AstraZeneca halts lung cancer trials amidst safety concerns
pharmafile | October 13, 2015 | News story | Manufacturing and Production | AZD9291, AstraZeneca, MEDI4736, NSCLC, drug safety, durvalumab, interstitial lung disease, lung cancer, non-small cell lung cancer
AstraZeneca is stopping two trials of a combination of two of its pipeline cancer treatments, after reports that the pairing resulted in increased incidence of interstitial lung disease in patients with lung cancer.
The trials had been evaluating the combination of AZD9291 and durvalumab (MEDI4736) in patients with non-small cell lung cancer, until data showed increased reports of the condition, which can result in dangerous scarring and impaired pulmonary function.
The individual trials of both drugs had shown good safety profiles and no association with increased risk of interstitial lung disease, however researchers are now concerned the pair may not be safe when used together.
AstraZeneca has emphasised that the trial pauses are temporary, and that patients will be given new consent forms taking into account the findings and new risks. But the company will be aware of the importance of bringing both AZD9291 and durvalumab successfully to market, as it targets sales of $45 billion by 2023.
The company has no plans to change development for either individual drug as a monotherapy, but will be aware of the future value of both as combination treatments and keen to overcome the new hurdle. The British firm faces competition from similar treatments in development by Merck and BMS in the case of durvalumab, and Clovis Oncology’s rociletinib for AZD9291.
AZD9291 targets a genetic mutation that allows tumours evade current lung cancer drugs, while the immuno-oncology treatment Durvalumab is an anti-PD-L1 therapy.
AZD9291 was awarded Promising Innovative Medicine (PIM) status by the MHRA in the UK last year.
Joel Levy
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