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Roche’s lung cancer drug Alecensa shows significant effect in global phase III study

PBR Staff Writer Published 07 September 2017

Roche’s lung cancer drug Alecensa (alectinib) has showed significant effect in the phase III ALUR study.

Alecensa has significantly decreased  the risk of disease deterioration or death (progression-free survival, PFS) by 85% compared against 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 crizotinib.

Alecensa is a selective, CNS active and oral medicine being developed for people with NSCLC whose tumours are identified as ALK-positive.

Alecensa secured approval as a monotherapy for patients with ALK-positive NSCLC who have progressed on or are intolerant to crizotinib in the US, Europe, Kuwait, Israel, Hong Kong, Canada, South Korea, Switzerland, India, Australia, Singapore, Thailand and Taiwan.

ALUR is a randomised, multi-centre and open-label phase III study assessing the efficacy and safety of Alecensa against chemotherapy (pemetrexed or docetaxel) in patients with ALK-positive NSCLC previously treated with one prior line of both platinum-based chemotherapy and crizotinib.

According to the company, the primary endpoint of the ALUR study is PFS and secondary endpoints comprised of overall survival (OS), CNS ORR in patients with measurable brain metastases at baseline and median time to CNS progression.

The company carried out multicentre study in 107 patients across 15 countries.

Roche chief medical officer Dr Sandra Horning said: “The strikingly positive results from the ALUR study across multiple endpoints provide strong further evidence of the efficacy of Alecensa in this setting.

“We believe this robust data will support access to Alecensa for patients with ALK-positive lung cancer.”


Image: Site Roche Basel. Photo: courtesy of F. Hoffmann-La Roche Ltd.