Study reveals Alecensa is effective against specific type of lung cancer in Japanese patients

Roche has announced that Alecensa, an oral anaplastic lymphoma kinase (ALK) inhibitor, reduced the risk of disease worsening or death in Japanese people with advanced or recurrent, ALK-positive non-small cell lung cancer (NSCLC).

Roche’s Phase III study, an investigational head-to-head study of Alecensa versus crizotinib in people with advanced ALK-positive non-small cell lung cancer (NSCLC), revealed a 66 percent reduction in the disease worsening or death (progression free survival, PFS) compared to crizotinib in Japanese people with advanced or recurrent NSCLC. (hazard ratio [HR]=0.34, 99 percent CI: 0.17-0.70, p<0.0001). Median PFS was not reached in people who received Alecensa (95 percent CI: 20.3 months-not reached) versus 10.2 months median PFS (95 percent CI: 8.2-12.0) in people who received crizotinib. The results were from a pre-specified interim analysis from the Phase III J-ALEX study in people who had not received prior treatment with an ALK-inhibitor. There were fewer adverse events (AEs) in the Alecensa arm versus the crizotinib arm. Alecensa demonstrated a safety profile consistent with that observed in previous studies with no new or unexpected AEs.

Head-to-head study of Alecensa versus crizotinib

“This is the first investigational study to show Alecensa helped people live longer without their disease getting worse compared to crizotinib,” said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development. “We believe these efficacy and safety results represent a clinically meaningful advancement for people with ALK-positive lung cancer, and we plan to discuss these data with health authorities, including the FDA.”

Alecensa was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in December 2015 for the treatment of people with ALK-positive NSCLC who have progressed on or are intolerant to crizotinib. ALEX, a global, randomised Phase III study, is ongoing, comparing Alecensa to crizotinib as an initial (first-line) treatment for people with advanced NSCLC whose tumours were characterised as ALK-positive by a companion VENTANA ALK (D5F3) CDx Assay immunohistochemistry (IHC) test developed by Roche Tissue Diagnostics. This study is part of the company’s commitment to convert the current accelerated approval in people with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib to a full approval as an initial treatment.