DAIICHI SANKYO, INC.

I-DXd (ifinatamab deruxtecan) showed clinically meaningful responses in pretreated extensive-stage SCLC patients, with a confirmed response rate of 26.1% at 8 mg/kg and 54.8% at 12 mg/kg. The 12 mg/kg dose was selected as optimal for further study.

AstraZeneca and Daiichi Sankyo unveiled an AI-powered TROP2-QCS biomarker predicting clinical outcomes in NSCLC patients treated with datopotamab deruxtecan. In TROPION-Lung01 Phase III study, TROP2-QCS-positive patients showed a 43% reduction in disease progression or death risk with Dato-DXd vs. docetaxel, compared to 25% in the overall study population. TROP2-QCS, developed via AstraZeneca’s QCS platform, assesses TROP2 membrane expression relative to cytoplasm, classifying patients as TROP2-QCS-positive if 75% of tumor cells have an NMR below a specified value.

TROPION-Lung01 Phase III trial results show datopotamab deruxtecan (6.0mg/kg) had a median OS of 12.9 months vs. 11.8 months for docetaxel (75mg/m²) in advanced NSCLC patients. The HR was 0.94 (95% CI 0.78-1.14), with a p-value of 0.530. In nonsquamous histology, datopotamab deruxtecan showed a median OS of 14.6 months vs. 12.3 months for docetaxel, with an HR of 0.84 (95% CI 0.68-1.05). Patients with actionable genomic alterations saw a median OS of 15.6 months with datopotamab deruxtecan vs. 9.8 months with docetaxel, HR 0.65 (95% CI 0.40-1.08). NeoCOAST-2 trial showed datopotamab deruxtecan plus Imfinzi and carboplatin had a pCR rate of 34.1% and mPR rate of 65.9% in early-stage resectable NSCLC.

MSD and Daiichi Sankyo presented interim results from the Ideate-Lung01 trial at WCLC, showing the 12 mg/kg dose of ifinatamab deruxtecan (I-DXd) had a 54.8% overall response rate (ORR) in extensive-stage small cell lung cancer (SCLC) patients, with a disease control rate (DCR) of 90.5%. The higher dose also showed improved progression-free and overall survival. Safety concerns included interstitial lung disease and gastrointestinal toxicities, but no 'great surprises'. The companies have started phase 3 Ideate-Lung02 study.

Merck & Daiichi Sankyo's ifinatamab deruxtecan showed a 54.8% objective response rate in pretreated ES-SCLC patients, selected as optimal dose for ongoing trials.

TROP2 biomarker, measured by AstraZeneca's QCS, predicts clinical outcomes in NSCLC patients treated with datopotamab deruxtecan in TROPION-Lung01 trial, showing greater efficacy in TROP2-QCS positive tumors. AstraZeneca and Roche collaborate to develop a TROP2-QCS companion diagnostic.

AstraZeneca and Daiichi Sankyo's datopotamab deruxtecan showed greater progression-free survival benefit in TROP2-QCS biomarker positive NSCLC patients, prompting collaboration with Roche Tissue Diagnostics to co-develop a TROP2-QCS biomarker companion diagnostic.

AstraZeneca and Roche Tissue Diagnostics collaborate to co-develop a TROP2-QCS biomarker companion diagnostic, aiming to improve patient care in advanced non-small cell lung cancer (NSCLC) treatment. The partnership leverages AstraZeneca’s QCS computational pathology platform within Roche’s navify® Digital Pathology system, focusing on TROPION-Lung01 trial evaluating datopotamab deruxtecan efficacy in NSCLC.