AstraZeneca and Daiichi Sankyo have collaboratively submitted a new Biologics License Application (BLA) for accelerated approval in the United States for datopotamab deruxtecan (Dato-DXd). This application aims to provide treatment for adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFR) non-small cell lung cancer (NSCLC) who have previously undergone systemic therapies, including EGFR-directed therapy.

The companies have chosen to voluntarily withdraw the previously submitted BLA in the US for datopotamab deruxtecan for patients with advanced or metastatic nonsquamous NSCLC. This decision was based on the results of the TROPION-Lung01 Phase III trial. Following feedback from the US Food and Drug Administration (FDA), the companies have opted to submit a new BLA specifically for EGFR-mutated NSCLC, while withdrawing the previous application for nonsquamous NSCLC.

In 2022, nearly 2.5 million cases of lung cancer were diagnosed globally. Lung cancer is categorized into small-cell lung cancer (SCLC) or NSCLC, with the latter accounting for approximately 80% of cases. About 10-15% of NSCLC patients in the US and Europe, and 30-40% in Asia, have an EGFR mutation. The majority of EGFR mutations are found in tumors of nonsquamous histology.

Recognizing the critical need for advancements in this field, we are examining the ongoing TROPION-Lung01 Phase III trial, which seeks to address the challenges encountered by patients with EGFR-mutated NSCLC.

Here is a brief overview of the study:

Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01)

Study Details | Source

  • Sponsor: Daiichi Sankyo
  • This study will evaluate the efficacy, safety, and pharmacokinetics of DS-1062a versus docetaxel in participants with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) with or without actionable genomic alterations.
  • Interventions:
    • Drug: DS-1062a
    • Drug: Docetaxel
  • Primary Outcomes Measures:
    • Progression-free Survival (PFS) As Assessed by Blinded Independent Central Review (BICR) Per RECIST v1.1 Following DS-1062a Versus Docetaxel
      • PFS is defined as the time from randomization to the earlier of the dates of the first documentation of radiographic progressive disease or death due to any cause.
      • From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
    • Overall Survival (OS) Following DS-1062a Versus Docetaxel
      • OS is defined as the time from randomization to the date of death due to any cause.
      • From randomization until date of death due to any cause, up to approximately 43 months

The TROPION-Lung01 study had previously met the dual primary endpoint of progression-free survival in the overall trial population. The recent submission of a BLA raises the question of potential FDA approval for this treatment. The results of this trial have the potential to significantly impact future guidelines and clinical practices in the field.

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