AstraZeneca has suffered a setback after disappointing late-stage results from a lung cancer drug that was closely monitored.
The FTSE-100 pharmaceutical company showed its confidence in Dato-DXd when it presented the overall survival data at a lung cancer world congress in San Diego. Analysts, however, questioned the potential benefits.
AstraZeneca shares fell by 306p or 2.4% at the close, to £124.06.
The Cambridge-based firm revealed results of a phase-III trial comparing Dato-DXd to standard chemotherapy in treating non-small-cell lung cancer. Results for patients who had received at least one prior therapy showed “a clinically meaningful trend towards improving overall survival”.
Susan Galbraith said that the results were based on data previously reported on progression-free survival and “underscored our confidence in datopotamab desuxtecan’s important role across segments and settings for non-small-cell lung cancer”.
Analysts at Bernstein, a broker, stated that the “subpopulation” which forms the basis for a regulatory application to the US Food and Drug Administration was not statistically significant and therefore, “the play of chance” could not be excluded.
Dato-DXd is being developed in collaboration with Daiichi Sankyo of Japan and is one of the key drugs that AstraZeneca has in its pipeline. It is looking to continue a successful launch of new treatments in oncology in particular, which have made it the most valuable company listed on the London Stock Exchange.
AstraZeneca announced at a capital market event in May that it expects to have more than 40 results of late-stage clinical trials by the end next year. The company also said it could generate $20 billion in revenue in 2030 through so-called “readouts” and launches in this year or next. Dato-DXd was used for breast and lung cancer.
Dato-DXd, a company that produces digital imaging devices for the automotive industry, was acquired by Daiichi Sankyo in a deal four years ago. The upfront payment of $1 billion was made. Daiichi Sankyo shares fell almost 9% in Tokyo following the release of its latest results.
Analysts at Stifel stated that investors and analysts had been following the development of this drug. They said it “made noise because results weren’t as positive and easy to read as expected”. AstraZeneca shares had fallen in July of last year due to disappointment over results that showed the drug’s ability to slow the progression lung cancer. Investors have reduced expectations of the drug’s commercial success.
Sir Pascal Soriot (65), the 65-year-old chief executive who has been overseeing the transformation of AstraZeneca’s business since 2012, stated in October that people should “stop their narrow focus on Dato DXd and take a look at the entire portfolio”.
Stifel stated: “Dato-Dxd is a drug that has definite benefits for certain patients, and it comes at an affordable price when you consider the toxicity. However, determining who exactly should be treated and how to do so are complex issues.”
AstraZeneca announced in February that a request to the FDA for America was accepted after the earlier data on progression-free survivor. A decision regarding regulatory approval is expected in the fourth-quarter of this year.
The term “progression-free” survival is used to describe the time a patient can live with a disease without it getting worse. Jefferies analysts said that the “probability of approval” remains high, given that the co-primary trial endpoint, progression-free life, was met.
Each year, more than one million people receive a diagnosis for advanced non-small cell pulmonary cancer. Although treatments have improved outcomes, most patients with advanced non-small cell lung cancer will eventually progress despite chemotherapy being the only treatment available for decades.
Bloomberg reported last week that police had detained five current and former employees for alleged illegal activity.
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