Business Wire

EU Follows US and Approves Chugai's ALK Inhibitor "Alecensa®" as First Line Therapy for ALK-Positive Non-Small Cell Lung Cancer

Del

Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced today that F. Hoffmann-La Roche Ltd. obtained approval from the European Commission, for Alecensa® as monotherapy indicated for “the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)”. In addition, the EU marketing authorisation for Alecensa has been switched from conditional approval (given in February 2017) to a full approval for the treatment of people with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib (second-line).

"Following approval for first line treatment in the US in November 2017, it is a great pleasure for Chugai that Alecensa has been approved for primary treatment in the EU. An improvement in prognosis is expected in patients with ALK-positive advanced NSCLC who receive treatment with Alecensa at an early stage,” said Dr. Yasushi Ito, Chugai’s Senior Vice President, Head of Project & Lifecycle Management Unit. “In addition to the J-ALEX study (JapicCTI-132316) conducted in Japan, results of the ALEX study (NCT02075840) conducted overseas also showed that this will be great news for patients. We are convinced that Alecensa can contribute to the treatment of many patients in the world."

This additional approval is based on results from the phase III ALEX study (NCT02075840).
The ALEX study (NCT02075840) evaluates the efficacy and safety of Alecensa compared with crizotinib in people with ALK-positive NSCLC who had not received prior systemic therapy (first-line). In the study, Alecensa significantly reduced the risk of disease worsening or death by 53% (HR=0.47, 95%CI: 0.34-0.65, stratified log-rank test, p<0.001) compared to crizotinib as assessed by investigators. Median progression-free survival (PFS) was 25.7 months (95%CI: 19.9-not estimable) for people who received Alecensa compared with 10.4 months (95%CI: 7.7-14.6) for people who received crizotinib as assessed by independent review committee. The safety profile of both drugs was consistent with that observed in previous studies, with no new findings.

In addition, Alecensa significantly reduced the risk of the cancer spreading to or growing in the brain or central nervous system (CNS) compared to crizotinib by 84% (HR=0.16, 95%CI: 0.10-0.28, stratified log-rank test, p<0.001). This was based on a time to CNS progression analysis in which there was a lower risk of progression in the CNS as the first site of disease progression for people who received Alecensa (12%) compared to people who received crizotinib (45%).

About Alecensa

Alecensa is a highly selective oral ALK inhibitor discovered by Chugai. It has been reported that approximately five percent of patients with NSCLC express a chromosomal rearrangement which leads to fusion of the ALK gene with another gene.1) ALK kinase signalling is constantly active in cells with such fusion genes, resulting in uncontrolled growth of tumour cells and transforming the cells into tumour cells.2, 3) Alecensa exerts its anti-tumour effect by selectively inhibiting ALK kinase activity to inhibit tumour cell proliferation and induce cell death.4) In addition, Alecensa is not recognized by the active efflux system in the blood brain barrier which actively pumps molecules out of the brain. Alecensa is able to remain active in the central nervous system and has proven activity against brain metastases.

Outside of Japan, Alecensa is currently approved in the United States, Europe, Kuwait, Israel, Hong Kong, Canada, South Korea, Switzerland, India, Australia, Singapore, Taiwan, Thailand, Liechtenstein, Argentina, United Arab Emirates, Saudi Arabia and Turkey for the treatment of people with metastatic (advanced) ALK-positive NSCLC whose disease has worsened after, or who could not tolerate treatment with, crizotinib and in the US, EU and Turkey for the treatment of first line therapy on ALK-positive metastatic NSCLC.

In Japan, Alecensa is available to patients with “ALK fusion gene positive unresectable, recurrent/advanced NSCLC” and is marketed by Chugai. The approved dosage and administration in Japan is "300mg alectinib administered orally twice daily for adult patient."

 
1)   Biomarker committee of The Japan Lung Cancer Society, Guidelines for ALK gene tests in lung cancer patients
2) Soda et al., Nature. 448: 561-566 (2007)
3) Takeuchi et al., Clin Cancer Res. 15: 3143-3149 (2009)
4) Sakamoto et al., Cancer Cell. 19: 679-690 (2011)
 
Note:   The dosage and administration of the ALEX study is "600mg alectinib administered orally twice daily," which is different from the Japanese dosage and administration.
 

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.
In Japan, Chugai’s research facilities in Gotemba and Kamakura are collaborating to develop new pharmaceuticals and laboratories in Ukima are conducting research for technology development for industrial production. Overseas, Chugai Pharmabody Research based in Singapore is engaged in research focusing on the generation of novel antibody drugs by utilizing Chugai’s proprietary innovative antibody engineering technologies. Chugai Pharma USA and Chugai Pharma Europe are engaged in clinical development activities in the United States and Europe.
The consolidated revenue in 2016 of Chugai totalled 491.8 billion yen and the operating income was 80.6 billion yen (IFRS Core basis).
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.

