Janssen Submits European Marketing Authorisation Application for Amivantamab for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
FOR EU TRADE AND MEDICAL MEDIA ONLY NOT FOR DISTRIBUTION IN BENELUX AND THE UK
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of amivantamab for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed after failure of platinum-based chemotherapy. The application marks the first-ever regulatory submission in the EU for a treatment for patients with NSCLC that specifically targets EGFR exon 20 insertion mutations.1
Amivantamab is an investigational, fully-human EGFR and mesenchymal epithelial transition factor (MET) bispecific antibody with immune cell-directing activity that targets tumours with activating and resistance EGFR and MET mutations and amplifications.2,3,4,5
“The EMA submission represents an important milestone in our commitment to develop innovative, targeted therapies like amivantamab for patients facing a lung cancer diagnosis,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. “This is an important step forward in our drive towards improving outcomes for patients diagnosed with NSCLC who have EGFR exon 20 insertion mutations where there are no EMA-approved targeted treatments today.”
The EMA submission for amivantamab is based on monotherapy data from the Phase 1 CHRYSALIS study, a multi-centre, open-label, multi-cohort study evaluating the safety and efficacy of amivantamab as a monotherapy and in combination with lazertinib,* a novel third-generation EGFR tyrosine kinase inhibitor (TKI),6 in adult patients with advanced NSCLC.7 In the study, investigators assessed efficacy using overall response rate per Response Evaluation Criteria in Solid Tumours Version 1.1** (RECIST v1.1), clinical benefit rate, and duration of response and progression-free survival, as well as the safety profile of amivantamab.7,8 This data was also the basis of the submission of the Biologics License Application for amivantamab to the U.S. Food and Drug Administration (FDA) in December 2020. Early data about amivantamab as a monotherapy treatment in patients with NSCLC with EGFR exon 20 insertion mutations were presented at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program (Abstract #9512).8
“Lung cancer is the biggest cause of cancer death in Europe and has one of the lowest five-year survival rates for patients with cancer.9 Given this significant unmet need, we are committed to improving outcomes for patients diagnosed with this complex disease,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. “With today’s submission for amivantamab, we are one step closer to our goal of advancing novel therapeutics that will transform the trajectory of some of the most challenging diseases of our time, including lung cancer.”
“Lung cancer is responsible for 20% of cancer deaths in Europe: more than breast and prostate cancer combined.9 Despite advances in treatment, there is still a high unmet need amongst patients with EGFR-mutated NSCLC, particularly in the exon 20 insertion mutation population due to poor response to treatments that work for other mutations,10” said Joaquín Casariego, M.D., Therapeutic Area Lead Oncology for Europe, Middle East & Africa, Janssen-Cilag, S.A. “We are encouraged by the promising results of amivantamab which continue to demonstrate potential for providing a new treatment option for patients with advanced NSCLC with EGFR exon 20 insertion mutations.8 This submission is an important milestone, and we look forward to working closely with the EMA as the application process progresses.”
EGFR mutations, which drive tumours by causing uncontrolled cancer cell growth and division,11 are some of the most common mutations in NSCLC.12 EGFR exon 20 insertion mutations are the third most prevalent primary EGFR mutation.13 However, EGFR exon 20 insertions are also often undetected.13 Next Generation Sequencing (NGS) is effective at detecting EGFR exon 20 insertions and broader use of NGS can help to detect these mutations.13 Cancer driven by EGFR exon 20 insertion mutations is generally insensitive to approved EGFR TKI treatments and has a worse prognosis compared with cancer driven by more common EGFR mutations, including exon 19 deletions/L858R substitutions.10 Patients with EGFR exon 20 insertion mutations have a median survival of 16 months,14 which is much lower than patients with EGFR exon 19 deletions or L858R substitutions, who have a median survival of 32-39 months.15
*In 2018, Janssen Biotech, Inc. entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib.
**RECIST (version 1.1) refers to Response Evaluation Criteria in Solid Tumours, which is a standard way to measure how well solid tumours respond to treatment and is based on whether tumours shrink, stay the same, or get bigger.
