IL-CHUGAI-PHARMACEUTICAL
3.6.2019 08:02:10 CEST | Business Wire | Press release
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) Annual Meeting, taking place from May 31 to June 4 in Chicago, IL, United States. 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).
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;
https://www.chugai-pharm.co.jp/english/news/detail/20170511113001_82.html
About Chugai
Chugai Pharmaceutical is one of Japan’s leading research-based pharmaceutical companies with strengths in biotechnology products. Chugai, based in Tokyo, specializes in prescription pharmaceuticals and is listed on the 1st section of the Tokyo Stock Exchange. As an important member of the Roche Group, Chugai is actively involved in R&D activities in Japan and abroad. Specifically, Chugai is working to develop innovative products which may satisfy the unmet medical needs, mainly focusing on the oncology area. Additional information is available on the internet at https://www.chugai-pharm.co.jp/english .
Trademarks used or mentioned in this release are protected by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190602005114/en/
Contact:
For Media Chugai Pharmaceutical Co., Ltd. Media Relations Group, Corporate Communications Dept., Tomoko Shimizu Tel: +81-3-3273-0881 E-mail: pr@chugai-pharm.co.jp
For US media Chugai Pharma USA Inc. Casey Astringer Tel: +1-908-516-1350 E-mail: pr@chugai-pharm.com
For European media Chugai Pharma U.K. Ltd. Carter Westwood Tel: +44-20-8987-5680 E-mail: pr@chugai.eu
For Taiwanese media Chugai Pharma Taiwan Ltd. Susan Chou Tel: +886-2-2715-2000 E-mail: pr@chugai.com.tw
For Investors Chugai Pharmaceutical Co., Ltd. Investor Relations Group, Corporate Communications Dept., Toshiya Sasai Tel: +81-3-3273-0554 E-mail: ir@chugai-pharm.co.jp
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Opensignal Crowns the World's Best 5G Networks29.9.2026 10:18:00 CEST | Press release
Annual Global 5G Awards Name Worldwide Winners, Leaders, And Rising Stars from Billions of Real-World User Experiences Opensignal, a global independent consumer connectivity analytics and insights company, today announced its annual Opensignal 5G Global Mobile Network Experience Awards, recognizing the providers delivering the best real-world 5G experiences across their national mobile networks. The awards assess billions of real-world user experiences across Download Speed, Video, Games, Voice App, Reliability, Coverage Experience, and — new for 2026 — Time on 5G, collected between Jan. 1 and June 29, 2026. "The consumer connectivity experience is at the core of everything we do at Opensignal. As the role of 5G in modern life grows, the bar for what great 5G looks like keeps rising," said Shawn Heidel, President, Network Experience at Opensignal. "The best operators in the world are defined by how well they deliver on that challenge, and this year's Global 5G Award winners set the sta
ClickHouse Expands Collaboration With Microsoft, Bringing Fabric Integration, Deeper OneLake Interoperability, and Enterprise Deployment Flexibility29.9.2026 09:30:00 CEST | Press release
ClickHouse, the company behind the open-source, real-time analytical database that has become the data layer for the AI era, today at The European Microsoft Fabric + SQL Community Conference announced a significant expansion of its strategic collaboration with Microsoft. The announcement encompasses four major milestones: the launch of the native ClickHouse workload for Microsoft Fabric, the general availability of OneLake read, the public preview of OneLake write, and the availability of ClickHouse Bring Your Own Cloud (BYOC) in the Microsoft Marketplace. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260929947201/en/ ClickHouse expands collaboration with Microsoft This expansion builds on ClickHouse's growing presence within the Microsoft ecosystem, where data-intensive organizations rely on ClickHouse Cloud on Azure to power real-time observability, business intelligence, AI/ML pipelines, and analytical applications at sc
Opengear Expands Reach Through Pan-European Distribution Agreement with Ingram Micro29.9.2026 09:01:00 CEST | Press release
Opengear’s network resilience solutions now available across 20 European markets Opengear, a Digi International company (NASDAQ: DGII) and global leader in out-of-band management solutions, has signed its first pan-European distribution agreement with Ingram Micro, one of the world’s largest technology distributors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260929668925/en/ Opengear Expands Reach Through Pan-European Distribution Agreement with Ingram Micro The agreement will give resellers in participating Ingram Micro countries access to Opengear’s portfolio, supported by Ingram Micro's regional infrastructure, logistics capabilities and partner network. This expands Opengear’s existing reach in the UK, Ireland, Spain, Germany, Italy, France, Belgium and Luxembourg, and brings its network resilience platform to resellers and end-users in additional European markets, such as Switzerland, Hungary, and Czech Republic. “T
Freemarket and Axiym launch LIQUI-DT™ – real-time business access to primary-market USD₮ from Tether29.9.2026 08:00:00 CEST | Press release
Freemarket and Axiym today launched a world-first service that gives businesses 24/7 real-time access to freshly minted, primary-market USD₮ issued by Tether. LIQUI-DTTM gives businesses compliant access to primary market stablecoins inside a fully regulated payment ecosystem via Freemarket’s global payment network. In audited trials, clients have minted or burned more than $300 million to date. Institutional users and high-volume traders will benefit from superior price certainty and direct liquidity giving them budgetary control. As the USD₮ is minted directly in the primary market, treasury and compliance teams have clear provenance for internal reporting 1. The LIQUI-DT service works because while no single party owns the whole stack, it is integrated into the Freemarket network. The combination of Freemarket’s compliant fiat rails and payment network, Axiym’s liquidity engine and on-chain settlement layer and Tether’s primary market issuance creates a regulated payments network wi
Estonia and Owkin Partner to Advance Sovereign AI in Biology29.9.2026 08:00:00 CEST | Press release
Estonia, led by the National Applied Research Center Metrosert, and Owkin today announced a collaboration to advance sovereign AI in biological and health research, working with Metrosert, Estonia’s state-owned applied research organisation. The collaboration will evaluate how K Pro, Owkin’s AI scientist platform, can help approved researchers work with complex Estonian health data inside secure national infrastructure, enabling reproducible analysis, and faster generation of scientific insight while preserving data sovereignty. The first phase will focus on selected Estonian health-data cohorts, with Owkin and Metrosert also exploring high-value research areas including oncology, where linked clinical, molecular, imaging and treatment-outcome data could support future biomedical research. Estonia has built one of the world’s most advanced digital public infrastructures and holds population-scale health and biomedical data assets. The partnership will explore how these foundations can
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom