Roche said a second Phase III study has shown that non-small-cell lung cancer (NSCLC) patients treated with its oral anaplastic lymphoma kinase (ALK) inhibitor Alecensa® (alectinib) stayed alive without their disease worsening for significantly longer than those treated using Pfizer’s Xalkor® (crizotinib). The open-label, global Phase III ALEX study pitched Alecensa and crizotinib head-to-head as first-line therapy for ALK fusion gene-positive NSCLC in 303 treatment-naïve adult patients.

“Following the Japanese Phase III J-ALEX study, the ALEX study, the head-to-head trial with crizotinib, Alecensa demonstrated a significant prolongation of progression-free survival (PFS) compared to crizotinib,” said Dr. Yasushi Ito, svp, head of Project & Lifecycle Management Unit at the Roche company, Chugai, which originally discovered Alecensa.

The FDA approved Alecensa in December 2015 as second-line therapy for ALK-positive NSCLC in patients whose disease had progressed after, or who were intolerant to, crizotinib. In February this year, the EC granted the drug accelerated approval for treating ALK-positive advanced NSCLC, again in patients previously treated with crizotinib.

Roche said full data from the ALEX study will be presented at a forthcoming meeting, and will also be submitted to global regulators, including the FDA, with a view to getting Alecensa approved as first-line treatment for ALK-positive NSCLC. 

Based on data from the Japanese J-ALEX study, in October 2016 the FDA granted Alecensa Breakthrough Therapy Designation for treating ALK-positive NSCLC in patients who hadn’t received prior treatment with an ALK inhibitor. “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, said Sandra Horning, M.D., chief medical officer and head of Global Product Development at the Roche company, Genentech.”

Japan’s regulator approved Alecensa for treating ALK fusion gene-positive, unresectable, recurrent/advanced NSCLC in July 2014. “We believe that Alecensa will also contribute to improving the outcomes for overseas patients from first line therapy in the future,” added Dr. Yasushi Ito.

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