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Roche’s Alecensa shows significant effect over Pfizer’s Xalkori to treat ALK- positive NSCLC

PBR Staff Writer Published 11 April 2017

A phase III study has revealed that Roche’s Alecensa (alectinib) showed significant effect over Pfizer’s Xalkori (crizotinib) in the treatment of patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

The global and randomised phase III ALEX study met its primary endpoint, demonstrating that Alecensa as an initial (first-line) treatment has decreased the risk of disease worsening or death compared against crizotinib in people with ALK- positive NSCLC.

The current trial is the second study to demonstrate that Alecensa is effective as an initial treatment compared against in this type of lung cancer.

ALEX is a randomised, multicentre and open-label phase III study, which assessed the efficacy and safety of Alecensa against crizotinib in treatment-naïve people with ALK-positive NSCLC whose tumours were characterised as ALK-positive by the Ventana ALK (D5F3) CDx assay.

Created at Chugai Research Laboratories, Alecensa is an oral medicine that is being developed for people with NSCLC whose tumours are identified as ALK-positive.

Currently, Alecensa has secured approval in the US, , Europe, Kuwait, Israel, Hong Kong, Canada, South Korea, Switzerland, India, Australia and Taiwan to treat advanced (metastatic) ALK-positive NSCLC.

In September 2016, the firm secured breakthrough therapy status for Alecensa to treat people with advanced ALK-positive NSCLC who have not received prior treatment with an ALK inhibitor.

Last February, Alecensa secured conditional marketing authorization for Alecensa in the European Union as a monotherapy to treat people with ALK-positive NSCLC previously treated with crizotinib

Roche Group’s member Chugai Pharmaceutical markets Alecensa in Japan.

Roche chief medical officer and global product development head Dr Sandra Horning said: “Our goal is to transform the standard of care and we are excited to share these results with the lung cancer community.”

“As part of its Breakthrough Therapy Designation, we hope to bring Alecensa as an initial treatment for people with ALK-positive NSCLC as soon as possible and will discuss these data with global health authorities.”


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