Roche's Alecensa bests Pfizer's Xalkori in Phase III study for ALK-positive lung cancer

Roche said Monday that a late-stage study of Alecensa (alectinib) as a first-line treatment for people with ALK-positive advanced non-small-cell lung cancer (NSCLC) met its primary endpoint, with the oral drug significantly reducing the risk of disease worsening or death compared to Pfizer's Xalkori (crizotinib). Sandra Horning, Roche's chief medical officer, remarked "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."

The ALEX trial randomised 303 treatment-naïve people with ALK-positive NSCLC to receive either Alecensa or Xalkori. The study's main goal is progression-free survival (PFS) as assessed by the investigator, while secondary endpoints include: Independent Review Committee-assessed PFS, time to central nervous system progression, objective response rate, duration of response, overall survival, health-related quality of life and safety. Roche noted that full data from the trial will be presented at a future medical meeting.

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Alecensa, which was created by Chugai, is currently approved in the US, Europe, Kuwait, Israel, Hong Kong, Canada, South Korea, Switzerland, India, Australia and Taiwan for the treatment of patients with advanced ALK-positive NSCLC whose disease has worsened after, or who could not tolerate treatment with, Xalkori and in Japan for people with ALK-positive NSCLC. Last year, the FDA granted Alecensa breakthrough therapy designation for the treatment of people with advanced ALK-positive NSCLC who have not received prior treatment with an ALK inhibitor.

In February, the FDA awarded priority review to Novartis' application seeking expanded approval of Zykadia (ceritinib) as a first-line treatment for patients with metastatic NSCLC whose tumours are ALK-positive. For related analysis, read ViewPoints: A priority review for Novartis' Zykadia, but Roche's Alecensa looks poised to reign in ALK-positive NSCLC.


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