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AstraZeneca and Daiichi Sankyo recently announced the latest pooled data results from the Phase 2 trial TROPION-Lung05 and the Phase 3 trial TROPION-Lung01.Analysis shows that datopotamab deruxtecan (Dato-DXd), a Trop2-targeted antibody-drug conjugate (ADC) jointly developed by the two companies, has demonstrated significant clinical efficacy in previously treated patients with advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC). These data provide strong support for the recent submission of a Biologics License Application (BLA) in the United States for this patient population.

InTROPION-Lung05（n=78) andTROPION-Lung01（n=39) A total of117NameEGFRMutationNSCLCIn the pooled analysis conducted by patients,Blinded Independent Central Review (BICR) Analyzed bydatopotamab deruxtecanConfirmation of Objective Response Rate (ORR) for42.7%（95% CI：33.6%-52.2%）, andObserved complete response (CR）5Example (4.3%), Partial Response (PR）45Example (38.5%) and stable disease (SD）48Example (41.0%）。MedianDuration of Relief (DOR) for7.0Months (95% CI：4.2-9.8），Disease Control Rate (DCR) for86.3%（95% CI：78.7-92.0）。Median Progression-Free Survival (PFS) for5.8Months (95% CI：5.4-8.2), Median Overall Survival (OS) for15.6Months (95% CI：13.1-19.0）。

In patients previously treated with osimertinib, the analysis results were consistent with the overall pooled population.Among 96 patients previously treated with osimertinib, the confirmed ORR assessed by BICR was 44.8% (95% CI: 34.6-55.3%). There were 4 cases of complete response (4.2%), 39 cases of partial response (40.6%), and 37 cases of stable disease (38.5%). The median DOR was 6.9 months (95% CI: 4.2-9.8), with a DCR of 85.4% (95% CI: 76.7-91.8). The median PFS was 5.7 months (95% CI: 5.4-7.9), and the median OS was 14.7 months (95% CI: 13.0-18.3).

▲ Summary of Pooled Analysis Results from Two Trials (Image Source: Reference [1])

Datopotamab deruxtecanSafety data withTROPION-Lung05AndTROPION-Lung01Consistent with previous reports of the trial, no new safety issues were identified.

Patients included in the pooled analysis had received a median of 3 prior lines of therapy.(Range 1-5)Metastatic StageTreatment. 82% of patients had received osimertinib, with 40.2% using it in first-line treatment and 29.1% in second-line treatment. Various EGFR mutation types were observed in the pooled population, including exon 19 deletions (exon 19 del), exon 21 L858R mutations, exon 20 T790M mutations, exon 18 G719X mutations, exon 21 L861Q mutations, exon 20 insertions (exon 20 ins), and exon 20 C797S mutations.

Datopotamab deruxtecan is a Trop2-targeted ADC. Designed using Daiichi Sankyo's proprietary DXd ADC technology.Datopotamab deruxtecan is generated by conjugating a humanized anti-Trop2 monoclonal antibody with multiple topoisomerase I inhibitor payloads (DXd) through a cleavable tetrapeptide linker.

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References:

[1] Datopotamab Deruxtecan Demonstrated Meaningful Clinical Activity in Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer in TROPION-Lung05 and TROPION-Lung01 Pooled Analysis. Retrieved December 6, 2024 from https://www.businesswire.com/news/home/20241205215995/en/Datopotamab-Deruxtecan-Demonstrated-Meaningful-Clinical-Activity-in-Patients-with-Previously-Treated-Advanced-EGFR-Mutated-Non-Small-Cell-Lung-Cancer-in-TROPION-Lung05-and-TROPION-Lung01-Pooled-Analysis

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