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AstraZeneca (AZN) Down 9% on Mixed Lung Cancer Study Results

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AstraZeneca (AZN - Free Report) reported results from an interim analysis of the phase III TROPION-Lung01 study evaluating datopotamab deruxtecan (Dato-DXd) in patients with locally advanced or metastatic non-small cell lung cancer (“NSCLC”) treated with at least one prior therapy.

The company reported mixed results from the TROPION-Lung01 study. Though the TROPION-Lung01 study showed that treatment with datopotamab deruxtecan achieved one of its dual primary endpoints of progression-free survival (“PFS”) over the current standard of care chemotherapy, it did not achieve the other dual primary endpoint of overall survival (“OS”) with statistical significance.

Shares of AstraZeneca were down 8.8% on Monday post the announcement. Alhough management claimed that the OS data was still favorable and yet to mature, several Wall Street analysts pointed out that the company did not declare the positive PFS result to be “clinically meaningful”. AstraZeneca also reported that some participants in the study also experienced a Grade 5 (fatal) serious adverse event though it is unclear whether the event occurred because of the drug’s intake. Per an article by the National Library of Medicine, a grade 5 SAE indicates the worst outcome, i.e., death. The company’s press release lacked any numerical data to verify the relevance of the reported results.

AstraZeneca will continue to assess the effect of the drug on OS endpoint in the TROPION-Lung01 study.

Year to date, the stock has lost 3.8% against the industry‘s 2.2% growth.

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Per management, chemotherapy is the last resort for patients with advanced NSCLC despite limited effectiveness. Datopotamab deruxtecan is designed to target TROP2, a protein that is highly expressed in a large majority of lung cancers. There are no TROP2-directed antibody drug conjugates (“ADC”) approved for treating patients with lung cancer.

Datopotamab deruxtecan is being developed by AstraZeneca in collaboration with Daiichi Sankyo. Apart from NSCLC, the companies are evaluating the drug across multiple TROP2-targetable tumors, including breast cancer.

AstraZeneca and DaiiChi Sankyo initially entered into an agreement in 2019 to jointly develop and market Enhertu, which is currently approved in the United States across three oncology indications, namely breast cancer, stomach cancer and lung cancer. The companies expanded their agreement in 2020 to jointly develop datopotamab deruxtecan.

AstraZeneca is highly focused on strengthening its oncology business. In first-quarter 2023, AZN generated $4.1 billion worth of total revenues from its Oncology business, up 19% year over year at CER. The upside was driven by a solid performance of newer medicines, such as Tagrisso, Lynparza, Imfinzi and Calquence. AstraZeneca is working to further strengthen this portfolio through label expansions and advancing oncology pipeline candidates.

 

Zacks Rank & Key Picks

AstraZeneca carries a Zacks Rank #3 (Hold).Some better-ranked stocks in the overall healthcare sector include AbbVie (ABBV - Free Report) , Novartis (NVS - Free Report) and Vertex Pharmaceuticals (VRTX - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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