October 9, 2015
By Alex Keown, BioSpace.com Breaking News Staff
LONDON – AstraZeneca PLC has halted two clinical trials testing the combination of AZD9291 and durvalumab for lung cancer following reports of interstitial lung disease-like reports in one trial, Reuters reported this morning.
London-based AstraZeneca halted the trials combining its experimental compound combination to treat advanced non-small cell lung cancer. AstraZeneca said patients participating in the trials, Tatton and Caural, will receive updated consent forms before the company decides whether or not to continue with the trial. There have been no deaths reported with the development of interstitial lung disease, Reuters said. Tatton is an early-stage trial, while Caural is a late-stage test combining the two drugs, Bloomberg Business reported. Interstitial lung disease is characterized by progressive scarring of the lung tissue between the air sacs. The disease can inhibit breathing.
The halting of the trials may have stymied some of the momentum AstraZeneca was gaining from AZD9291. In September, AstraZeneca presented data from its AURA Phase I and II studies showing progression free symptoms over a one-year period in 72 percent of patients administered AZD9291 to first-line patients with epidermal growth factor receptor mutation (EGFRm) positive advanced non-small cell lung cancer (NSCLC) and previously treated patients with EGFR T790M mutation-positive NSCLC.
In June, AstraZeneca submitted marketing authorization to the U.S. Food and Drug Administration (FDA). Earlier the FDA gave priority review to AZD9291. The drug had already been awarded Breakthrough Therapy designation, Orphan Drug and Fast Track status. Should AZD9291 make it to market, the drug is expected to yield annual revenue of approximately $3 billion.
The halting of the trial could limit AstraZeneca’s ability to combine AZD9291 with other drugs, something that could be good news for rival drugmaker Boulder, Colo.-based Clovis Oncology . According to data released by Clovis, the experimental drug roceletinib is effective in treating a specific EGFR T790M mutation, as well as the T790 mutation.
The FDA accepted Clovis’ New Drug Application for the experimental oncology drug and granted it priority review status, which is expected sometime in March of 2016. Clovis has also sought marketing authority with the European Medicine’s agency.
AstraZeneca’s is down slightly this morning, currently trading at $32.24 per share. Meanwhile, Clovis’ is up, currently trading at $92.08 per share.
AZD9291 and its combination drug durvalumab are promising cancer treatments not only for lung cancers, but also for other types of cancer, Reuters said. Durvalumab is part of AstraZeneca’s immuno-oncology pipeline drugs known as a PD-L1 immune checkpoint inhibitor. In August, AstraZeneca struck a deal with Peregrine Pharmaceuticals, Inc. to study that company’s investigational phosphatidylserine (PS)-signaling pathway inhibitor, bavituximab, in combination with durvalumab.
Durvalumab is a monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumors avoid detection by the immune system.
Preclinical data have demonstrated that by combining the enhanced T-cell mediated anti-tumor activity of bavituximab with checkpoint inhibitors like PD-L1 antibodies, the ability of tumor-specific T-cells to continue attacking the tumor is prolonged.
AstraZeneca has been developing multiple immuno-oncology treatments and this year has moved deeper into the field. In January, AstraZeneca tapped Robert Iannone as the head of its immuno-oncology development programs.
