AstraZeneca suffers cancer drug trial setback

Disappointing late-stage trial results for a closely watched lung cancer drug have dealt a blow to AstraZeneca.

The FTSE 100 pharmaceuticals company expressed its confidence in datopotamab deruxtecan, or Dato-DXd, when it presented overall survival data for the treatment at a world lung cancer congress in San Diego, but analysts promptly questioned the strength of the possible benefits.

That, in turn, weighed on AstraZeneca’s share price, which was down by 508p, or 4 per cent, at £122.04 in afternoon trading.

Unveiling results from a phase III trial of Dato-DXd in treating a type of non-small cell lung cancer, compared with standard chemotherapy, the Cambridge-based company said that results for the study, in patients who had undergone at least one previous therapy, showed a “clinically meaningful trend toward improving overall survival”.

Susan Galbraith, executive vice-president of oncology research and development at AstraZeneca, said the results built on previously reported progression-free survival data and “underscore our confidence in the important role datopotamab deruxtecan can play across segments and settings of non-small cell lung cancer”.

However, analysts at Bernstein, the broker, said that in the “sub-population” that forms the basis of a regulatory application for the drug to the US Food and Drug Administration, its “superiority, a 2.3-month overall survival benefit over chemotherapy, wasn’t statistically significant” and that therefore “the ‘play of chance’ could not be excluded from these results”.

Dato-DXd, which is being developed jointly with Daiichi Sankyo, of Japan, is among the key drugs in AstraZeneca’s pipeline as it looks to continue the successful launch of a series of new treatments, particularly in oncology, that have transformed it into the most valuable company on the London Stock Exchange.

At a capital markets event in May at its new research and development centre in Cambridge, AstraZeneca said it expected more than 40 late-stage clinical trial results by the end of next year, with about $20 billion of potential revenue in 2030 from so-called readouts and launches this year and next. These included Dato-DXd for lung and breast cancer.

Dato-DXd was acquired through a deal with Daiichi Sankyo for an upfront $1 billion four years ago. Shares in Daiichi Sankyo fell by almost 9 per cent in Tokyo after news of the latest results emerged.

Investors and analysts have been tracking the development of the drug, which analysts at Stifel said had “made noise in the past because results were not as positive and easy-to-read as expected”. Indeed, shares in AstraZeneca previously weakened in July last year amid disappointment at results showing the benefits for slowing the progression of lung cancer. Investors have reduced their commercial expectations for the medicine.

Sir Pascal Soriot, 65, the chief executive of who has overseen the transformation of AstraZeneca since 2012, said in October that he hoped people would “stop their myopic focus on Dato-DXd and look at the rest of the portfolio”.

Stifel said: “There is an unequivocal benefit with Dato-Dxd for some patients and at a reasonable price in terms of toxicity, but the exact target population and how it should be addressed are complex topics.”

In February, AstraZeneca said that an application to the FDA in America had been accepted for Dato-DXd after the earlier progression-free survival data and that a decision on regulatory approval was expected in the fourth quarter of this year.

Progression-free survival refers to the length of time during and after treatment that a patient lives with the disease but it does not get worse. Analysts at Jefferies said that “given that one of the trials’ co-primary end-points, progression-free survival, has been met, the probability of approval remains high”.

More than a million people are given a diagnosis of advanced non-small cell lung cancer each year. Although therapies have improved outcomes, the disease eventually progresses for most patients who receive chemotherapy, which for decades has been the last treatment available, despite “limited effectiveness and known side-effects”.

Last week AstraZeneca confirmed that a “small number” of its employees in China, an important market for the company and its cancer drugs, were under investigation after Bloomberg reported that five present and former staff had been detained by police over alleged illegal activities.