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Alecensa for ALK-Positive Lung Cancer: Priority Review For Treatment

from Business Wire
  • Second positive Phase III head-to-head study to show Alecensa was superior to crizotinib in people with ALK-positive lung cancer
  • Alecensa lowered the risk of tumor spread or growth in the brain or central nervous system
  • Data will be simultaneously published in the New England Journal of Medicine and featured in the official ASCO press program

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III ALEX study showed Alecensa® (alectinib) significantly reduced the risk of disease worsening or death (progression-free survival, PFS) by more than half (53 percent) compared to crizotinib when given as initial (first-line) treatment for people with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) (hazard ratio [HR]=0.47, 95 percent CI: 0.34-0.65, p<0.0001). Median PFS reported by the investigators, the primary endpoint of the study, was not yet reached in people who received Alecensa (95 percent CI: 17.7-not reached) versus 11.1 months (95 percent CI: 9.1-13.1 months) in those who received crizotinib. Median PFS assessed by an independent review committee (IRC), a secondary endpoint, was 25.7 months (95 percent CI: 19.9-not reached) for people who received Alecensa versus 10.4 months (95 percent CI: 7.7-14.6 months) for people who received crizotinib (HR=0.50, 95 percent CI: 0.36-0.70, p<0.0001). The safety profile of Alecensa was consistent with that observed in previous studies.

“Alecensa reduced the risk of disease progression by more than half and reduced the risk of cancer spreading to or growing in the brain, which can have devastating effects for patients,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “These results significantly improve upon the standard of care for this disease, extending the average time that people lived without their disease worsening from less than a year to more than two years. We are submitting these data to regulatory authorities around the world.”

The global, randomized Phase III ALEX study also demonstrated that Alecensa reduced the risk of disease progression in the central nervous system (CNS) by 84 percent (HR=0.16, 95 percent CI: 0.10-0.28, p<0.0001). The 12-month cumulative rate of CNS progression for people with or without existing CNS metastases at baseline was 9.4 percent (95 percent CI: 5.4-14.7 percent) for people treated with Alecensa and 41.4 percent (95 percent CI: 33.2-49.4 percent) for people treated with crizotinib.

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