EU Follows US and Approves Chugai's ALK Inhibitor "Alecensa®" as First Line Therapy for ALK-Positive

 Chugai Pharmaceutical Co., Ltd (TOKYO:4519) announced today that F. Hoffmann-La Roche Ltd. obtained approval from the European Commission, for Alecensa® as monotherapy indicated for "the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)". In addition, the EU marketing authorisation for Alecensa has been switched from conditional approval (given in February 2017) to a full approval for the treatment of people with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib (second-line).

"Following approval for first line treatment in the US in November 2017, it is a great pleasure for Chugai that Alecensa has been approved for primary treatment in the EU. An improvement in prognosis is expected in patients with ALK-positive advanced NSCLC who receive treatment with Alecensa at an early stage," said Dr. Yasushi Ito, Chugai’s Senior Vice President, Head of Project & Lifecycle Management Unit. "In addition to the J-ALEX study (JapicCTI-132316) conducted in Japan, results of the ALEX study (NCT02075840) conducted overseas also showed that this will be great news for patients. We are convinced that Alecensa can contribute to the treatment of many patients in the world."

This additional approval is based on results from the phase III ALEX study (NCT02075840).
The ALEX study (NCT02075840) evaluates the efficacy and safety of Alecensa compared with crizotinib in people with ALK-positive NSCLC who had not received prior systemic therapy (first-line). In the study, Alecensa significantly reduced the risk of disease worsening or death by 53% (HR=0.47, 95%CI: 0.34-0.65, stratified log-rank test, p<0.001) compared to crizotinib as assessed by investigators. Median progression-free survival (PFS) was 25.7 months (95%CI: 19.9-not estimable) for people who received Alecensa compared with 10.4 months (95%CI: 7.7-14.6) for people who received crizotinib as assessed by independent review committee. The safety profile of both drugs was consistent with that observed in previous studies, with no new findings.

In addition, Alecensa significantly reduced the risk of the cancer spreading to or growing in the brain or central nervous system (CNS) compared to crizotinib by 84% (HR=0.16, 95%CI: 0.10-0.28, stratified log-rank test, p<0.001). This was based on a time to CNS progression analysis in which there was a lower risk of progression in the CNS as the first site of disease progression for people who received Alecensa (12%) compared to people who received crizotinib (45%).