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Shares in AstraZeneca dropped nearly 5 per cent on Tuesday after its failure to hit a target in trials for a next-generation lung cancer drug set back its ambitions to offer precision oncology treatments to more patients.
The company’s datopotamab deruxtecan (Dato-Dxd) failed to reach “statistical significance” for overall survival in patients with metastatic non-small-cell lung cancer, a hard-to-treat form of the disease.
Detailed results from a late-stage trial showed that patients on the drug survived just under 13 months on average, compared with almost 12 months on the current standard chemotherapy drug. The difference was too small to be statistically significant.
A so-called non-squamous subset of these patients showed a 2.3 month improvement, a result the drugmaker said was “clinically meaningful”.
But the results mean the drug may face more regulatory hurdles and delays to a Food and Drug Administration deadline to approve the treatment for December 20, according to Stephen Barker, an analyst at Jefferies. They could also limit the amount of patients who will receive the drug. In addition, patients might need advance testing to determine whether they are suitable for the treatment.
“The results [were] not as perfect as we would like and so people are questioning what kind of approval we would get,” AstraZeneca’s chief executive Pascal Soriot told Bloomberg TV on Tuesday. “Dato remains a very important product for us. It’s a setback in time.”
In mid-morning in London, the company’s shares were down 61p — 4.8 per cent — at £12.10.
The targeted chemotherapy treatment — known as an antibody drug conjugate — has been closely watched by investors, as the drugmaker works to deliver on ambitions for a near-doubling in annual revenue to $80bn by 2030.
High hopes for the company’s oncology medicine helped AstraZeneca to reach a £200bn market valuation for the first time last month.
The Dato-Dxd data was presented at a lung cancer conference in San Diego on Monday. The drug was developed with Japanese company Daiichi Sankyo, with which AstraZeneca has also developed its breast cancer drug Enhertu.
Enhertu has already generated strong sales and there has been optimism that Dato-Dxd can replicate its success. But, last year, the drug also missed expectations on progression-free survival in a trial, another way of measuring the success of oncology drugs. That also hit the company’s shares.
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