Phase III ALUR study shows Alecensa (alectinib) reduces risk of death in anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer.- Roche.
Roche announced results from the global phase III ALUR study showing that Alecensa (alectinib) significantly reduced the risk of disease worsening or death (progression-free survival, PFS) by 85% compared to chemotherapy in patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC), who had progressed following treatment with platinum-based chemotherapy and crizotinib. Median PFS reported by the investigators, the primary endpoint of the study, was 9.6 months in patients who received Alecensa compared with 1.4 months in those who received chemotherapy. Median PFS assessed by an independent review committee (IRC), a secondary endpoint, was 7.1 months for patients who received Alecensa versus 1.6 months for patients who received chemotherapy.
It also showed an overall response rate (ORR) of 36.1% for Alecensa versus 11.4% for chemotherapy and that the central nervous system (CNS) ORR in patients with measurable disease of 54.2% for Alecensa versus 0% for chemotherapy. The safety profile of Alecensa was consistent with that observed in previous studies and compared favourably to chemotherapy. The ALUR data will be presented at the European Society for Medical Oncology (ESMO) 2017 Congress.
Comment: Alecensa is approved as a monotherapy for patients with ALK-positive NSCLC who have progressed on or are intolerant to crizotinib in the United States, Europe, Kuwait, Israel, Hong Kong, Canada, South Korea, Switzerland, India, Australia, Singapore, Thailand and Taiwan. Alecensa is also approved in Japan for patients whose tumours were advanced, recurrent or could not be removed completely through surgery (unresectable). In the United States, Alecensa was granted accelerated approval by the US Food and Drug Administration (FDA) in December 2015 for the treatment of patients with ALK-positive NSCLC who have progressed on or are intolerant to crizotinib.
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