Investigational medicine alectinib shrank tumours in nearly half of people with specific type of lung cancer

Roche has announced positive results from two pivotal studies that showed alectinib shrank tumours in people with advanced ALK-positive (ALK+) non-small cell lung cancer (NSCLC) whose disease had progressed following treatment with crizotinib.

In addition, alectinib was shown to shrink tumours in people whose cancer had spread to the central nervous system (CNS). Additionally, 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 were an increase in muscle enzymes, increased liver enzymes and shortness of breath.

Roche plan to submit these data to the FDA to support alectinib as a new treatment option

“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).

Alectinib was granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) in June 2013 for people with ALK+ NSCLC whose disease progressed on crizotinib. Breakthrough Therapy Designation is designed 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.

ALEX, a global randomised Phase III study, is ongoing, comparing alectinib to crizotinib as an initial treatment for people with advanced NSCLC whose tumours were characterised as ALK+.