Phase III study shows significant benefit of Alecensa in ALK-positive lung cancer

Swiss pharma giant Roche (ROG: SIX) today announced results from the global Phase III ALUR study showing that Alecensa (alectinib) significantly reduced the risk of disease worsening or death (progression-free survival, PFS) by 85% compared to chemotherapy in patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC), who had progressed following treatment with platinum-based chemotherapy and Pfizer’s (NYSE: PFE) Xalkori (crizotinib) (hazard ratio [HR]=0.15, 95% CI: 0.08-0.29, p<0.001).

Median PFS reported by the investigators, the primary endpoint of the study, was 9.6 months in patients who received Alecensa (95% CI: 6.9-12.2) compared with 1.4 months (95% CI: 1.3-1.6) in those who received chemotherapy (pemetrexed or docetaxel). Median PFS assessed by an independent review committee (IRC), a secondary endpoint, was 7.1 months for patients who received Alecensa versus 1.6 months for patients who received chemotherapy (HR=0.32, 95% CI 0.17–0.59; p<0.001). The safety profile of Alecensa was consistent with that observed in previous studies and compared favourably to chemotherapy.

“The strikingly positive results from the ALUR study across multiple endpoints provide strong further evidence of the efficacy of Alecensa in this setting,” said Sandra Horning, Roche’s chief medical officer and head of global product development, adding: “We believe this robust data will support access to Alecensa for patients with ALK-positive lung cancer.”

The ALUR data will be presented at the European Society for Medical Oncology (ESMO) 2017 Congress on September 11, 2017.

The Phase III ALUR study also demonstrated: