Business Wire

Data of Chugai's Alecensa® Presented at the American Society of Clinical Oncology on Global Phase III ALEX Study

Jaa

Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced today that the results of the global phase III study (the ALEX study) of Alecensa®, conducted by F. Hoffmann-La Roche Ltd., in ALK fusion gene positive non-small cell lung cancer (NSCLC) patients, will be presented at the annual meeting of the American Society of Clinical Oncology (ASCO) held in Chicago. The presentation will be held on oral abstract sessions on 6th June (Tue) 12:09-12:21 (CDT) as a late breaking subject.

Abstract LBA9008
Alectinib versus crizotinib in treatment-naive advanced ALK-positive non-small cell lung cancer (NSCLC): Primary results of the global phase III ALEX study.

“In the ALEX study comparing the efficacy and safety of first line therapy of Alecensa with crizotinib, Alecensa showed a significant prolongation of PFS and reduced the risk of disease progression by 84% in patients with brain metastasis. The study also showed that Alecensa was well tolerated. These results will encourage the patients to fight cancer,” said Dr. Yasushi Ito, Senior Vice President, Head of Project & Lifecycle Management Unit. “We believe that Alecensa will also contribute to improving the outcomes of many ALK fusion gene positive NSCLC patients not just in Japanese but overseas.”

The ALEX study was an open-label, randomized global phase III study that compares the efficacy and safety between Alecensa and crizotinib in the first line therapy. The ALEX study enrolled treatment-naïve 303 patients with ALK fusion gene positive NSCLC. The subjects were allocated to either the Alecensa arm or the crizotinib arm in a one to one ratio. The primary endpoint of the ALEX study was PFS as assessed by the investigator. The secondary endpoints included independent review committee (IRC)-assessed PFS, IRC-assessed time to CNS progression, objective response rate, overall survival, safety and other endpoints.

Summaries of the ALEX study results
Efficacy:

- At the primary data cut-off, Alecensa arm demonstrated statistically significant improvement superiority vs crizotinib arm, reducing risk of progression or death by 53% (HR=0.47, 95%CI: 0.34-0.65, stratified log-rank test, p<0.0001) by investigators’ assessment. Median PFS was not reached (95%CI: 17.7-not reached) in the Alecensa arm while it was 11.1 months (95%CI: 9.1-13.1) in the crizotinib arm.

- According to independent review committee, Alecensa arm demonstrated statistically significant improvement superiority vs crizotinib arm, reducing risk of progression or death by 50% (HR=0.50, 95%CI: 0.36-0.70). Median PFS was 25.7 months (95%CI: 19.9-not reached) in the Alecensa arm while it was 10.4 months (95%CI: 7.7-14.6) in the crizotinib arm.

- Alecensa arm demonstrated improvement vs crizotinib arm, reducing risk of CNS progression or death by 84% (HR=0.16, 95% CI: 0.10-0.28).

- Overall survival data are currently considered immature with only about a quarter of events being reported.

Safety:

- Grade 3-5 adverse events (AEs) were less frequent with Alecensa arm, 41%, vs 50% with crizotinib arm.

- No new safety findings were observed in either arm.

About Alecensa

Alecensa is a highly selective oral ALK inhibitor created 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. Thus, Alecensa is able to remain active in the central nervous system and has proven activity against brain metastases.

Alecensa is currently approved in the United States, Kuwait, Israel, Hong Kong, Canada, South Korea, Switzerland, India, the EU, Australia, Taiwan and Singapore for the treatment of adult patients with ALK-positive, metastatic (advanced) NSCLC who have progressed on or those intolerant to crizotinib. In Japan, “Alecensa capsule 150mg” 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 is 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)

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.

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.
Casey Astringer
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

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Upon Conclusion of the Fourth Annual Forum for Promoting Peace in Muslim Societies, Scholars and Intellectuals Visit the Louvre Abu Dhabi Museum15.12.2017 14:38Tiedote

A high-level delegation of dignitaries, scholars and intellectuals participating in the fourth annual Forum for Promoting Peace in Muslim Societies, visited the Louvre Abu Dhabi museum. The delegation was headed by H.E Mustafa Ceric, former Grand Mufti of Bosnia; alongside Sheikh Mohammad Mukhtar Ould Imbala, Head of Mauritania’s Fatwa & Grievances Supreme Council; H.E Amar Mirghani Hussein, Sudanese Minister of (religious) Guidance and Endowments; and H.E Salho Jay, Imam of the Juma Masjid in South Africa. The Forum was held in Abu Dhabi from 11-13 December 2017, with the participation of more than 700 scholars, intellectuals and religious dignitaries from around the world. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171215005255/en/ Group Photo of the Scholars and Intellectuals during their visit to the L

