Proactive Investors - AstraZeneca PLC (LON:AZN) shares fell to a five-month low after it confirmed that another failed cancer trial of its Dato-DXd drug.
The largest company in the FTSE 100 said it will continue to talk to regulators despite Phase III trial results of datopotamab deruxtecan (Dato-DXd) on patients with late-stage breast cancer showed it “did not achieve statistical significance”, ie help survival rates, compared to typical chemotherapy treatment.
AstraZeneca said that as multiple antibody drug conjugates had been approved during the course of the trial, including its own Enhertu (trastuzumab deruxtecan), “subsequent treatment following patients' disease progression or treatment discontinuation is likely to have affected survival results”, noting that Dato-DXd had demonstrated meaningful improvements in survival and better patient outcomes in previous trials.
Susan Galbraith, the company’s oncology research chief, said the trial results showed “there is evidence of the clinical value of datopotamab deruxtecan in this setting.
“We will continue discussions with regulatory authorities and apply insights from these results to our clinical development programme for datopotamab deruxtecan in breast cancer.”
Dato-DXd is being jointly developed by AstraZeneca and Daiichi Sankyo, whose R&D chief Ken Takeshita noted that the drug “has previously shown a statistically significant progression-free survival benefit” in the breast cancer study, “a result supported by multiple meaningful secondary measures including patient-reported outcomes”.
Since hitting an all-time high of £13,388 on the second trading day of September, the shares have fallen around 13%, down 1.8% today to £11,568, the lowest since April.
Two weeks ago, the company revealed a similar failure to hit a target for overall survival in patients with non-small-cell lung cancer, causing shares to fall nearly 5%.
Takeshita said “we remain committed to making datopotamab deruxtecan another potential option for patients who can benefit”.