Business Wire

AstraZeneca and Chi-Med’s Savolitinib Shows Encouraging Clinical Activity in 2nd-Line EGFR Mutation-positive Lung Cancer with MET-amplification

Jaa

AstraZeneca and its partner Chi-Med today presented preliminary safety and clinical activity of savolitinib when given in combination with either Tagrisso (osimertinib) or Iressa (gefitinib) in two Phase Ib trials conducted in patients with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) with MET-amplification who had progressed following 1st-line treatment with an EGFR inhibitor.1,2 In both trials, the addition of savolitinib (600mg, once daily), an investigational selective inhibitor of c-MET (mesenchymal epithelial transition factor) receptor tyrosine kinase, to osimertinib (80mg, once daily) or gefitinib (250mg, once daily) demonstrated preliminary anti-tumour activity. The data were shared in two oral presentations at the International Association for the Study of Lung Cancer 18th World Conference on Lung Cancer (WCLC) in Yokohama, Japan, 15-18 October 2017.

Dr. Myung-Ju Ahn, Department of Haematology & Oncology, Samsung Medical Centre, Seoul, South Korea, said: “Secondary resistance mechanisms often emerge during treatment with mutation-targeted medicines, leading to disease progression. The data presented at WCLC demonstrate the potential of utilising savolitinib in cMET-driven lung cancers to address resistance challenges.”

Susan Galbraith, Head of Oncology, AstraZeneca Research and Early Development, said: “We are committed to developing innovative medicines to overcome the key drivers of cancer mechanisms of resistance and are strategically focused on developing effective combinations. The latest results for savolitinib in combination with osimertinib and gefitinib support our approach in collaboration with Chi-Med.”

Preliminary results for savolitinib in combination with osimertinib 1

Early data on safety and anti-tumour activity for savolitinib (600mg, once daily) plus osimertinib (80mg, once daily) in the Phase Ib TATTON trial in patients with EGFR mutation-positive (EGFRm) advanced NSCLC with MET-amplification were presented. In 66 patients treated with savolitinib plus osimertinib, the most common all-causality adverse events (AEs) of any grade were nausea (44%), vomiting (35%), fatigue (30%), and decreased appetite (30%), and were consistent with the known safety profiles of both therapies.

Preliminary data showed partial response according to RECIST 1.1 criteria in 28% of patients previously treated with third-generation T790M-directed EGFR tyrosine kinase inhibitors (TKIs), including osimertinib (n=25). In patients who had progressed after prior treatment with a first- or second-generation EGFR inhibitor, 53% of T790M-negative patients (n=15) had a partial response, while 57% of T790M-positive patients (n=7) had a partial response.

Preliminary data for savolitinib in combination with gefitinib 2

Data from a Phase Ib trial assessing savolitinib (600mg, once daily) plus gefitinib (250mg, once daily) in patients in China with EGFRm advanced NSCLC with MET-amplification who progressed following EGFR-TKI therapy were also reported. The most common AEs independent of causality in 51 patients were vomiting (39%), increased ALT (37%), increased AST (35%), nausea (35%), and rash (35%), and were consistent with the known safety profiles of both therapies.

Preliminary results showed that 31% of patients achieved a partial response according to RECIST 1.1 criteria, of which 52% of T790M-negative patients (n=23) and 9% of T790M-positive patients (n=23) had a partial response.

Christian Hogg, Chief Executive Officer of Chi-Med, said: “MET-amplification impacts a meaningful proportion of patients with EGFRm NSCLC who experience disease progression following treatment with a tyrosine kinase inhibitor in the first- or second-line setting. Among patients with this difficult-to-treat resistance mechanism, there is a clear unmet medical need.”3-6

- ENDS -

NOTES TO EDITORS

About savolitinib

Savolitinib (AZD6094/HMPL-504) is a potential first-in-class selective inhibitor of c-MET (also known as mesenchymal epithelial transition factor) receptor tyrosine kinase, an enzyme which has been shown to function abnormally in many types of solid tumours. It was developed as a potent and highly selective oral inhibitor.

Savolitinib was discovered by Chi-Med and is being developed in collaboration with AstraZeneca. Savolitinib is currently being studied in multiple tumour types worldwide including kidney, lung, and gastric cancers, both as a monotherapy or in combination with other targeted and immunotherapy agents.

About Tagrisso

Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI designed to inhibit both EGFR-sensitising and EGFR-T790M resistance mutations, with clinical activity against central nervous system (CNS) metastases. Osimertinib 40mg and 80mg once-daily oral tablets have been approved in more than 50 countries, including the US, EU, Japan and China, for patients with EGFR T790M mutation-positive advanced NSCLC. Osimertinib is also being investigated in the adjuvant setting and in combination with other treatments.

About NSCLC

Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-quarter of all cancer deaths, more than breast, prostate and colorectal cancers combined. Approximately 10-15% of patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC. These patients are particularly sensitive to treatment with currently available EGFR-TKIs, which block the cell signalling pathways that drive the growth of tumour cells. However, tumours almost always develop resistance to EGFR-TKI treatment, leading to disease progression. Approximately half of patients develop resistance to approved EGFR-TKIs such as gefitinib and erlotinib due to the resistance mutation, EGFR T790M. Osimertinib also targets this secondary mutation that leads to disease progression. There is also a need for medicines with improved CNS efficacy, since approximately 25% of patients with EGFR-mutated NSCLC have brain metastases at diagnosis, increasing to approximately 40% within two years of diagnosis.

About AstraZeneca in Lung Cancer

AstraZeneca is committed to developing medicines to help every patient with lung cancer. We have two approved medicines and a growing pipeline that targets genetic changes in tumour cells and boosts the power of the immune response against cancer. Our unrelenting pursuit of science aims to deliver more breakthrough therapies with the goal of extending and improving the lives of patients across all stages of disease and lines of therapy.

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s five Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

For more information, please visit www.astrazeneca.com and follow us on Twitter @AstraZeneca.

About Chi-Med

Hutchison China MediTech, known as Chi-Med, is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products. Its Innovation Platform, Hutchison MediPharma, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China. Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings.

For more information, please visit www.chi-med.com.

Intended audiences

This press release is issued from AstraZeneca Corporate Headquarters in Cambridge, UK and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where AstraZeneca conducts business.

References

1 Ahn M-J, et al. TATTON Phase Ib Expansion Cohort: Osimertinib Plus Savolitinib for Patients with EGFR-mutant MET-amplified NSCLC After Progression on Prior EGFR-TKI. Abstract #8985. To be presented at the World Lung Cancer Congress (WCLC) 2017, Yokohama, Japan, 15-18 October 2017.

2 Yang J-J, et al. A Phase Ib Trial of Savolitinib Plus Gefitinib for Patients with EGFR-mutant MET-amplified Advanced NSCLC. Abstract #8995. To be presented at the World Lung Cancer Congress (WCLC) 2017, Yokohama, Japan, 15-18 October 2017.

3 Stewart EL, et al. Known and Putative Mechanisms of Resistance to EGFR Targeted Therapies in NSCLC Patients with EGFR Mutations—a Review. Transl Lung Cancer Res. 2015:4(1):67–81.

4 Engelman et al. MET Amplification Leads to Gefitinib Resistance in Lung Cancer by Activating ERBB3 Signaling. Science 2007;316:1039-1043.

5 Bean et al. MET amplification occurs with or without T790M mutations in EGFR mutant lung tumors with acquired resistance to gefitinib or erlotinib. Proc Natl Acad Sci USA 2007;104:20932–20937.

6 Sequist et al. Genotypic and Histological Evolution of Lung Cancers Acquiring Resistance to EGFR Inhibitors. Science Transitional Medicine 2011; 3(75):75ra26.

Contact information

AstraZeneca
Karen Birmingham
+ 44 781 852 4012
or
Ashley DiLeo
+1 301 398 1478
or
Hugues Joublin
+1 301 398 3041

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

New England Journal of Medicine Publishes Results of Phase III FLAURA Trial in the 1st-Line Treatment of EGFR-mutated Non-small Cell Lung Cancer18.11.2017 21:20Tiedote

AstraZeneca today announced that the New England Journal of Medicine has published the positive results from the Phase III FLAURA trial which provide data for Tagrisso’s (osimertinib) use in the 1st-line treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).1 The trial showed a statistically significant, clinically meaningful progression-free survival (PFS) advantage for osimertinib, a third-generation, irreversible EGFR tyrosine kinase inhibitor (TKI), compared with current 1st-line EGFR-TKIs, erlotinib or gefitinib.1 This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171118005044/en/ Dr. Suresh S. Ramalingam, Principal Investigator of the FLAURA trial, from the Winship Cancer Institute

