AstraZeneca has said its proprietary computational pathology platform-based TROP2 biomarker for datopotamab deruxtecan (Dato-DXd) predicted clinical outcomes in patients with advanced or metastatic non-small cell lung cancer (NSCLC) in TROPION-Lung01 Phase 3 trial.
The results were from an exploratory analysis of the TROPION-Lung01 trial that assessed TROP2 using AstraZeneca’s pathology platform, quantitative continuous scoring (QCS).
QCS is a fully supervised computational pathology platform. It analyses digitised images of patient tissue samples to precisely quantify targets, such as TROP2, on and within the tumour cells.
Datopotamab deruxtecan is a TROP2-targeted DXd antibody-drug conjugate (ADC) that was discovered by Daiichi Sankyo and is being jointly developed by AstraZeneca and Daiichi Sankyo.
Daiichi Sankyo R&D global head Ken Takeshita said: “The results from the QCS analysis support the potential of TROP2, as measured by quantitative continuous scoring, as a predictive biomarker for datopotamab deruxtecan and begin to answer the question of why certain patients with non-small cell lung cancer respond better to treatment.”
In this analysis, QCS was utilised to examine tissue samples from patients in the TROPION-Lung01 trial.
The analysis revealed that a higher proportion of patients with non-squamous NSCLC were TROP2-QCS biomarker positive compared to those with squamous NSCLC.
In patients with TROP2-QCS biomarker positive tumours, datopotamab deruxtecan showed significantly greater efficacy compared to docetaxel.
Dato-DXd also demonstrated a meaningfully superior magnitude of progression-free survival (PFS) benefit in patients with this biomarker.
In addition, datopotamab deruxtecan surpassed the efficacy observed in the overall trial population.
AstraZeneca oncology R&D executive vice president Susan Galbraith said: “This analysis demonstrates the power of our computational pathology platform to discover new predictive biomarkers and substantially improve patient selection for datopotamab deruxtecan.
“It also has great potential to help more precisely select patients across our broader antibody drug conjugate portfolio.”
Concurrently, AstraZeneca and Roche Tissue Diagnostics are expanding their collaboration to co-develop a new companion diagnostic.
This diagnostic will integrate AstraZeneca’s proprietary computational pathology platform, QCS, with Roche’s navify Digital Pathology image management system.
This diagnostic will assist pathologists in interpreting the investigational VENTANA TROP2 assay.
