Patients with non-small cell lung cancer (NSCLC) have a high risk of central nervous system and brain metastases.

In a head-to-head study with Pfizer’s crizotinib (Xalkori), Roche’s cancer drug alectinib (Alecensa) has shown a far lower risk of cancer spreading to the brain in patients with advanced ALK-positive NSCLC.

New results from the ALEX trial, along with data from the Phase III ALUR trial, will be presented at the European Society for Medical Oncology (ESMO) congress in Madrid. 

In a new subgroup analysis of the Phase III study ALEX, alectinib reduced the risk of disease progression in the central nervous system by 60 percent compared with crizotinib in patients who had existing metastases in the central nervous system. 

In patients without brain disease at the start of testing, alectinib reduced the risk of disease progression in the central nervous system by 49 percent.

In the ALUR study, data showed an 85 percent reduction in risk of disease worsening or death versus chemotherapy in patients who had previously seen their disease worsen on chemotherapy and crizotinib.

ALUR included 107 ALK-positive NSCLC patients whose disease had progressed after a previous first-line combination treatment of both platinum-based chemotherapy and crizotinib.

Patients were randomized to second-line therapy with either standard relapse chemotherapy or alectinib.

Median progression free survival (PFS) was significantly longer in the alectinib group compared to the chemotherapy group—9.6 months versus 1.4 months.

Among patients who had measurable CNS disease at baseline, the central nervous system overall response rate was 54.2 percent in those treated with alectinib compared to zero in the chemotherapy group.

The safety profile of alectinib compared favorably with chemotherapy, despite the substantially longer 20-week duration of treatment for patients on alectinib compared to six weeks with chemotherapy.

“This is another important goal reached in the field of thoracic oncology,” said study investigator Dr. Silvia Novello, University of Turin, Italy. “ALK- positive patients represent 4 percent of patients with advanced NSCLC, which is the leading cause of solid cancer deaths in men and women in several countries. Central nervous system data are extremely relevant for these patients – the brain is a frequent site of metastasis for them – and these results are important because if we’re aiming to prolong survival we must aim to preserve their neurocognitive capacity. A drug which has this activity on brain metastases can allow us to modify treatment and reduce the need for whole brain radiotherapy.”