AstraZeneca and Daiichi Sankyo have achieved significant progress in the fight against non-small cell lung cancer (NSCLC). Their jointly developed antibody-drug conjugate (ADC), datopotamab deruxtecan (Dato-DXd), has demonstrated a groundbreaking 25% reduction in the risk of disease progression or death when compared to the current standard of care, docetaxel, in patients with locally advanced or metastatic NSCLC who have undergone at least one prior line of therapy. This pivotal TROPION-Lung01 Phase III trial outcome marks a milestone in the field of oncology, offering new hope to patients with limited treatment options.
Datopotamab deruxtecan was especially effective in patients with non-squamous NSCLC, with a remarkable 37% risk reduction for disease progression or death compared to docetaxel. In this subgroup, the median progression-free survival (PFS) extended to 5.6 months with datopotamab deruxtecan, while docetaxel only provided 3.7 months of PFS. Furthermore, a confirmed objective response rate (ORR) of 31.2% was achieved with datopotamab deruxtecan, including four complete responses (CRs), whereas docetaxel yielded an ORR of only 12.8% with no CRs observed. However, the treatment did not show a PFS benefit in patients with squamous NSCLC.
While interim results indicate a favorable trend in overall survival (OS), these findings have yet to reach statistical significance. The TROPION-Lung01 trial is ongoing, and OS will be assessed in a final analysis.
Dr. Aaron Lisberg of UCLA Health, who participated in the trial, emphasized the importance of this advancement, particularly for patients with non-squamous tumors, where the current standard of care, docetaxel, offers limited benefits but comes with significant toxicity.
Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, highlighted the potential of ADC technology to replace established standards of care like chemotherapy in various cancer types. Datopotamab deruxtecan’s achievement in extending disease progression-free survival beyond conventional chemotherapy is especially noteworthy, considering its lower incidence of treatment-related severe adverse events.
Ken Takeshita, MD, Global Head of R&D at Daiichi Sankyo, expressed optimism about the broad application of DXd ADC technology across different cancer targets and types, especially for patients with limited treatment options following initial therapy.
In terms of safety, datopotamab deruxtecan demonstrated a favorable profile, with fewer severe adverse events compared to docetaxel. Notably, there were no new safety concerns identified.
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