Amivantamab is an investigational, fully-human EGFR-MET bispecific antibody with immune cell-directing activity that targets tumours with activating and resistance EGFR mutations and MET mutations and amplifications.2,3,4,5 Amivantamab is pending regulatory review as a potential treatment for NSCLC patients with EGFR exon 20 insertion mutations after failure of platinum-based chemotherapy. The production and development of the antibody followed Janssen Biotech, Inc.’s licensing agreement with Genmab for use of its DuoBody® technology platform.16
About Non-Small Cell Lung Cancer (NSCLC)
In Europe, it is estimated that over 470,000 patients were diagnosed with lung cancer in 2018, with around 85 percent diagnosed with NSCLC.17,18 Lung cancer is Europe’s biggest cancer killer, with more deaths than breast cancer and prostate cancer combined.19 The five-year survival rate for patients with metastatic NSCLC is currently 24 percent.19
The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma and large cell carcinoma.20 Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase supporting cells growth and division.11 EGFR mutations are present in 10 to 15 percent of Caucasian patients with NSCLC and occur in 40 to 50 percent of Asian patients who have NSCLC adenocarcinoma.12 Estimated median overall survival for patients with NSCLC and EGFR exon 20 insertion mutations is shorter than in patients with more common EGFR mutations.14
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology and Pulmonary Hypertension.
Learn more at www.janssen.com/emea/. Follow us at https://twitter.com/JanssenEMEA for our latest news. Janssen Research & Development, LLC; Janssen-Cilag, S.A. and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
DuoBody® is a registered trademark of Genmab A/S.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of amivantamab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC or any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
1 Remon, J et al. EGFR exon 20 insertions in advanced non-small cell lung cancer: A new history begins. Cancer Treatment Reviews. 90 (2020).
2 Grugan et al. Fc-mediated activity of EGFR x c-Met bispecific antibody JNJ-61186372 enhanced killing of lung cancer cells MAbs. 2017;9(1):114-126.
3 Moores et al. A Novel Bispecific Antibody Targeting EGFR and cMet Is Effective against EGFR Inhibitor-Resistant Lung Tumors. Cancer Res. 2016;76(13)(suppl 27216193):3942-3953.
4 Yun et al. Antitumor Activity of Amivantamab (JNJ-61186372), an EGFR–MET Bispecific Antibody, in Diverse Models of EGFR Exon 20 Insertion–Driven NSCLC. Cancer Discov. 2020;10(8):1194-1209.
5 Vijayaraghavan et al. Amivantamab (JNJ-61186372), an Fc Enhanced EGFR/cMet Bispecific Antibody, Induces Receptor Downmodulation and Antitumor Activity by Monocyte/Macrophage Trogocytosis. Mol Cancer Ther. 2020;19(10):2044-2056.
6 Ahn, J. et al. Lazertinib in patients with EGFR mutation-positive advanced non-small-cell lung cancer: results from the dose escalation and dose expansion parts of a first-in-human, open-label, multicentre, phase 1–2 study. Lancet Oncology. 2019. 20 (12): 1681-1690.
7 ClinicalTrials.gov. Study of JNJ-61186372, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer. Available at: https://clinicaltrials.gov/ct2/show/NCT02609776. Accessed December 2020.
8 Park, K. et al. Amivantamab, an Anti-EGFR-MET Bispecific Antibody, in Patients with EGFR Exon 20 Insertion-Mutated NSCLC. https://meetinglibrary.asco.org/record/184802/abstract. Accessed December 2020.
9 Lung Cancer Europe. LUCE Report on Lung Cancer: Challenges in lung cancer in Europe. 2016. Available at: https://www.lungcancereurope.eu/wp-content/uploads/2017/10/LuCE-Report-final.pdf. Accessed December 2020.
10 Vyse, S., Huang, P.H. Targeting EGFR exon 20 insertion mutations in non-small cell lung cancer. Sig Transduct Target Ther 4, 5 (2019).
11 Wee,P, Wang, Z. Epidermal Growth Factor Receptor Cell Proliferation Signaling Pathways. Cancers (Basel). 2017 May; 9(5): 52.
