFR-mutated NSCLC patients treated in the TROPION-Lung05 and TROPION-Lung01 trials will be presented at the upcoming European Society for Medical Oncology (ESMO) Asia 2024 Congress.


Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said in a statement, “TROPION-Lung01 was designed to test the potential to improve upon standard-of-care chemotherapy in a broad, previously treated, advanced lung cancer patient population. The results and data from TROPION-Lung05 showed an especially pronounced benefit for patients with an EGFR mutation. This informed our discussions with the FDA and the decision to seek accelerated approval of datopotamab deruxtecan in this patient population. TROPION-Lung01 has also provided exciting exploratory data supporting our biomarker development, which will be validated in ongoing and planned Phase III lung cancer trials.” 


Datopotamab deruxtecan, a TROP2-directed DXd antibody-drug conjugate (ADC) developed by Daiichi Sankyo, is co-developed with AstraZeneca. The companies are also assessing the drug alone and in combination with Tagrisso (osimertinib) in other ongoing Phase III trials, TROPION-Lung14 and TROPION-Lung15, targeting advanced EGFR-mutated nonsquamous NSCLC. Additionally, ongoing Phase III studies like AVANZAR and TROPION-Lung10 aim to confirm the QCS (quantitative continuous scoring) biomarker for TROP2, initially identified in TROPION-Lung01. Further research is planned for patients with biomarker-positive tumours in the second-line setting of nonsquamous NSCLC.


“Treating EGFR-mutated non-small cell lung cancer is incredibly challenging following disease progression given that the complexity and variability of these mutations often lead to resistance. The potential approval of datopotamab deruxtecan could offer renewed hope for patients with this formidable disease,” commented Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo.

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