IL-CHUGAI-PHARMACEUTICAL
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
Hanseo University Expands Aviation Training Program with New Frasca Flight Training Device10.12.2025 16:05:00 CET | Press release
The new device marks the latest milestone in a long-standing collaboration between Hanseo University and Frasca International, Inc. Frasca International, Inc., a FlightSafety International company and leader in flight simulation, today announced that Hanseo University in South Korea is expanding its aviation program with a new Level 5 Cessna 172 Flight Training Device (FTD), the seventh Frasca device to join the university’s fleet. Hanseo University’s school of Aeronautical Science recognized by the Korean University Accreditation Institute as the nation’s first Specialized University for Training Professional Workforce Industries, continues to expand its state-of-the-art simulation capabilities with the acquisition of a Level 5 Cessna 172 FTD. The addition builds on a partnership with Frasca that has spanned more than two decades and further advances aviation education across Asia. “We were seeking simulators that provided both realism and reliability, and Frasca stood out immediately
Bregal Milestone Announces Majority Growth Investment in Beyond Now10.12.2025 16:00:00 CET | Press release
Partnership to Drive Beyond Now’s AI-Led Innovation and Expansion Bregal Milestone, a leading European software growth private equity firm, today announced a majority growth investment in Beyond Now (the “Company”), a fast-growing, cloud-native supply chain software provider for AI-enabled digital commerce. Driven by strong customer demand, Beyond Now has generated profitable growth and >40% last twelve-month ARR growth. Beyond Now supports some of the world’s largest and most innovative Communication Service Providers (CSPs), including Verizon, AT&T, Deutsche Telekom, and NTT, in managing complex digital supply chains to create seamless end-to-end partner and customer operations. Founded in 2018, the Company serves telecommunication providers, technology companies, and private enterprises to efficiently scale and monetize digital services through its suite of modern, Ecosystem Orchestration and Digital Platforms - including an AI Digital Business Platform for orchestrating partner off
NetJets to Bring Starlink High-Speed Connectivity to Fleet10.12.2025 15:05:00 CET | Press release
The agreement between the two companies will bring reliable Wi-Fi connectivity to one of the world’s largest fleets of jets, ensuring a seamless, best-in-class experience for Owners NetJets, the global leader in private aviation, and Starlink have entered into an agreement to bring high-speed in-flight connectivity to 600 aircraft across NetJets’ global fleet by the end of 2026, unlocking a new level of productivity and exceptional travel experiences in the air. “This agreement with Starlink positions NetJets to continue delivering exceptional travel experiences for our Owners and their guests,” said Patrick Gallagher, President, NetJets Aviation. “With Starlink, travel is elevated with reliable connectivity whether our Owners are flying for business or leisure—as seamless connectivity is critical to the experience our Owners need and deserve.” This multi-year, service level agreement paves the way for NetJets to quickly and seamlessly outfit its aircraft across the U.S. and Europe, wi
Mercator Ocean International Makes AI Ocean Forecasting Operational with GLONET Validated by OceanBench at NeurIPS 202510.12.2025 15:00:00 CET | Press release
New benchmark sets the first science-based quality standard for AI ocean models, enabling GLONET’s operational deployment At NeurIPS 2025, one of the world’s leading AI conferences, Mercator Ocean unveiled OceanBench, the first open benchmark designed to assess AI Ocean forecasting models. This milestone follows the publication of Mercator Ocean’s AI model GLONET in September. Together, OceanBench and GLONET represent a decisive step toward integrating artificial intelligence into operational ocean forecasting, strengthening Europe’s leadership in trustworthy, AI-driven predictions at global scale. Presented by Anass El Aouni, Oceanographer and machine learning (ML) researcher, and Quentin Gaudel, ML Systems Architect, OceanBench establishes a unified standard to evaluate AI models against fundamental ocean dynamics. GLONET is the first forecasting system to be validated through OceanBench for operational use. Anass El Aouni : “OceanBench provides a transparent standard to evaluate AI-
Cleveland Clinic Neurological Institute and Baszucki Group Team Up to Advance Landmark Brain Study with Metabolic Health Markers10.12.2025 15:00:00 CET | Press release
The collaboration seeks to study gut-brain connections in neurological disorders Baszucki Group today announced an expanded commitment to the landmark Cleveland Clinic Brain Study. Launched in 2022, this ambitious longitudinal study plans to follow healthy individuals over a 20-year period with the goal of identifying early disease markers and therapeutic targets needed to prevent and ultimately cure neurological diseases. The commitment from Baszucki Group brings their total donation to the study to $450,000. The commitment was announced at Keep Memory Alive’s annual Summer Festival & Rodeo at Shakespeare Ranch in Glenbrook, Nevada, an event benefiting the Lou Ruvo Center for Brain Health and hosted by Larry and Camille Ruvo, co-founders of Keep Memory Alive. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251208681513/en/ Baszucki Group and Cleveland Clinic Neurological Institute expand impact of landmark brain study to inv
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