FDA Accepts BLA for Datopotamab Deruxtecan for the Treatment of NSCLC


Datopotamab deruxtecan is an investigational TROP2 directed antibody drug conjugate that showed positive survival impact compared to chemotherapy.

The FDA accepted a biologics license application (BLA) for datopotamab deruxtecan (Dato-DXd; AstraZeneca and Daiichi Sankyo) for the treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) in adult patients who have received prior systemic therapy.

Image credit: utah51 | stock.adobe.com

Image credit: utah51 | stock.adobe.com

The submission is based on positive survival outcomes observed in the TROPION-Lung01 phase 3 study; when compared to standard of care (docetaxel), datopotamab deruxtecan significantly prolonged progression-free survival (PFS) in previously treated patients.

“We are encouraged by the FDA's acceptance of the BLA as we endeavor to make datopotamab deruxtecan the first TROP2 directed antibody drug conjugate approved to treat patients with nonsquamous [NSCLC] after disease progression on prior systemic therapy,” said Ken Takeshita, MD, the global head of R&D at Daiichi Sankyo, in the press release.

Investigators evaluated duel-primary endpoints of PFS, as assessed by blinded independent central review, and overall survival (OS). Datopotamab deruxtecan led to a clinically meaningfulPFS compared to standard of care chemotherapy and led to favorable OS (although this was not statistically significant).

The drug also shares a consistent safety profile with what was determined in previous trials.Investigators will continue to evaluate this key secondary endpoint, along with others including investigator-assessed PFS, objective response rate, duration of response, time to response, BICR and investigator-evaluated disease control rate.

Datopotamab deruxtecan is an investigational TROP2 directed antibody drug conjugate (ADC) that is being developed by Daiichi Sankyo and AstraZeneca. The therapeutic includes a humanized anti-TROP2 IgG1 monoclonal antibody that targets protein TROP2, which is largely expressed in many NSCLC tumors.

Investigators conducted TROPION-Lung01 phase 3 study to evaluate the safety and efficacy of datopotamab deruxtecan compared with standard of care chemotherapy (docetaxel) for patients previously treated with systematic therapy for locally advanced or metastatic NSCLC in the phase 3 and open-label TROPION-Lung01 study.

The cohort included 600 patients across 4 continents who have been randomized to receive datopotamab deruxtecan or docetaxel. Some patients have actionable genomic alterations and previously received platinum-based chemotherapy and an approved targeted therapy, while others have no actionable genomic alterations, and had previously received platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor.

Approximately 80% of lung cancer cases are NSCLC, and 70% of NSCLC tumors are nonsquamous. Unfortunately, most patients experience disease progression following first-line immunotherapy or targeted therapy, which leaves chemotherapy as the last best option to treat locally advanced disease.

The TROPION-Lung01 study is part of a comprehensive development program called TROPION, which is evaluating datopotamab deruxtecan for various cancers. The results from other phase 3 studies in TROPION (eg, the TROPION-Breast01 study) were also significant, so the companies have submitted a parallel BLA for datopotamab deruxtecan for the treatment of adult patients with metastatic hormone receptor positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer.

“Today’s news is an important step forward in our goal of creating new standards of care that have the potential to transform the treatment of patients with [NSCLC],” Takeshita said in the press release.

“This is only the beginning of our efforts to make this novel treatment available to patients as quickly as possible,” said Susan Galbraith, MBBChir, PhD, executive vice president of Oncology R&D at AstraZeneca, in the press release.


Datopotamab Deruxtecan Biologics License Application Accepted in the U.S. for Patients with Previously Treated Advanced Nonsquamous Non-Small Cell Lung Cancer. Daiichi Sankyo. News Release. February 19, 2024. Accessed on February 20, 2024. https://www.daiichisankyo.com/files/news/pressrelease/pdf/202402/20240219_E.pdf

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