Final Progression-Free Survival Data and the Second Interim Analysis of Overall Survival from the J-ALEX Study for Alecensa Presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting

On June 3, 2019 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that the final progression-free survival (PFS) data and the second interim analysis of overall survival (OS) from the Japanese phase III J-ALEX study for Alecensa were presented on June 2 (local time) at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place from May 31 to June 4 in Chicago, IL, United States (Press release, Chugai, JUN 3, 2019, View Source [SID1234536782]). J-ALEX study compared Alecensa and crizotinib as the first-line treatment for patients with ALK fusion gene positive non-small cell lung cancer (NSCLC).

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Abstract #9092;
Final PFS analysis and safety data from the phase III J-ALEX study of Alectinib (ALC) vs. Crizotinib (CRZ) in ALK-inhibitor naïve ALK-positive Non-Small Cell Lung Cancer (ALK+NSCLC)

"The long-term data from the J-ALEX study confirms the benefits of Alecensa as the first-line treatment for patients with ALK-positive NSCLC," said Dr. Yasushi Ito, Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management Unit.

The J-ALEX study is an open-label, randomized phase III study that compares the efficacy and safety between Alecensa and crizotinib. The J-ALEX study enrolled 207 ALK-inhibitor naïve patients with ALK fusion gene positive advanced or recurrent NSCLC, who either had not undergone chemotherapy or had undergone one chemotherapy regimen. The primary endpoint of the J-ALEX study was PFS as assessed by an independent review facility (IRF). The secondary endpoints included OS, time to disease progression of brain metastases in patients with brain metastases at baseline, and safety.

In February, 2016, Chugai carried out a prospectively defined interim analysis, and had an independent data monitoring committee examine the results. Since the results showed that Alecensa significantly prolonged PFS to a higher extent than anticipated, the committee decided to recommend an early discontinuation of the study [Alecensa arm: not estimable (95% CI: 20.3-not estimable), crizotinib arm: 10.2 months (95% CI: 8.2-12.0), HR=0.34 (99.7% CI: 0.17-0.70), stratified log-rank test, p<0.0001)].

Latest data from the J-ALEX study shows:

Risk of progression or death was reduced by 63% (HR=0.37, 95% CI: 0.26-0.52) in the Alecensa arm compared to the crizotinib arm. Median PFS (primary endpoint) was 34.1 months in the Alecensa arm (95% CI: 22.1-not estimable) versus 10.2 months (95% CI: 8.3-12.0) in the crizotinib arm.
In the second interim analysis, the superiority of OS in the Alecensa arm over the crizotinib arm was not conclusive (stratified HR=0.80, 95% CI: 0.35-1.82). The investigation on OS will be continued.
The safety profile of Alecensa was consistent with previous reports.
[Reference information]
Media release issued by Chugai on May 11, 2017:
Results of the J-ALEX Study for Chugai’s Alecensa are Published in "The Lancet" Online;
View Source