Much-Anticipated CHTF 2017 Top 10 Products Are Unveiled18.11.2017 12:11Tiedote

The 19th China Hi-Tech Fair (CHTF 2017), with the theme of “Innovation-Driven Development and Supply Quality Upgrade”, is taking place from November 16 to 21 at Shenzhen Convention and Exhibition Center. On the afternoon of November 10, the CHTF 2017 Top 10 Products were unveiled at the awards ceremony by Mr. Gao Zimin, Vice Mayor of Shenzhen City. A total of 322 entries competed for the honor Top 10 Products, and the voting lasted nearly 3 months. 60 candidate products in the fields of new energy, 3D print, flexible display, life sciences, unmanned vehicles and AI were shortlisted by the organizer, experts and media representatives and went for open voting online. The final Top 10 Products all represent the most advanced technologies in their respective sectors: the water-making device that can make water out of air, the smart sportswear that can monitor heartbeat and other

Madison Realty Capital Provides $64.0 Million Construction Financing for 200 Kent Avenue Development in Williamsburg, Brooklyn17.11.2017 19:20Tiedote

Madison Realty Capital (MRC) announced the closing of a $64.0 million construction loan for 200 Kent Avenue, a 117,326 square foot mixed-use development located in Williamsburg, Brooklyn. The retail portion of the property, which will include over 600 feet of frontage, will be anchored by a popular national grocery chain. Overall, the project will offer 50,101 square feet of retail space, 22,055 square feet of office and restaurant space, and 45,170 square feet of parking. “We continue to establish MRC as the one-stop shop for financing transitional real estate, including ground-up development deals like 200 Kent Avenue,” said Josh Zegen, Co-Founder and Managing Principal of MRC. “In this case, we’re working with a repeat MRC borrower who understands our ability to execute efficiently, given our firm’s up-to-the minute knowledge of local market conditions and non-bureaucratic approach to

Ncardia Announces Completion of €10.5M Investment Round17.11.2017 15:31Tiedote

Ncardia, an emerging drug discovery and development stem cell technology company whose mission is to deliver cardiac and neural solutions based on its best-in-class human induced pluripotent stem cell (iPSC)-derived technology, today announced the completion of a €10.5 million series B financing round. The round was led by Épimède, a Belgium venture capital firm. Ncardia is a privately-held company with operations in Europe and the US, that produces and commercializes high-quality, fully-functional human iPSC-derived cardiovascular and neuronal cell types. Using its cell products, Ncardia develops and commercializes assay services for drug safety and efficacy testing. Additionally the company has built up a strong portfolio of patents covering the use of stem cell models for these applications. Stefan Braam, CEO of Ncardia, commented: “At Ncardia, important progress h

Double Win for Vocalink at the 2017 Payments Awards17.11.2017 12:35Tiedote

Vocalink, a Mastercard company, was last night awarded with two prestigious awards - The Overall Winner and the Payments Infrastructure of the Year Award, for its leading technology and expertise, and in recognition for a milestone year that saw Vocalink’s solutions transform the way people and businesses move money across the globe. 2017 saw Vocalink deliver ground-breaking immediate payments solutions both in the US and Thailand as well as enabling access to the UK payments industry through their payments gateway solution PayPort. The business also saw the launch of the new image based cheque clearing system, creating a robust and more efficient system in the UK. RTP ® in the US: This week, Vocalink announced the launch of RTP® (Real-Time Payments) in the US on behalf of The Clearing House; one of the most comprehensive real-tim

Envion AG: Start-up from the Heart of Berlin Has Pioneered Decentralized Mobile Mining by Combining Blockchain with Regenerative Energy17.11.2017 12:00Tiedote

Envion AG has created a technology for the first truly mobile data-center that uses low-priced local energy to mine a broad spectrum of cryptocurrencies (Bitcoin, Ethereum, etc.). By harvesting locally available clean energy right at the source, envion can operate at lower costs than competitors and at the same time reduces the CO2 footprint of the blockchain industry. Envion aims at decentralizing the highly-concentrated mining market (China holds 80% in Bitcoin mining) and at bringing control of the market back to the users. That’s why envion gives 100% of its mining profits back to its community. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171117005011/en/ Envion - World's Most Profitable Standard of Self-Expanding Crypto Infrastructure (Photo: Business Wire) Current challenges in the energy

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