10th Sep 2024 10:49
(Alliance News) - AstraZeneca PLC shares weakened on Tuesday morning, after tepid results from a lung cancer drug trial left investors fretting about regulatory approval chances.
Shares fell 4.6% to 12,122.00 pence each in London on Tuesday morning.
Cambridge-based AstraZeneca said datopotamab deruxtecan, or Dato-Dxd, failed to reach "statistical significance" for overall survival in patients with metastatic non-small cell lung cancer.
The pharmaceuticals firm said in the overall trial population, overall survival results numerically favoured datopotamab deruxtecan compared to docetaxel - 12.9 months versus 11.8 months. But this did not reach statistical significance.
Jacob Sands, of the Dana-Farber Cancer Institute and investigator in the trial, said: "Despite many efforts to surpass docetaxel with novel approaches in previously treated advanced or metastatic non-small cell lung cancer, patients only survive for about one year. For datopotamab deruxtecan to show a statistically significant improvement in progression-free survival along with improved response rate, duration of response and an overall survival improvement numerically consistent with progression-free survival is clinically meaningful for patients with nonsquamous lung cancer."
Nonetheless, Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca, said the results "underscore our confidence in the important role datopotamab deruxtecan can play across segments and settings of non-small cell lung cancer."
XTB analyst Kathleen Brooks said the findings "could make it difficult to get approval" by the US Food & Drug Administration.
Swiss bank UBS cut its "probability of success for Dato-DXd" to treat the form of cancer.
"Following the disappointing OS data, we see clear risks to approval for Dato-DXd in 2nd line NSCLC, with an FDA [advisory committee] now highly likely. We lower our probability of success from 80% to 40%," UBS added.
Jefferies took a more positive stance, however, believing the "probability of approval remains high".
The investment bank noted a US FDA prescription drug user fee act date, when regulators must make a decision on a new drug application, of December 20.
"Despite the mixed OS (overall survival) results from the final analysis, we still think that FDA will approve Dato-DXd for second-line treatment of NSCLC with nonsquamous histology. The main reason
we remain optimistic is because the TL01 study has demonstrated statistically significant improvement in progression-free survival, particularly in nonsquamous patients," Jefferies added.
Nonsquamous refers to cancer which begins in peripheral lung tissue.
By Eric Cunha, Alliance News news editor
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