Alecensa clears the Phase III Trial as first-line therapy for ALK-positive non small cell lung cancer
Roche’s Alecensa (alectinib) has been found to be effective as first line treatment in people with anaplastic lymphoma kinase (ALK)-positive advanced non small cell lung cancer (NSCLC). The results of the global, randomised, Phase III Alex study indicated that patients treated with Alecensa showed significant reduction in disease worsening or death when compared to patients treated with crizotinib. The results were presented by Roche at the American Society of Clinical Oncology (ASCO) Annual Meeting on 6th June 2017.
About ALK-positive NSCLC
Lung cancer accounts for the highest number of deaths worldwide. Out of the total lung cancer cases, 80-85% are NSCLC. About 3-5% of non small cell lung tumors have a chromosomal rearrangement that generates a fusion gene between EML4 (echinoderm microtubule-associated protein-like 4) and ALK (anaplastic lymphoma kinase). This EML4-ALK fusion protein is oncogenic in nature and causes ALK-positive NSCLC to grow and spread to other parts of the body. ALK inhibitors are commonly used for treatment of such tumors.
Clinical Updates about Alecensa
Phase III Alex study (NCT02075840) demonstrated that Alecensa reduced the rate of disease progression in patients by 53% when compared to crizotinib.The median progression free survival was 25.7 months in Alecensa arm while it was 10.4 months in crizotinib arm. The study also showed that the drug reduced the risk of CNS tumor progression by 84%. Grade 3-5 adverse events were less in Alecensa arm as compared to crizotinib arm. FDA granted accelerated approval to Alecensa in December 2015 for the treatment of people with ALK-positive NSCLC who have progressed on or are intolerant to crizotinib. In 2016, the drug was granted Breakthrough Therapy Designation to treat advanced ALK-positive NSCLC patients who had not received any prior treatment with an ALK inhibitor. Last May, a separate Phase III J-ALEX study conducted by Roche showed that Alecensa reduced the risk of disease progression by 66% compared to crizotinib in Japanese people with advanced or recurrent ALK-positive NSCLC.
Other ALK Inhibitors
Xalkori(crizotinib) is not the only ALK inhibitor Alecensa is competing with. Zykadia (ceritinib), Alunbrig (brigatinib) and lorlatinib are some other drugs in line. FDA has granted priority review for the expanded use of Novartis’ Zykadia as a first-line treatment for NSCLC. Takeda’s Alunbrig has received accelerated approval from the FDA for the treatment of patients with ALK-positive NSCLC whose tumors are resistant to crizotinib. Pfizer’s ALK/ROS1 inhibitor lorlatinib is in phase 3 clinical trial.
Alecensa has been approved as a monotherapy for ALK-positive NSCLC patients who have progressed on or are intolerant to crizotinib in US, Europe and nine other countries across the globe. With the results obtained from Alex study Roche hopes to gain full approval of Alecensa as an initial treatment for ALK-positive non small cell lung cancer.