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AstraZeneca/Daiichi Make Their Case For Dato-DXd In Non-Squamous Lung Cancer

Early-Stage PD-L1/Chemo Combo Data Also Reported

 
• By Mandy Jackson

Data at WCLC showed why the TROP2-targeting ADC datopotamab deruxtecan is most effective in non-squamous NSCLC in second or later lines as presented in overall survival data at the meeting.

Futuristic medical concept with blue human lungs
AstraZeneca used a proprietary AI-based model to analyze TROP2 expression • Source: Shutterstock

AstraZeneca PLC and Daiichi Sankyo Co., Ltd. presented data on 8 and 9 September that seem to support their decision to seek US Food and Drug Administration approval for their TROP2-targeting antibody-drug conjugate (ADC) datopotamab deruxtecan (Dato-DXd) as a second-line or later treatment for non-small cell lung cancer (NSCLC), but only in patients with non-squamous histology. The FDA is expected to make its approval decision by 20 December.

Key Takeaways

  • AstraZeneca and Daiichi Sankyo anticipate a US FDA approval decision later this year for their TROP2 ADC Dato-DXd in second-line treatment of non-squamous NSCLC, reflecting a subpopulation of the Phase III TROPION-Lung01 study in which overall survival was higher than in the broader group.

  • Novel biomarker data presented at the WCLC meeting suggest that TROP2 expression is higher in non-squamous NSCLC, providing an explanation for the difference in efficacy

The drug makers reported TROP2 biomarker prevalence, per quantitative continuous scoring (QCS) in NSCLC patients enrolled in the Phase III TROPION-Lung01 clinical trial of Dato-DXd versus docetaxel, at the International Association for the Study of Lung Cancer’s World Conference on Lung

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