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Studies Find Alectinib Shrinks Tumors in Nearly Half of ALK+ NSCLC Patients

Response rates near 69% in central nervous system of people with advanced disease

Results from two pivotal phase I/II studies show that alectinib (Roche) shrank tumors in people with advanced ALK-positive non–small cell lung cancer (NSCLC) whose disease had progressed following treatment with crizotinib, including patients whose cancer had spread to the central nervous system.

Overall response rates (ORRs) for alectinib, an oral investigational anaplastic lymphoma kinase inhibitor, were 50% in trial NP28673 and 47.8% in trial NP28761, Roche said. People whose tumors shrank in response to alectinib continued to respond for a median of 11.2 and 7.5 months, respectively.

 “Cancer spreads to the brain in about half of people with ALK-positive lung cancer, and these studies suggest that alectinib can shrink tumors in people with this difficult-to-treat disease,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development.

NP28673 is a phase I/II global, single arm, open-label, multicenter trial evaluating the safety and efficacy of alectinib in 138 people with ALK-positive NSCLC whose disease progressed on crizotinib. The study showed by assessment of an independent review committee an ORR in 50.0% of people treated with alectinib, as measured by RECIST criteria. An investigator assessment also showed tumors shrank in 47.8% of people who received alectinib.

Central nervous system (CNS) tumors shrank in response to alectinib in 57.1% of people whose disease had spread to the brain or other parts of the CNS. In addition, the people whose tumors shrank in response to alectinib continued to respond for a median of 11.2 months (immature data). The median progression-free survival (PFS) for people who received alectinib was 8.9 months.

NP28761 is a phase I/II North American, single-arm, open-label, multicenter trial evaluating the safety and efficacy of alectinib in 87 people with ALK-positive NSCLC whose disease progressed on crizotinib. The study showed by assessment of an independent review committee an ORR in 47.8% of people treated with alectinib, as measured by RECIST criteria. An investigator assessment showed tumors shrank in 46.0% of people who received alectinib.

CNS tumors shrank in response to alectinib in 68.8% of people whose disease had spread to the brain or other parts of the CNS. The people whose tumors shrank in response to alectinib continued to respond for a median of 7.5 months (immature data). The immature median PFS was 6.3 months.

Alectinib demonstrated a safety profile consistent with that seen in previous studies. The most common adverse events (grade 3 or higher occurring in at least 2% of people) were increased blood levels of creatine phosphokinase, increased liver enzymes, and dyspnea.

Results from both studies will be presented at the 51st Annual Meeting of the American Society of Clinical Oncology, on May 31 and June 1.

Alectinib was granted a breakthrough therapy designation by the FDA in June 2013 for people with ALK-positive 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 September 2014 in Japan, where it is marketed by Chugai Pharmaceutical, a member of the Roche Group. Alectinib was created at Chugai Kamakura Research Laboratories.

ALEX, a global, randomized phase III study, is comparing alectinib to crizotinib as a first-line treatment for people with advanced NSCLC whose tumors were characterized as ALK-positive by the investigational companion immunohistochemistry test being developed by Roche. ALK-positive NSCLC often affects younger people who have a light smoking or nonsmoking history. It is almost always found in people with a specific type of NSCLC called adenocarcinoma.

Source: Roche; May 14, 2015.

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