Alecensa Fails to Improve Survival in Lung Cancer Subset

Patients with treatment-naive, advanced ALK-positive non-small cell lung cancer failed to achieve a survival benefit after receiving treatment with Alecensa (alectinib), compared to Xalkori (crizotinib), according to the final analysis of study results.

However, the data, which were presented during the 2021 American Society of Clinical Oncology Annual Meeting, may be confounded since 78.8% of patients who received Alecensa received Xalkori initially.

In the primary analysis of the phase 3 randomized, open-label J-ALEX study, Alecensa demonstrated better progression-free survival (or time that a patient lives with cancer without disease worsening) than Xalkori. In fact, median progression-free survival was not reached with Alecensa, compared to 10.2 months with Xalkori. Additional findings from a data cut-off in June 2018 continued demonstrating better progression-free survival for Alecensa than Xalkori. In the final analysis, investigators sought to examine overall survival data after a minimum of five years of follow up.

“In this final analysis, from J-ALEX, prolongation of (overall survival) in the (Alecensa group) was not observed compared to (Xalkori,” said study author Dr. Hiroshige Yoshioka, of Kansai Medical University Hospital in Japan, in a presentation of the findings. “However, median (overall survival) was not reached in either treatment arm. This (overall survival) result may have been confounded by crossover.”

Patients were randomized 1:1 to receive either Alecensa (300 mg twice daily) or Xalkori (250mg twice daily) until disease progressed, unacceptable toxicity was reached, withdrawal or death. Treatment crossover between groups was permitted after withdrawal.

At a median follow-up of 68.6 months in the Alecensa group and 68 months in the Xalkori group, deaths occurred in 40.8% and 39.4% of patients, respectively. Five-year survival rates for Alecensa-treated patients were 60.85% compared to 64.11% in Xalkori-treated patients.

Yoshioka concluded noting that this data should be taken into consideration in the global ALEX study. In this study, the use of Alecensa administered twice a day has been associated with an overall survival improvement compared to Xalkori in treatment-naive, advanced ALK-positive NSCLC.

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