Market
Outcome of next major clinical trial for Dato-DXd by end of 2025?
2
Resolution / Starting Odds
Significant survival improvement • 25%
No significant survival improvement • 25%
Trial stopped early for efficacy • 25%
Trial stopped early for safety concerns • 25%
Clinical trial results published in scientific journals or press releases
Story
AstraZeneca and Daiichi Sankyo Withdraw EU Application for Lung Cancer Drug Datopotamab Deruxtecan Due to Non-Significant Survival Improvement
Dec 24, 2024, 11:37 AM
AstraZeneca, in collaboration with Daiichi Sankyo, has voluntarily withdrawn its marketing authorization application for the lung cancer drug datopotamab deruxtecan ($Dato-DXd) from the European Union's medicines regulator. The decision follows feedback from the European Medicines Agency after trial results from the phase advanced study TROPION-Lung01 showed that the drug did not significantly improve patient survival rates. The drug, also known as Dato-DXd, had previously received the designation of innovative therapy from the U.S. Food and Drug Administration earlier this month for its results in treating a specific type of lung cancer. Dato-DXd belongs to a promising group of treatments known as antibody-drug conjugates.
View original story
Similar markets
Yes • 50%
No • 50%
No • 50%
Yes • 50%
Neutral results requiring further study • 25%
Positive results leading to Phase 2 • 25%
Other outcome • 25%
Negative results halting development • 25%
Negative results • 33%
Positive results • 33%
Inconclusive results • 34%
No • 50%
Yes • 50%
Request for more data • 34%
Rejected • 33%
Approved • 33%
Negative efficacy, but good safety • 25%
Positive efficacy, but safety concerns • 25%
Positive efficacy and safety results • 25%
Negative efficacy and safety concerns • 25%
Trial cancelled • 25%
Falls short of expectations • 25%
Exceeds expectations • 25%
Meets expectations • 25%
Withdrawn by Axsome • 25%
Rejected • 25%
Approved • 25%
Conditional Approval • 25%
European Union • 25%
Other • 25%
China • 25%
Japan • 25%