A drug under development by Roche Holding AG has been shown in pivotal trials to shrink tumours in patients suffering from advanced lung cancer with a specific gene mutation, which had stopped responding to crizotinib another drug in the same class.
Currently, Pfizer Inc's crizotinib, or Xalkori, had been approved for patients with advanced non-small cell lung cancer with a mutation of the ALK gene. The mutation was found in around 4 per cent of NSCLC cases.
Roche's said its alectinib, an oral ALK inhibitor, was able to cross the blood-brain barrier - an important benefit for lung cancer, which often spread to the brain.
The company said, in one trial 50 per cent of patients responded to the drug, while the response rate was 47.8 per cent in the second trial.
Further, alectinib was shown to shrink tumours in people whose cancer had spread to the central nervous system. People whose tumours were seen to have shrunk in response to alectinib continued to respond for a median of 11.2 and 7.5 months, two studies showed.
The results of the studies were released yesterday ahead of the annual meeting of the American Society of Clinical Oncology later this month.
''Cancer spreads to the brain in about half of people with ALK-positive lung cancer, and these studies suggest that alectinib can shrink tumours in people with this difficult-to-treat disease,'' said Sandra Horning, MD, chief medical officer and head of global product development. ''We plan to submit these data to the FDA this year to support alectinib as a potential new option for people whose advanced ALK-positive lung cancer progressed on crizotinib.''
Results from both studies will be presented at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO).
The NP28673 study will be presented by Dr Sai-Hong Ignatius Ou, associate clinical professor, University of California, Irvine and the NP28761 study will be presented by Dr Leena Gandhi, assistant professor of medicine, Dana-Farber Cancer Institute, Boston.