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
Empire State Building Observation Deck Run-Up Returns for 48th Annual Race on Oct. 68.7.2026 00:22:00 CEST | Press release
Presented by NYU Langone Health and Powered by MerrellLottery Open Through July 20 The Empire State Building Observation Deck (ESB), atop the “World’s Most Famous Building,” today announced that general lottery registration is open for this year's Empire State Building Observation Deck Run-Up (ESBRU), which will run through July 20, 2026. The annual race, presented by NYU Langone Health and powered by Merrell, will take place on Oct. 6, 2026, at 8 p.m. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260707902561/en/ Empire State Building Observation Deck Run-Up Returns for 48th Annual Race on Oct. 6 This year’s race marks the 48th anniversary of the event, in which 225 runners will race up 1,576 stairs of the iconic New York City landmark to reach the world-famous 86th Floor Observation Deck. “Every year, the Empire State Building Observation Deck Run-Up is a remarkable feat for all who participate as they race up to Tripadvi
Modon's Hudayriyat Golf Estates Sets UAE Record With More Than AED 13 Billion in Sales Within Days of Launch7.7.2026 20:36:00 CEST | Press release
A record-breaking sales value for a residential project in the UAEThe project comprises golf mansions, villas, and townhouses across Hudayriyat Island, Abu Dhabi1,700 residences sold within days after the launch15% non-UAE resident buyers81% new customers to Modon Modon has set a new benchmark for the UAE real estate market with the launch of Hudayriyat Golf Estates on Hudayriyat Island, Abu Dhabi. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260707126559/en/ Modon's Hudayriyat Golf Estates sets UAE record with more than AED 13 billion in sales within days of launch (Photo: AETOSWire) Within days of launch, the community achieved record-breaking sales exceeding AED 13 billion, marking the highest publicly recorded sales value for a single residential project launch in the UAE. Comprising an exclusive collection of golf mansions, villas, and townhouses, the development saw 1,700 of its residences sold after few days of laun
Loomis Sayles Growth Equity Strategies Team Celebrates Twenty-Year Milestones7.7.2026 16:36:00 CEST | Press release
Loomis, Sayles & Company, the century-old investment manager with nearly $418 billion in assets under management, proudly celebrates the 20-year anniversaries of the Loomis Sayles Large Cap Growth and the Loomis Sayles All Cap Growth strategies, as well as a differentiated approach to growth equity investing under the leadership of Aziz V. Hamzaogullari, CFA, the founder, chief investment officer and portfolio manager of the Loomis Sayles Growth Equity Strategies (GES) Team. Aziz is also an executive vice president and a member of the firm’s Board of Directors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260707992418/en/ Celebrating 20 Years of The Power of Active Management Done Right GES is a cohesive team with 20 years of alpha generation and a long-term, private equity approach to investing. Under Aziz Hamzaogullari’s leadership since 2010, assets under management for GES have grown from $1.9 billion to $98.2 billion
Integral Ad Science Appoints Lidiane Jones Chief Executive Officer7.7.2026 15:35:00 CEST | Press release
Accomplished AI and technology executive to lead IAS's next phase of innovation and growth; Lisa Utzschneider to serve as Special Advisor to the Board through year-end Integral Ad Science (IAS), one of the world's most trusted media quality companies, today announced the appointment of Lidiane Jones as Chief Executive Officer, effective immediately. Jones succeeds Lisa Utzschneider, who led IAS for more than seven years and will remain with the company as Special Advisor to the Board through the end of 2026 to support a seamless transition. Utzschneider will also serve as a Special Advisor to Novacap and their portfolio companies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260707780892/en/ Lidiane Jones: Integral Ad Science CEO, Photo Credit: Pamela Hanson The appointment reflects IAS's long-term strategic vision for the future of digital advertising. As AI transforms how media is planned, bought, measured, and optimized
Altasciences and Evidence Matters Advance AI-Driven Drug Development With Nonclinical Automation Breakthrough7.7.2026 15:00:00 CEST | Press release
Altasciences, a fully integrated early-phase drug development organization, and Evidence Matters, a pioneer in clinical trial data science, are pleased to announce a successful proof-of-concept (POC) of RegulatoryFlow (“RegFlow”), following the announcement of the companies’ strategic collaboration in August 2025. The POC demonstrated the extension of AI-driven efficiencies from clinical reporting into nonclinical workflows, marking a significant step forward in accelerating drug development timelines. Building on proven results in clinical reporting, where the collaboration has achieved up to first-draft clinical study reports (CSRs), the teams have now successfully applied similar AI capabilities to nonclinical data through high-quality parsing of raw and SEND datasets in a proof-of-concept. This advancement aligns with the Altasciences Acceleration Platform, designed to fast-track drug development across the early-phase development continuum. “This milestone reflects the power of in
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