- Advanced breast cancer drug trial disappoints
- Drug unlikely to receive US approval
- Several trials could yet revive hopes
Anglo-Swedish pharmaceutical giant AstraZeneca (AZN) was on the back foot on Monday after reporting disappointing late-stage trial results for Dato-DXd, its precision advanced breast cancer experimental drug.
The news sent the shares down 1.4% to £116.10, a new three month low and follows fast on the heels of similarly disappointing results from lung cancer trials released in August.
WHY WERE THE RESULTS DISAPPOINTING?
The company said that despite Dato-DXd previously demonstrating a clinically meaningful improvement in PFS (progression-free survival), it did not achieve statistical significance in the final overall survival analysis of patients with advanced inoperable breast cancer.
Overall survival is a key measure for assessing the efficacy of a treatment and represents the length of time a patient survives from the start of a treatment.
Susan Galbraith, executive vice president at AstraZeneca, said: ‘Based on the TROPION-Breast01 results, there is evidence of the clinical value of Dato-DXd in this setting.
‘We will continue discussions with regulatory authorities and apply insights from these results to our clinical development programme for Dato-DXd (datopotamab deruxtecan) in breast cancer.’
WILL THE DRUG GET APPROVED?
Sean Conroy, healthcare analyst at Shore Capital, described the news as ‘somewhat’ disappointing given the study had previously demonstrated a 37% reduction in the risk of disease progression or death.
‘We expect a decision from the FDA (Food and Drug Administration) on approval in H1 2025. However, in the absence of a clear OS (overall survival) benefit, we believe that approval now looks less likely’, commented Conroy.
Mitigating those concerns, Conroy believes the bigger picture is more encouraging for this type of drug.
‘We would highlight these are just one piece in a bigger picture forming that dato’ could potentially replace mainstay, systemic chemotherapy across a range of cancers.
‘The Phase III programme for dato’ is extensive and we note the wave of readouts coming that could renew sentiment’, added Conroy.
