ASCO 2015: Investigational ALK Inhibitor Demonstrates Promising Overall Response Rates in Patients With Advanced ALK-Positive NSCLC
The oral investigational anaplastic lymphoma kinase (ALK) inhibitor alectinib shrank tumors in almost half of patients with advanced ALK-positive non–small cell lung cancer (NSCLC) whose disease had progressed following crizotinib (Xalkori) treatment. Positive results from two clinical studies were presented by Genentech at the 2015 ASCO Annual Meeting in Chicago (Abstracts 8008 and 8019).
Study Details
The global NP28673 study and the North American NP28761 study are phase I/II single-arm, open-label, multicenter trials evaluating the safety and efficacy of alectinib in patients (N= 138 and N = 87, respectively) with ALK-positive NSCLC whose disease progressed on crizotinib.
Treatment with alectinib resulted in an overall response rate of 50% and 47.8%, respectively. Patients whose tumors shrank in response to alectinib continued to respond for a median of 11.2 and 7.5 months, respectively.
The ALK inhibitor was also shown to shrink tumors in patients whose cancer had spread to the central nervous system, a secondary endpoint, with an overall response rate of 57.1% in NP28673 and 68.8% in NP28761. The median progression-free survival was 8.9 and 6.3 months (immature), 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% of people) were an increase in levels of creatine phosphokinase, increased liver enzymes, and dyspnea.
“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, Chief Medical Officer and Head of Global Product Development at Genentech. “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.”
The studies were sponsored by Hoffmann-La Roche. For full disclosures of the study authors, visit abstract.asco.org.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
