FDA Grants Breakthrough Therapy Designation to Datopotamab Deruxtecan for Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer

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The FDA has granted Breakthrough Therapy Designation (BTD) to AstraZeneca’s and Daiichi Sankyo’s datopotamab deruxtecan (Dato-DXd) for adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose disease progressed following treatment with an EGFR-tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy. According to the company, the BTD was based on results from the TROPION-Lung05 Phase II trial, with supporting data coming from the TROPION-Lung01 Phase II clinical trial, both in Dato-DXd.¹

“This Breakthrough Therapy Designation reinforces datopotamab deruxtecan as a promising potential therapy for patients with EGFR-mutated lung cancer who continue to face significant unmet needs following disease progression on or after initial treatments. We are proud to have long supported patients with EGFR-mutated lung cancer and look forward to the possibility of bringing another innovative treatment option to this community,” said Susan Galbraith, EVP, oncology R&D, AstraZeneca, in a press release.

The global, multicenter, single-arm, open-label TROPION-Lung05 trial evaluated the efficacy and safety of Dato-DXd in patients with locally advanced or metastatic NSCLC with actionable genomic alterations who have progressed on at least one TKI. Consisting of 137 patients across Asia, Europe, and North America, the primary endpoint of the trial was objective response rate as assessed by blinded independent central review, with secondary endpoints including duration of response, disease control rate, clinical benefit rate, progression-free survival (PFS), time to response, overall survival (OS), and safety.

The global, randomized, multicenter, open-label TROPION-Lung01 trial evaluated the efficacy and safety of Dato-DXd versus docetaxel in adult patients with locally advanced or metastatic NSCLC with and without actionable genomic alterations who require systemic therapy following prior treatment. Additionally, patients with actionable genomic alterations were previously treated with an approved targeted therapy and platinum-based chemotherapy. Consisting of an estimated 600 patients, primary PFS results and interim OS results from TROPION-Lung01 were presented at the ESMO 2023 Congress.¹

According to the American Cancer Society, NSCLC accounts for 80% to 85% of all lung cancers. It is estimated that by the end of the year, there will be around 234,580 new cases of lung cancer in the United States, with 125,070 deaths expected. While lung cancer is mainly diagnosed in patients over 65 years of age, it can also occur in patients younger than 45 years of age, with a median diagnosis age of 70 years old.

Lung cancer is considered to be the leading cause of cancer deaths in the United States, accounting for one out of every five cancer deaths annually. Additionally, more people die of lung cancer annually than colon, breast, and prostate cancers combined. In men, the lifetime chance of getting lung cancer is one in sixteen, while women have a one in seventeen chance. Additionally, black men are an estimated 12% more likely to get it than white men. However, black women have a 16% lower chance of getting it than white women.²

“The Breakthrough Therapy Designation granted by the FDA underscores the significant unmet need for new treatments for patients with previously treated EGFR-mutated non-small cell lung cancer who have experienced disease progression. Datopotamab deruxtecan has the potential to play an important role in improving outcomes and we look forward to working closely with the FDA to bring this medicine to patients as quickly as possible.”

References

1. Datopotamab deruxtecan granted breakthrough therapy designation in US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer. AstraZeneca. December 9, 2024. Accessed December 9, 2024. https://www.astrazeneca.com/media-centre/press-releases/2024/datopotamab-deruxtecan-granted-breakthrough-therapy-designation-us-patients-previously-treated-advanced-egfr-mutated-non-small-cell-lung-cancer.html#!

2. Key Statistics for Lung Cancer. American Cancer Society. Accessed December 9, 2024. https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html