Shares in AstraZeneca fell by 6% on July 3 when the company published the first results from its Phase III trial for datopotamab deruxtecan (Dato-DXd) and continued to fall throughout the day, though there was some recovery on July 4.
It was reported that the therapy demonstrated statistically significant improvement in progression-free survival vs docetaxel in previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC).
However, for the dual primary endpoint of overall survival (OS) an early trend was observed “that did not meet the prespecified threshold for statistical significance”.
According to the Financial Times, Credit Suisse analysts said that they had expected investor disappointment at the news because of “high expectations for a positive clinically-meaningful result”.
Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo.
The companies say the trial will continue as planned to assess OS with greater maturity.
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, commented: “These first Phase III trial results from the datopotamab deruxtecan clinical programme provide compelling evidence for the potential role this TROP2-directed antibody drug conjugate can play in treating patients with lung cancer.”
Ken Takeshita, Global Head, Oncology R&D, Daiichi Sankyo, added: “We are encouraged by the statistically significant results of the dual primary endpoint of progression-free survival seen with datopotamab deruxtecan and look forward to the final overall survival analysis. We plan to share these data with regulatory authorities to discuss next steps.”
