- After reports of an increased incidence of interstitial lung disease in clinical trial subjects with lung cancer who were being tested with a combo of AZD9291 and durvalumab, AstraZeneca (AZ) decided to stop enrollment in a pair of trials.
- Interstitial lung disease can lead to dangerous scarring and impaired pulmonary function.
- AZ has emphasized that the pauses are temporary.
Although AZ is halting the trials, patients who are already enrolled in the studies will be given new consent forms, confirming that they understand the risks.
The researchers were intially confused by the safety concerns, because when tested alone both AZD9291 and durvalumab were safe and not associated wtih an increased risk of interstitial lung disease. The concern now is that these two drugs may not be able to be used in a cocktail or that the regimen will need to be carefully modified and tested.
Individually, AZD9291 is in competition with a similar drug from Clovis Oncology - rociletinib. It's also intended to compete with similar drugs from Merck and Bristol-Myers Squibb (BMS).
AZ has repeatedly committed to achieving $45 billion in sales by 2023. A relatively large part of that amount is expected to come from sales of AZD9291 and durvalumab, with contributions of $3 billion and $6.5 billion, respectively, making this a critical issue for the company to monitor.