Datopotamab deruxtecan (Dato-DXd) is an investigational antibody-drug conjugate (ADC) targeting TROP2, developed using Daiichi Sankyo’s exclusive DXd ADC technology. It is one of the forefront ADCs within Daiichi Sankyo’s oncology pipeline. The comprehensive analysis involved 604 patients in the full analysis set (FAS), with 43.1% having received a minimum of two prior lines of systemic therapy. At the data cutoff on 29 March 2023, around 18% of patients in the Dato-DXd arm and 6% in the docetaxel arm remained on study treatment. The confirmed overall response rates (ORRs) were 26.4% for Dato-DXd, and 12.8% for docetaxel (DTX,) with respective median duration of response (mDoR) of 7.1 and 5.6 months. Dato-DXd exhibited a noteworthy enhancement in PFS with 4.4 months for Dato-DXd and 3.7 months for DTX arm. The interim OS findings favor Dato-DXd, and the trial is continuing to the final analysis. In terms of safety analysis, the median treatment durations for Dato-DXd and docetaxel were 4.2 and 2.8 months, respectively. Stomatitis (47%; Grade ≥3, 6%) and nausea (34%; Grade ≥3, 2%) were the most frequent TRAEs seen with Dato-DXd and were predominantly grade 1 or 2. Apart from that, no new safety signals were observed with Dato-DXd, and grade ≥3 ILD was seen, highlighting the need for careful monitoring and adherence to ILD management guidelines.

Conclusion

Dato-DXd stands as the pioneering ADC to exhibit a statistically significant enhancement in progression-free survival (PFS) compared to docetaxel among patients with previously treated, locally advanced, or metastatic NSCLC. These compelling results position Dato-DXd as a prospective and meaningful therapeutic option for individuals with previously treated non-squamous NSCLC.

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