FDA Sets Date for First-in-Class Lung Cancer Therapy


If approved, datopotamab deruxtecan would be the first TROP2-directed antibody drug conjugate to treat patients with non-small cell lung cancer. The FDA’s action date is in the fourth quarter of 2024.

The FDA has accepted the biological license application of datopotamab deruxtecan (Dato-DXd) to treat adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy. The Prescription Drug User Fee Act action date is during the fourth quarter of 2024.

This year, there will be about 234,580 new cases of lung cancer and about 125,070 deaths from lung cancer, according to the American Cancer Society. Non-small cell lung cancer is the most common type of lung cancer.

Datopotamab deruxtecan is a TROP2-directed antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo. TROP2 is a protein that is expressed in the majority of non-small cell lung cancer tumors. There is currently no TROP2-directed antibody drug conjugate approved for the treatment of lung cancer.

The BLA is based on results from the pivotal TROPION-Lung01 phase 3 trial in which datopotamab deruxtecan reduced the risk of disease progression or death by 25% in overall population and by 37% in patients with non-squamous tumor.Datopotamab deruxtecan had demonstated improvement in progression-free survival (PFS) compared with docetaxel, the current standard of care, in patients with locally advanced or metastatic non-small cell lung cancer treated with at least one prior line of therapy.

For overall survival (OS), interim results favored datopotamab deruxtecan over docetaxel in the overall population; however, results did not reach statistical significance at the time of data cut-off. The trial is ongoing and overall survival will be assessed at final analysis.

Grade 3 or higher treatment-related adverse events occurred in 25% and 41% of patients in the datopotamab deruxtecan and docetaxel arms, respectively and included neutropenia, stomatitis, anemia, asthenia, nausea and fatigue.

Results from TROPION-Lung01 were presented at the 2023 European Society for Medical Oncology Congress in October 2023.

Aaron Lisberg, M.D.

Aaron Lisberg, M.D.

“For patients with advanced non-small cell lung cancer, current standard of care second-line docetaxel is associated with limited benefit and substantial toxicity,” Aaron Lisberg, M.D., UCLA Health, Thoracic Medical Oncology and investigator in the trial, said in October. “The improvement in progression-free survival observed with datopotamab deruxtecan, particularly in patients with non-squamous tumors, and the improved tolerability of this antibody drug conjugate compared to docetaxel, represent a meaningful advance for patients with lung cancer.”

An BLA application for datopotamab deruxtecan to treat adult patients with metastatic hormone receptor-positive, HER2-negative breast cancer. In the phase 3 program in patients with breast cancer, datopotamab deruxtecan reduced the risk of disease progression or death by 37%, providing a two-month median progression-free survival benefit, and was well tolerated in post-endocrine therapy setting. These data were also presented at ESMO October 2023.

Datopotamab deruxtecan is also being studied in combination with the AstraZeneca drug Imfinzi (durvalumab) as a first-line therapy to treat patients with metastatic triple-negative breast cancer. Two phase 3 trial are ongoing.

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