Study: Roche's Alecensa significantly improves PFS versus Pfizer's Xalkori in ALK-positive lung cancer

Roche's Genentech unit announced Monday new data from the Phase III ALEX study, showing that Alecensa (alectinib) as a first-line treatment for patients with ALK-positive non-small-cell lung cancer (NSCLC) reduced the risk of disease worsening or death by 53 percent when compared with Pfizer's Xalkori (crizotinib). The Swiss drugmaker noted that median progression-free survival (PFS) reported by the investigators, the primary goal of the trial, was not yet reached in people who received Alecensa, versus 11.1 months for Xalkori.

In April, Roche reported that the study met its primary endpoint, with the oral ALK inhibitor significantly reducing the risk of disease worsening or death compared to Xalkori. The Swiss company added Monday that median PFS as assessed by an independent review committee, a secondary goal, was 25.7 months for patients given Alecensa versus 10.4 months for Pfizer's drug.

The trial randomised 303 treatment-naïve people with ALK-positive NSCLC to receive either Alecensa or Xalkori. Other secondary endpoints include time to central nervous system progression, objective response rate, duration of response, overall survival, health-related quality of life and safety.

Results detailed on Monday at the ASCO annual meeting also showed that Alecensa reduced the risk of disease progression in the central nervous system (CNS) by 84 percent. Genentech said that the 12-month cumulative rate of CNS progression for people with or without existing CNS metastases at baseline was 9.4 percent for those treated with Alecensa and 41.4 percent for Pfizer's drug. In addition, Grade 3-5 adverse events were less frequent in the Alecensa arm at 41 percent, compared to 50 percent in the Xalkori arm.

Sandra Horning, Roche's chief medical officer, remarked "these results significantly improve upon the standard of care for this disease, extending the average time that people lived without their disease worsening from less than a year to more than two years." Horning added "we are submitting these data to regulatory authorities around the world."

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Last year, Roche announced that Alecensa reduced the risk of disease worsening or death by 66 percent compared to Xalkori in Japanese people with advanced or recurrent, ALK-positive NSCLC. At the time, the company noted that median PFS was not reached in people who received Alecensa versus 10.2 months median PFS for Xalkori. For related analysis, see ViewPoints: Can Roche's Alecensa deliver on its eastern promise?

The therapy, 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.

Sales of Alecensa reached 182 million Swiss francs ($189 million) last year, while Xalkori generated revenue of $145 million.

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