Kennedy Wilson Acquires 124-Unit Northbank Apartments in Dublin, Ireland for €45 Million15.12.2017 14:00Tiedote

Global real estate investment company Kennedy Wilson (NYSE: KW) announces that it has acquired Northbank Apartments, a wholly-owned 124-unit apartment community in Dublin’s North Docks, for €45 million from Jarmar Properties Limited (In Receivership) acting through David Carson of Deloitte as Statutory Receiver, the lender being the National Asset Management Agency (“NAMA”). Situated in Dublin’s North Docks, Northbank is located just 50 meters from Kennedy Wilson’s existing 84-unit Liffey Trust apartments. The two buildings benefit from great transport links as the LUAS Red line is immediately adjacent connecting to Dublin’s city centre and main train stations in five minutes. “The successful acquisition of Northbank in such close proximity to our Liffey Trust asset allows us to leverage our existing presence and implement our value-add asset management strategy, including a

AML BitCoin Enters Phase II of ICO15.12.2017 12:00Tiedote

NAC Foundation, LLC announces today that the initial coin offering for the AML BitCoin – the world’s only patent-pending compliant digital currency – has been extended for another month to accommodate a torrent of last minute, new coin purchasers and the demands of thousands of current owners of the coin, who have had difficulty navigating the process of establishing the specialized wallet required to hold the innovative digital currency. This second phase of the AML BitCoin initial coin offering will see an increase in the price of the coin, from US $1.00 to US $1.25. The company has already been contacted by prospective purchasers in the slightly higher priced Phase II, and anticipates a further price increase to US $1.50 within a week or two. HitBTC, one of the world’s largest and most active digital currency exchanges, was prepared to list the AML BitCoin for trading on

Joensuu City Challenge – International Competition for Innovative SMEs Opened15.12.2017 11:24Tiedote

City of Joensuu, Finland, has announced an international competition in which 200,000 euros will be used for innovative pilot projects in the city centre. Joensuu has defined four city platforms on which companies or other interested organizations are invited to present innovative proposals. The winning proposals will be implemented as pilot projects in Joensuu. The deadline for the proposals is 18th March 2018. The implementation phase of the proposals should be carried out by May 2019. Competition information is provided in English, and proposals can be made in English and Finnish. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171215005170/en/ Joensuu City Challenge - International Competition for Innovative SMEs Opened (Photo: Business Wire) The four challenges for which solutions are sought are v

Gilead Sciences Announces That John C. Martin, PhD Will Transition From Executive Chairman to Chairman of the Board of Directors15.12.2017 00:30Tiedote

Gilead Sciences, Inc. (Nasdaq:GILD) today announced that Executive Chairman John Martin, PhD will transition from his current role of Executive Chairman to Chairman of the Board of Directors effective March 9, 2018. Dr. Martin was named Executive Chairman on March 10, 2016, when he was succeeded as CEO by John Milligan, PhD. Dr. Martin served as CEO of Gilead from 1996 to 2016, having joined the company in 1990 as the Vice President of Research and Development. During his time as CEO, he built the company’s portfolio to 24 marketed products with annual revenues of more than $32 billion. “John's scientific and business leadership has been notable for the development of Gilead’s portfolio of HIV and viral hepatitis medicines and commitment to worldwide access for patients. We are all grateful that he will continue to help guide the company as Chairman of the Board,” said Dr. Milligan, Pr

UniPrint Infinity Now Available in Epic App Orchard14.12.2017 22:07Tiedote

UniPrint.net announced today that UniPrint Infinity software is now available in the Epic App Orchard Marketplace. Users can now take advantage of UniPrint Infinity’s secure release print suite which works with any printer, any device, and in any computing environment. UniPrint Infinity’s PDF-based Healthcare Printing Suite provides industry standard 256-bit data encryption and compression, high availability, archiving, and “follow-the-user” printing, resulting in increased security and compliance in addition to reduced print costs. Implementation of UniPrint Infinity is proven to reduce wait times and help desk calls. By improving workflows for doctors, nurses, and other healthcare providers, UniPrint Infinity allows healthcare staff to focus their attention on their most important task: providing better patient care. “Building upon our recent Imprivata SSO integrati

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme