Phase III study shows Genentech’s Alecensa was superior to crizotinib in a specific type of lung cancer

Results showed that people treated with Alecensa lived significantly longer without their disease progressing compared to crizotinib when given as initial (first-line) treatment.

“Our goal is to transform the standard of care and we are excited to share these results with the lung cancer community,” said Sandra Horning, chief medical officer and head of Global Product Development. “As part of its Breakthrough Therapy Designation, we hope to bring Alecensa as an initial treatment for people with ALK-positive NSCLC as soon as possible and will discuss these data with global health authorities.”

Full data from the ALEX study will be presented at an upcoming medical meeting and submitted to global health authorities, including the FDA, which in September 2016 granted Alecensa Breakthrough Therapy Designation (BTD) for the treatment of people with advanced ALK-positive NSCLC who have not received prior treatment with an ALK inhibitor.

Alecensa was granted accelerated approval by the FDA in December 2015 for the treatment of people with ALK-positive NSCLC who have progressed on or are intolerant to crizotinib. The ALEX study is part of the company’s commitment to convert the current accelerated approval of Alecensa in people with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib to a full approval as an initial treatment.

ALK-positive NSCLC is a distinct form of lung cancer commonly diagnosed in younger people (median age 52). Approximately 54 percent of cases are found in women. ALK-positive NSCLC is also generally found in those with a light or non-smoking history.