On Monday, AstraZeneca Plc (NASDAQ: AZN) revealed detailed results from its Phase 3 TROPION-Lung01 trial comparing datopotamab deruxtecan (Dato-DXd) to docetaxel, the standard chemotherapy for patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who had received at least one prior treatment.
The trial showed a promising trend in favor of datopotamab deruxtecan regarding overall survival (OS) compared to docetaxel, though the results did not reach statistical significance. In the overall trial population, OS for Dato-DXd was 12.9 months compared to 11.8 months for docetaxel, with a hazard ratio of 0.94 (p=0.530). However, in a subgroup of patients with nonsquamous NSCLC, Dato-DXd demonstrated a 2.3-month improvement in OS, extending survival to 14.6 months versus 12.3 months for those treated with docetaxel.
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Dato-DXd is an engineered TROP2-directed antibody-drug conjugate discovered by Daiichi Sankyo Ltd. (OTC: DSKYF) and is being co-developed by AstraZeneca and Daiichi Sankyo. The safety profile of Dato-DXd was consistent with previous analyses, showing lower rates of dose reduction and discontinuation due to adverse events compared to docetaxel.
In addition to the TROPION-Lung01 trial, AstraZeneca presented results from its NeoCOAST-2 Phase 2 platform trial at the World Conference on Lung Cancer (WCLC). This trial examined combinations of Imfinzi (durvalumab) with other treatments, including Dato-DXd, in patients with early-stage resectable NSCLC. Early findings showed a pathological complete response rate of 34.1% and a major pathological response rate of 65.9% in patients receiving neoadjuvant Imfinzi with Dato-DXd and carboplatin.
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AstraZeneca has also made recent strides with Imfinzi. The FDA recently approved the drug in combination with chemotherapy for adult patients with early-stage resectable NSCLC, provided they have no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements.
Despite these promising developments, AstraZeneca’s stock saw a slight dip, with shares down 1.16% to $79.95 during Tuesday’s premarket session.
Key Points:
i. AstraZeneca’s Phase 3 TROPION-Lung01 trial showed that datopotamab deruxtecan (Dato-DXd) demonstrated a trend toward improved overall survival compared to standard chemotherapy (docetaxel) in advanced nonsquamous non-small cell lung cancer patients.
ii. Dato-DXd extended overall survival to 14.6 months in a subgroup of patients with nonsquamous NSCLC, compared to 12.3 months for docetaxel.
iii. The safety profile of Dato-DXd was favorable, with lower rates of adverse event-related dose reductions and discontinuations compared to docetaxel.
iv. At the World Conference on Lung Cancer, AstraZeneca presented positive results from the NeoCOAST-2 Phase 2 trial, which showed a 34.1% pathological complete response rate in early-stage NSCLC patients treated with Imfinzi, Dato-DXd, and carboplatin.
v. The FDA recently approved AstraZeneca’s Imfinzi in combination with chemotherapy for resectable early-stage NSCLC, bolstering the company’s lung cancer treatment portfolio.
Susan Guglielmo – Reprinted with permission of Whatfinger News
