AstraZeneca and Daiichi Sankyo recently announced that the TROPION-Lung01 Phase III trial, which looked at the effectiveness of datopotamab deruxtecan in previously treated patients with advanced or metastatic non-small cell lung cancer (NSCLC), showed a statistically significant improvement in progression-free survival (PFS) compared to the standard treatment, docetaxel. This development represents a huge step forward in the treatment of NSCLC, a disease that has been a problem for oncologists globally for a considerable amount of time. 

The trial achieved one of its key endpoints, PFS, and the preliminary data indicated a positive tendency towards overall survival (OS), demonstrating that datopotamab deruxtecan has the potential to be an effective therapy choice for NSCLC. Datopotamab deruxtecan’s safety profile was consistent with that of earlier trials, which further strengthens the potential for the drug’s application in clinical settings. Participants in the trial came from all over the world and had stage IIIB, IIIC, or IV NSCLC. They either had or did not have actionable genetic changes, and they had received at least one prior treatment. The patients were randomised to receive intravenous infusions of either 6.0mg/kg of datopotamab deruxtecan or 75mg/m² of docetaxel every three weeks. 

Datopotamab deruxtecan is an antibody-drug conjugate (ADC) that targets the protein TROP2, which is overexpressed in numerous malignancies, including NSCLC. The ADC technology enables the delivery of cytotoxic agents to cancer cells while minimising injury to healthy cells. This targeted approach will revolutionise the treatment of NSCLC by providing an alternative that is more effective and less toxic than traditional chemotherapy. 

According to GlobalData’s Consensus Analyst Forecast, global sales for datopotamab deruxtecan are expected to reach $2.5bn by 2029, driven by expansion into new indications, including HER2-negative breast, triple-negative breast, and ovarian cancer. GlobalData predicts that AstraZeneca/Daiichi Sankyo’s datopotamab deruxtecan will lead the market, as its competitor, Gilead Sciences’s Trodelvy (sacituzumab govitecan) is nine months behind Daiichi Sankyo’s TROPION-Lung01 trial for NSCLC. Another TROP2 targeted therapy, SKB-264, developed by Merck and KLUS Pharma, is in Phase II clinical trials globally and in Phase III trials in China for multiple cancer indications. However, the positive data from TROPION-Lung01 shows the potential for datopotamab deruxtecan to become the first tumour-agnostic therapeutic, targeting any TROP2-expressing cancer. This will boost sales for the ADC and provide an effective therapeutic option for patients with minimal treatment choices. The introduction of datopotamab deruxtecan may position AstraZeneca and Daiichi Sankyo as market leaders in the previously treated NSCLC niche.