Roche's Alecensa (alectinib) significantly reduced the risk of disease worsening or death as first-line treatment in Asian patients with ALK-positive advanced or metastatic non-small cell lung cancer

F. Hoffmann-La Roche Ltd / Roche's Alecensa (alectinib) significantly reduced the risk of disease worsening or death as first-line treatment in Asian patients with ALK-positive advanced or metastatic non-small cell lung cancer . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.

• Head-to-head phase III study of Alecensa versus crizotinib in Asian patient population showed a reduction in the risk of disease worsening or death by 78%

Alecensa lowered the risk of tumour spread or growth in the brain or central nervous system by 86%

Data add to a wealth of evidence, including the phase III ALEX and J-ALEX studies, supporting first-line use of Alecensa in multiple patient populations within ALK-positive non-small cell lung cancer and rapid worldwide regulatory approvals

Basel, 22 October 2018 - Roche (SIX: RO, ROG; OTCQX: RHHBY) will today announce results from the phase III ALESIA study, showing that Alecensa (alectinib) met its primary endpoint of investigator-assessed (INV) progression-free survival (PFS). Alecensa significantly reduced the risk of disease worsening or death by 78%, compared to crizotinib, when given as an initial (first-line) monotherapy treatment in Asian patients with anaplastic lymphoma kinase (ALK)-positive advanced or metastatic non-small cell lung cancer (NSCLC) (hazard ratio [HR]=0.22, 95% CI: 0.13-0.38).[1] Median PFS reported by the investigators was not yet reached in patients who received Alecensa (95% CI: 20.3 months-not reached) versus 11.1 months (95% CI: 9.1-13.0 months) in those who received crizotinib.^[1] The safety profile of Alecensa was consistent with that observed in previous studies. [1]

"The ALESIA study supports the use of Alecensa as the standard of care for newly diagnosed advanced or metastatic ALK-positive lung cancer across multiple populations," said Sandra Horning, MD, Roche's Chief Medical Officer and Head of Global Product Development. "Alecensa has received rapid regulatory approvals for first-line treatment in 65 countries to date, including in China."

Median PFS reported by an independent review committee (IRC), a secondary endpoint, was not yet reached in patients who received Alecensa (95% CI: 16.7 months-not reached), versus 10.7 months (95% CI: 7.4 months-not reached) in patients who received crizotinib (HR=0.37, 95% CI: 0.22-0.61). [1] The phase III ALESIA study also demonstrated that compared to crizotinib, Alecensa reduced the risk of disease progression in the central nervous system (CNS), another secondary endpoint in the study, by 86% (HR=0.14, 95% CI: 0.06-0.30). [1]