The biotechnology company Genentech recently announced that its product Alecensa (alectinib) was superior in reducing disease worsening risk or death in a specific type of lung cancer, compared to treatment with crizotinib. Researchers measured the effects through theJ-ALEX study using Japanese patients who had advanced or recurrent ALK-positive non-small cell lung cancer (NSCLC).
Alecensa is an oral medication that inhibits the anaplastic enzyme lymphoma kinase (ALK). Anaplastic refers to cells that do not become the correct type of cell as they mature, instead they become cancerous. ALK plays an important role in development, particularly in nervous system cells. Unfortunately, the ALK is some cases becomes incorrectly activated and induces cancer development.
Chugai, a drug manufacturer operating in Japan controlled by the pharmaceutical company Hoffmann–La Roche, conducted the J-ALEX study. It was an open-label, randomized Phase 3 clinical trial assessing Alecensa versus crizotinib in Japan. Participants were 207 ALK-positive patients with advanced or recurrent NSCLC who did not previously take an ALK inhibitor. Approximately half of the study participants received Alecensa; the others received crizotinib therapy.
The researchers found that Alecensa reduced disease worsening risk or death by 66% compared to crizotinib. People taking Alecensa experienced fewer side effects compared to people taking crizotinib. The safety of Alecensa was similar to what has been measured in previous studies.
“This is the first investigational study to show Alecensa helped people live longer without their disease getting worse compared to crizotinib,” Dr. Sandra Horning, chief medical officer and head of Global Product Development, said in a press release. “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.”
Genentech will make the first official presentation of the data June 6 at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, Ill. Approximately 30,000 cancer research and treatment professionals are expected to attend.
Alecensa received accelerated U.S. Food and Drug Administration (FDA) approval in December 2015 to treat ALK-positive NSCLC that had progressed or in people who cannot tolerate crizotinib.
Another Phase 3 study called ALEX, will compare Alecensa to crizotinib as a first-line treatment for patients diagnosed with advanced NSCLC and ALK-positive tumors. ALK-positivity was diagnosed using a test developed by Roche Tissue Diagnostics, known as VENTANA ALK (D5F3) CDx Assay immunohistochemistry (IHC) .