Roche revealed positive results in two studies that investigated the capabilities of its oral investigational anaplastic lymphoma kinase inhibitor (ALKi) dubbed alectinib with the drub being able to shrink tumours in people with advanced ALK-positive (ALK+) non-small cell lung cancer (NSCLC) whose disease had progressed following treatment with crizotinib.
The results are based on two studies – one global and the other one in North Amedica – with overall response rate (ORR) at 50 per cent and 47.8 per cent respectively. The study also found that alectinib shrank tumours in people whose cancer had spread to the central nervous system (CNS) with ORR of 57.1 per cent and 68.8 per cent respectively.
The company further revealed in its press release that people whose tumours shrank in response to alectinib continued to respond for a median of 11.2 and 7.5 months respectively.
Alectinib demonstrated a safety profile consistent with that observed in previous studies. The most common adverse events (Grade 3 or higher occurring in at least 2 per cent of people) were an increase in muscle enzymes (increased blood levels of creatine phosphokinase), increased liver enzymes and shortness of breath (dyspnea).
“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.”
Dr. Sai-Hong Ignatius Ou, associate clinical professor, University of California, Irvine will be presenting the results of the global study at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO), while Dr. Leena Gandhi, assistant professor of medicine, Dana-Farber Cancer Institute, Boston will be presenting the North American study.
Back in June 2013, the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to alectinib for people with ALK+ NSCLC whose disease progressed on crizotinib. This paved the way to expedite the development and review of medicines intended to treat serious diseases and to help ensure patients have access to them through FDA approval as soon as possible. Alectinib was made available in to patients in Japan in September 2014 and is marketed in Japan by Chugai Pharmaceutical, a member of the Roche Group.