Roche reports detailed Phase III data for Alecensa in previously treated NSCLC

Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit reported additional data from the Phase III ALUR trial in 107 patients with non-small cell lung cancer (NSCLC) showing that twice-daily 600 mg oral Alecensa alectinib (AF802, CH5424802, RG7853, RO5424802) led to a median progression-free survival (PFS) as assessed by investigators, the primary endpoint, of 9.6 months vs. 1.4 months for chemotherapy with pemetrexed or docetaxel (p<0.001). Median PFS as assessed by an independent review committee was 7.1 months for Alecensa vs. 1.6 months for chemotherapy (p<0.001).

On secondary endpoints, Alecensa led to an overall response rate (ORR) and a CNS ORR of 36.1% and 54.2%, respectively, vs. 11.4% and 0% for chemotherapy. Median duration of response was 9.3 months for Alecensa vs. 2.7 months for placebo. The trial enrolled patients with anaplastic lymphoma kinase (ALK)-positive advanced NSCLC who progressed following treatment with 1 prior line of both platinum-based chemotherapy and Xalkori crizotinib. Data were presented at the European Society for Medical Oncology meeting in Madrid...