Genentech last week announced the positive results of the J-ALEX study in Japan.
The clinical trial showed that Alecensa (alectinib) reduced
the risk of disease progression or death in participants with advanced or
recurrent, ALK-positive non-small cell lung (NSCLC) cancer by 66 percent. In
the study, Alecensa was compared to crizotinib.
"This is the first investigational study to show Alecensa helped people live longer without their disease getting worse compared to crizotinib," Chief Medical Officer and Head of Global Product Development Dr. Sandra Horning said. "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."
The J-ALEX study randomized the 207 participants in a one-to-one ratio. The median progression-free survival (PFS) for the Alecensa patients was not reached by 20.3 months, versus 10.2 months for the crizotinib patients. The Japanese trial was conducted by Chugai Pharmaceutical Company Ltd., a member of the Roche Group. Genentech is also part of the Roche Group.
NSCLS is the most common form of lung cancer, comprising approximately 85 percent of all lung cancers. An estimated 224,000 Americans will be diagnosed with lung cancer in 2016 and approximately 60 percent will be diagnosed at an advanced stage of the disease.