12 Zhang, Y. et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget. 2016 Nov 29; 7(48): 78985–78993.
13 Riess JW, Gandar DR, Frampton GM, et al.Diverse EGFR Exon 20 insertions and co-occurring molecular alterations identified by comprehensive genomic profiling of NSCLC. J Thorac Oncolo. 2018;13(10):1560-1568. 10.1016/j.jtho.2018.06.019.
14 Oxnard, JR et. al. Natural history and molecular characteristics of lung cancers harboring EGFR exon 20 insertions. J Thorac Oncol. 2013 Feb;8(2):179-84. doi: 10.1097/JTO.0b013e3182779d18.
15 Ramalingam SS, Vansteenkiste J, Planchard D, Cho BC, Gray JE, Ohe Y, et al. Overall Survival with Osimertinib in Untreated, EGFR-Mutated Advanced NSCLC. N Engl J Med. 2020 Jan 2;382(1):41-50.
16 Genmab.com. Genmab Enters Broad Collaboration with Janssen Biotech, Inc. for DuoBody Platform. Available at: https://ir.genmab.com/news-releases/news-release-details/genmab-enters-broad-collaboration-janssen-biotech-inc-duobody. Accessed December 2020.
17 American Cancer Society. What is Lung Cancer? https://www.cancer.org/content/cancer/en/cancer/lung-cancer/about/what-is.html. Accessed December 2020.
18 Globocan 2018. Europe factsheet. Available at: https://gco.iarc.fr/today/data/factsheets/populations/908-europe-fact-sheets.pdf. Accessed December 2020.
19 Cancer.net. Lung Cancer - Non-Small Cell: Statistics. https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics. Accessed December 2020.
20 Herbst, R. et al. The biology and management of non-small cell lung cancer. Nature 2018 Jan 24;553(7689):446-454. doi: 10.1038/nature25183.
Phone: +31 621 38 5718
Phone: +44 7917 849 211
Phone: +1 732-524-2955
Phone: +1 732-524-3922
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
Leading Dutch crypto exchange LiteBit partners with RIDDLE&CODE to pave the way towards regulatory compliance and launch the next generation of crypto services13.4.2021 10:15:00 CEST | Press release
RIDDLE&CODE FinTech Solutions, an innovative European company that empowers financial institutions to handle all aspects of digital asset management, announced today that LiteBit, the leading Dutch cryptocurrency exchange, has chosen its Token Management Platform (TMP) to scale infrastructure, respond to regulatory requirements and provide advanced capabilities to its growing customer base. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210413005034/en/ Over the last few years, the European Union has significantly tightened its regulations on crypto service providers, including the recently updated 5th Anti-Money Laundering Directive (AMLD5). The newly implemented AMLD5 guidelines oblige service providers such as crypto exchanges and custodians to adhere to the same regulatory provisions as traditional financial institutions. “The Dutch implementation of the regulations currently goes beyond EU guidelines and calls for exten
NATO Relies on Thales for a Real-Time View of the Operational Situation in Joint theaters13.4.2021 10:00:00 CEST | Press release
On 17 March 2021, NATO awarded to Thales the new increment to provide an operational situational awareness system that will give NATO commanders a shared picture of an area of interest or mission to enhance overall awareness of joint forces operations and support mission planning, coordination and command. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210413005102/en/ Representation of a NATO command and control center with NCOP vision on the screen © Thales Joint operations today involve land, air and naval units with many different types of command systems, which generate huge amounts of georeferenced operational information. NCOP will capture, aggregate and correlate all this information to generate a single, comprehensive picture of the theatre of operations, providing a Common Operational Picture (COP) that will ensure that each entity has a shared view of the location, actions and intentions of the forces in the field
Alkira Teams Up with Microsoft to Transform the Cloud Networking Journey to Azure13.4.2021 10:00:00 CEST | Press release
Network Cloud pioneer Alkira® today announced a close collaboration with the Microsoft for Startups program, a select group of emerging businesses hand-picked by Microsoft for the benefits they offer to Microsoft Azure customers in their journey to the cloud. The select start-ups receive growth partnership and ecosystem support from Microsoft including access to technical, sales and marketing opportunities and leadership. Alkira also announced that the Alkira Cloud Services Exchange (CSX) – the core of the company’s Network Cloud platform – is now available on the Azure Marketplace. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210413005521/en/ Alkira CEO and Founder Amir Khan and CTO and Founder Atif Khan are collaborating with Microsoft to accelerate Multi-cloud Networking for Azure customers. (Photo: Business Wire) The Alkira Network Cloud platform which reduces the time, cost and complexity of connectivity cloud environ
