- Late-stage lung cancer trial disappoints
- Treatment was expected to be ‘blockbuster’
- US regulatory approval now in doubt
Shares in pharmaceutical giant AstraZeneca (AZN), fell more than 5% to a one month low after the UK’s largest quoted company released disappointing data from a late-stage clinical trial of its precision lung cancer drug Dato-DxD.
The shares have been on a tear over the last six months, gaining around 20% before today’s fall compared with a 7% gain in the FTSE 100 index, so some profit taking is not surprising.
In a presentation to the World Conference on Lung Cancer in San Diego, the company revealed the TROPION-lung01 trial ‘did not reach statistical significance’ in terms of improving overall survival rates in patients suffering from non-small cell lung cancer.
WHY DID THE SHARES FALL?
There were high hopes for the experimental treatment Data-DxD with analysts forecasting peak sales of $5 billion, representing another potential blockbuster for AstraZeneca.
In a research note ahead of the conference on 2 September, analysts at Berenberg said the readout from the trial would inform expectations on the likelihood of US FDA (Food and Drug Administration) approval in the fourth quarter.
This is not the first-time results from trials of Data-DxD have knocked the shares. In July 2023, the stock price fell 8% after the company released interim data which showed the treatment did not demonstrate a clinically meaningfully improvement on overall survival rates for the wider patient cohort.
Data-DxD is being jointly developed with Japanese partner Daiichi Sango (4568:TYO) and belongs to a group of antibody drug conjugates designed to precisely target tumours with a cell-killing payload without damaging healthy cells.
