Alectinib success in advanced ALK positive NSCLC tumours (NP28673 and NP28761 studies) -Genentech/Roche

Genentech, announced positive results from two pivotal studies (NP28673 and NP28761) that showed alectinib, its oral investigational anaplastic lymphoma kinase (ALK) inhibitor, shrank tumors (overall response rate; ORR: 50.0 percent and 47.8 percent, respectively) in people with advanced ALK-positive non-small cell lung cancer (NSCLC) whose disease had progressed following treatment with crizotinib. In addition, alectinib was shown to shrink tumors in people whose cancer had spread to the central nervous system (CNS) (CNS ORR: 57.1 percent and 68.8 percent, respectively). People whose tumors shrank in response to alectinib continued to respond for a median of 11.2 and 7.5 months, respectively (duration of response; DOR).

Alectinib demonstrated a safety profile consistent with that observed in previous studies. The most common adverse events (Grade 3 or higher occurring in at least 2 percent of people) were an increase in muscle enzymes (increased blood levels of creatine phosphokinase), increased liver enzymes and shortness of breath (dyspnea).