Roche’s lung cancer therapy got the Ministry of Food and Drug Safety’s approval last week to be used as first-line therapy for a specific type of lung cancer, Roche Korea said Thursday.
Alecensa (alectinib) has been used since April last year to treat anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer patients who had previous treatment with Xalkori (crizotinib) but whose tumors have locally advanced or metastasized.
The most recent approval allows patients not treated with crizotinib or without prior treatment experience to be used as first-line therapy. The U.S. FDA and European EMA granted the same expanded indication for Alecensa in November and December, according to Roche Korea.
The approval was based on a global phase 3 ALEX trial on 303 patients with ALK-positive locally advanced or metastatic NSCLC who had previously not received treatment. Patients in the clinical trial were randomly assigned to receive either alectinib or crizotinib with the Alecensa arm proving a 53 percent lower disease progression or mortality risk than the crizotinib group. Patients taking Alecensa also had a progression-free survival rate of 25.7 months, which was 2.5 times the comparison arm.
The metastasis incidence rate to the central nervous system (CNS) in the Alecensa arm was also superior to the control arm at 9.4 percent versus 41.4 percent, according to Roche. The time for CNS metastasis to occur after treatment was also significantly longer in the Alecensa treated group, it added.
As for adverse effects, around 41 percent of patients taking Roche’s drug experienced grade 3-5 adverse effects versus 50 percent in the crizotinib arm experiencing the same. Adverse events of anemia, myalgia, elevated serum bilirubin, weight gain, musculoskeletal pain, and photosensitization were expressed more in those taking Roche’s drug while vomiting, diarrhea, and nausea was shown more in those taking crizotinib.