European IT and Business Services Market Remains Robust, ISG Index™ Finds13.4.2021 10:00:00 CEST | Press release
The European market for IT and business services remains robust, with record demand for cloud-based services in the first quarter and continued strength in managed services, according to the latest state-of-the-industry report from Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm. The EMEA ISG Index™, which measures commercial outsourcing contracts with annual contract value (ACV) of US $5 million or more, shows ACV for the combined market, which includes both as-a-service and managed services, reached US $6.0 billion, up 20 percent year on year, but off 5 percent from a record fourth quarter. Cloud-based as-a-service ACV reached a quarterly record of US $2.5 billion, up 16 percent versus the prior year. Within this segment, infrastructure-as-a-service (IaaS) climbed 19 percent, to a record US $1.8 billion, while software-as-a-service (SaaS) rose 9 percent, to a record US $658 million. Managed services, meanwhile, produced its secon
Lexon Breaks Company Record with 6 Wins at the Red Dot Design Award 202113.4.2021 09:30:00 CEST | Press release
Lexon today announced that it has received 6 Red Dot Awards for its outstanding product design quality in multiple categories, setting a new company record for the number of awards won in a single competition. Sister company MyKronoz also takes home a Red Dot Award for its MyScale, a smart and design body scale with a large and intuitive color display. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210413005520/en/ Lexon’s award-winning products, from left to right: C-Pen, Mino+, Mina M, Mino T, Powersound and Oblio (Photo: Business Wire) This announcement comes only a few weeks after Lexon’s best-selling Oblio was honored with two prestigious international prizes - a TIME Best Invention Award and a CES Innovation Award - confirming the French brand’s continued leadership in innovative product design, with a total of more than 200 awards received since its creation in 1991. “2021 marks the 30th anniversary of Lexon, so this
AttackIQ Appoints New General Manager and Vice President of EMEA and APJ Regions13.4.2021 09:00:00 CEST | Press release
AttackIQ®, the leading independent vendor of Breach and Attack Simulation (BAS) systems, today announced that Ross Brewer has been promoted to General Manager and Vice President of Europe, Middle East and Africa (EMEA) and Asia Pacific Japan (APJ) regions. In his new role, Brewer will be responsible for developing the strategy to expand AttackIQ’s presence in the regions, including delivering IT security and risk management leaders with solutions to identify gaps in their security posture more effectively and prioritize security initiatives more efficiently. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210413005210/en/ Ross Brewer, General Manager and Vice President of Europe, Middle East and Africa (EMEA) and Asia Pacific Japan (APJ) regions. (Photo: Business Wire) Brewer brings more than 35 years of sales and management experience with technology organizations across the globe. He previously served as strategic advisor f
ADVA showcases 400ZR DCI solution with Acacia and Inphi13.4.2021 09:00:00 CEST | Press release
ADVA (FSE: ADV) today announced that it has successfully demonstrated interoperability between its next-generation FSP 3000 DCI open line system (OLS) and QSFP-DD 400ZR modules from Acacia Communications and Inphi Corporation. Conducted over a 120km amplified link, the tests show a clear path to commercial deployments of a complete solution with all the benefits of open, programmable networking. The trial featured 400Gbit/s WDM transport using low-power 400ZR pluggable QSFP-DD transceivers from Acacia and Inphi with ADVA’s FSP 3000 DCI OLS. It was carried out under real-world conditions with 400Gbit/s channels placed next to the test channels as well as a fully loaded spectrum. To validate three-way line-side interoperability, 400ZR was transmitted from Acacia to Inphi and vice versa. Test results showed that this multi-vendor ecosystem exceeds all OIF 400ZR Implementation Agreement performance metrics. Large-scale DCI network operators now have an easy and cost-effective route to a dy
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