On May 11, 2017 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that the results of the Japanese phase III study (J-ALEX) of Alecensa, in patients with ALK fusion gene positive non-small cell lung cancer (NSCLC), were published in the electronic version of "The Lancet" on May 11, 2017 (Press release, Chugai, MAY 10, 2017, View Source [SID1234519004]). Schedule your 30 min Free 1stOncology Demo! (http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)30565-2/fulltext)
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The initial results of the J-ALEX study were presented at a session of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting held in Chicago, on June 6, 2016.
"The publication of the J-ALEX study results in ‘The Lancet’ assures the firm position of Alecensa in the first line therapy of patient with ALK fusion gene positive NSCLC," said Dr. Yasushi Ito, Senior Vice President, Head of Project & Lifecycle Management Unit. "We believe that Alecensa will also contribute to improving the outcomes for patients in first line therapy, as well as second line therapy in the future."
The J-ALEX study was an open-label, randomized phase III study that compares the efficacy and safety between Alecensa and crizotinib. The J-ALEX study enrolled 207 ALK-inhibitor naïve patients with ALK fusion gene positive advanced or recurrent NSCLC, who either had not undergone chemotherapy or had undergone one chemotherapy regimen. The primary endpoint of the J-ALEX study was progression free survival (PFS) as assessed by an independent review board. The secondary endpoints included overall survival, objective response rate, safety, and other endpoints.
The PFS hazard ratio of the Alecensa arm to the crizotinib arm was 0.34 (99.7% CI: 0.17-0.71, stratified log-rank p<0.0001) and Alecensa demonstrated significantly prolonged PFS. Median PFS was not reached (95% CI: 20.3-Not Estimated) in the Alecensa arm while it was 10.2 months (95%CI: 8.2-12.0) in the crizotinib arm. In the Alecensa arm, constipation (35%) was an adverse event (AE) with >30% frequency, while in the crizotinib arm nausea (74%), diarrhea (73%), vomiting (58%), visual disturbance (55%), dysgeusia (52%), constipation (44%), ALT elevation (32%), and AST elevation (31%) were each seen in >30% patients. Grade 3-4 AEs occurred in 26% of the Alecensa arm and in 52% of the crizotinib arm, there were no treatment-related deaths in either arm.
In February 2016, Chugai carried out a prospectively-defined interim analysis and had an independent data monitoring committee examine the results. Since the results showed that the Alecensa arm significantly prolonged the PFS, the committee decided to recommend an early discontinuation of the J-ALEX study.
Based on the results of the J-ALEX study, Alecensa was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration in September 2016 for first line therapy of patients with ALK-positive non-small cell lung cancer.