Contact information

For Media
Chugai Pharmaceutical Co., Ltd.
Media Relations Group, Corporate Communications Dept.,
Koki Harada
Tel: +81-3-3273-0881
E-mail: pr@chugai-pharm.co.jp
***
For US media
Chugai Pharma USA Inc.
Paul Mignone
Tel: +1-908-516-1350
E-mail: pr@chugai-pharm.com
***
For European media
Chugai Pharma France SAS
Nathalie Leroy
Tel: +33-1-56-37-05-21
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

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

PSE: APM Forum 2018 Focus on Digitalisation for the Process Industries20.4.2018 15:13Pressemelding

At the 2018 Advanced Process Modelling (APM) Forum this week, process industry organisations presented on digital design and operations applications ranging from accelerating development of the next generation of pharmaceuticals to realising millions of dollars per year in increased profit for large process plants. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180420005517/en/ Ben Weinstein, head of R&D Product and Process Systems Modeling at Procter & Gamble, delivers the keynote speech on how digital design techniques are used systematically to accelerate innovation in P&G. (Photo: Business Wire) Introducing the conference, Prof. Costas Pantelides, MD of conference host Process Systems Enterprise (PSE), described the current wave of digitalisation as the culmination of many years of advanced modelling and IT development. “This is a time of extraordinary opportunities for the process industries” he said. Keynote speaker Ma

Aperta Provides Electronic Funds Transfer (EFT) in Cayman Islands20.4.2018 14:01Pressemelding

Once again, the Aperta Active Clearing System (ACS) has delivered the mechanism for a country to implement a world-class electronic payment processing environment to maximize a national payments system’s efficiency, effectiveness, security and control. Aperta partnered with the Cayman Islands ACH Operator (Prism Services (Cayman) Ltd.) and local commercial banks to deliver a new Electronic Funds Transfer system. The old process of banks swapping files in a wide-variety of standards and settling bilaterally has been replaced with a common system and standards, employing international-standard secure file transfer protocol, allowing participants to monitor real time net settlement and collateral positions via a secure portal. The Cayman Islands Automated Clearinghouse (CIACH) links all six of the country’s banks and provides the central clearing and settlement mechanism for banks to exchange direct debit and direct credit transactions seamlessly across the country. It is functionally NAC

FII Tech Growth Invests in SECO20.4.2018 13:39Pressemelding

FII Tech Growth, a fund managed by Fondo Italiano d’Investimento SGR, announces today its second investment in SECO SpA, one of the European leaders in the embedded electronics market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180420005413/en/ (Photo: SECO) SECO, headquartered in Arezzo, Tuscany, with subsidiaries in the U.S.A., Germany and Taiwan, was founded in 1979 by entrepreneurs Daniele Conti and Luciano Secciani. The company designs and manufactures micro-computers and integrated systems for industrial applications. With more than 250 employees, SECO supports customers with a worldwide presence such as Cimbali, Esaote, Technogym and Vimar, and generated revenue in excess of Euro 50 million in 2017. The ability to offer innovative solutions by using cutting-edge technologies has allowed SECO to grow steadily over time. The company developed a network of collaborations with universities and research centres La Sapi

Schlumberger Announces First-Quarter 2018 Results20.4.2018 11:05Pressemelding

Schlumberger Limited (NYSE:SLB) today reported results for the first quarter of 2018. (Stated in millions, except per share amounts) Three Months Ended Change Mar. 31, 2018 Dec. 31, 2017 Mar. 31, 2017 Sequential Year-on-year Revenue $7,829 $8,179 $6,894 -4% 14% Pretax operating income $974 $1,155 $757 -16% 29% Pretax operating margin 12.4% 14.1% 11.0% -169 bps 145 bps Net income (loss) - GAAP basis $525 $(2,255) $279 n/m 88% Net income, excluding charges & credits* $525 $668 $347 -21% 51% Diluted EPS (loss per share) - GAAP basis $0.38 $(1.63) $0.20 n/m 90% Diluted EPS, excluding charges & credits* $0.38 $0.48 $0.25 -21% 52% *These are non-GAAP financial measures. See section below entitled "Charges & Credits" for details. n/m = not meaningful Schlumberger Chairman and CEO Paal Kibsgaard commented, “As forecast, our results in the first quarter of 2018 largely reflected transitory factors, with seasonal reductions in activity in the Northern Hemisphere and planned project startup costs

Biogen and Ionis Expand Strategic Collaboration to Develop Drug Candidates for a Broad Range of Neurological Diseases20.4.2018 10:30Pressemelding

Biogen (Nasdaq: BIIB) and Ionis Pharmaceuticals (Nasdaq: IONS) announced today they have expanded their strategic collaboration through a new ten-year collaboration agreement to develop novel antisense drug candidates for a broad range of neurological diseases. This collaboration capitalizes on Biogen’s expertise in neuroscience research and drug development and Ionis’ leadership in RNA targeted therapies with the goal of developing a broad pipeline of investigational therapies. It builds upon a productive collaboration that produced SPINRAZA, the first and only approved treatment for patients with spinal muscular atrophy. Today, April 20, 2018, Biogen and Ionis will host company conference calls and webcasts to discuss the new collaboration. Full webcast details can be found below. Under the terms of the collaboration, Biogen will pay Ionis $1 billion in cash, which will include $625 million to purchase 11,501,153 shares of Ionis common stock at a price of $54.34 per share, at an appr

Versum Materials Celebrates the Grand Opening of Its Research and Development Facility in Hometown, PA19.4.2018 20:37Pressemelding

Versum Materials, Inc. (NYSE: VSM), a leading materials supplier to the semiconductor industry, announced today the grand opening of its new research and development (R&D) facility at its semiconductor materials manufacturing site in Hometown, Pennsylvania. The ribbon-cutting ceremony took place April 10, 2018. Versum employees, members of the community, local government, customers and strategic partners attended the event. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180419006305/en/ Versum Materials ribbon-cutting ceremony at the company's new R&D facility in Hometown, PA. (Photo: Business Wire) The state-of-the-art R&D laboratory is dedicated to new materials used in the manufacture of semiconductors. Scientists in the facility will synthesize and purify new molecules down to parts per billion impurity levels and below using the latest technologies available in the industry. The researchers can assess the applications f