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
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
H.I.G. Realty Invests in Production Studios & Content Hub in Madrid15.1.2021 11:00:00 EET | Press release
H.I.G. Capital, LLC ("H.I.G."), a leading global alternative investment firm with $43 billion of equity capital under management, announced today that one of its affiliates has invested in Madrid Content City, an approximately 140,000 square meter hub with state of the art audio-visual facilities, including production studios, production & post-production technical facilities, and a university focused on media studies. H.I.G. continues to add to its sizeable portfolio of real estate assets across Europe, consisting of both equity as well as debt investments, with a particular focus on its target market of value-added small and midcap opportunities. Riccardo Dallolio, Managing Director and Head of H.I.G. Europe Realty Partners, commented: “Madrid Content City will benefit from strong secular tailwinds underpinned by the boom in content production. The state-of-the-art studios and related facilities, the exceptional multinational tenant line-up with long term leases, and its critical mas
Eurofins, the global leader in analytical testing, expands worldwide face mask testing & certification capabilities15.1.2021 09:30:00 EET | Press release
Since the start of the pandemic Eurofins (Paris:ERF) has tested thousands of models of surgical and hygienic masks and provided best-in-class speed and certification for PPEs globally, enabling these critical products to get market as fast as possible. Eurofins has developed global leading testing capabilities and certification services in the North America, Europe and Asia ensuring that PPE manufacturers are able to provide the indispensable support needed in the fight against the coronavirus. As of today, Eurofins is one of the few GLP certified and ISO/IEC 17025 accredited laboratory networks to fully cover all testing requirements for surgical/medical and hygienic masks by the FDA, EU regulations and many international and country-specific directives and guidelines such as CEN, CE Marking, ISO, ASTM or OECD. Our robust portfolio for masks includes globally accepted, safety and performance testing, virucidal, bacterial filtration, particle filtration, differential pressure, biocompa
TOXINS 2021: New analyses of pivotal Phase III trial data highlight long duration of response for Dysport® (abobotulinumtoxinA) in five therapeutic indications15.1.2021 09:00:00 EET | Press release
Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) announced results from new analyses of pivotal Phase III clinical trial data to assess treatment intervals over repeat cycles of Dysport® (abobotulinumtoxinA [aboBoNT-A]) in five patient populations. AbobotulinumtoxinA: Evidence for Long Duration of Response from 5 Patient Populations is being shared during the TOXINS 2021 conference, which is taking place virtually between 16-17 January 2020 and is organized by the International Neurotoxin Association.1-28 Ipsen is sharing 26 abstracts during the congress, with data including updates from the recently published surveys into the experience of patients and caregivers, data from the Phase IV ULIS-III trial, and ten abstracts focused on basic science research into neurotoxins.1-27 Spasticity is one of the most common and disabling conditions associated with many neurological conditions in adults and is characterized by velocity-dependent muscle hypertonia. Spasticity can lead to disabilit
Velodyne Lidar Commends NHTSA Plan to Update NCAP14.1.2021 23:58:00 EET | Press release
Velodyne Lidar, Inc. (Nasdaq: VLDR, VLDRW) today commended the U.S. Department of Transportation’s National Highway Traffic Safety Administration (NHTSA) plan to update to its New Car Assessment Program (NCAP). The NHTSA proposal would add four advanced driver assistance system (ADAS) capabilities to the NCAP, keeping pace with evolving safety technologies and providing much-needed information to consumers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210114005992/en/ Images show vehicle with lidar-based PAEB stopping before adult target @ 50% overlap (above) and vehicle with camera and radar-based PAEB crashing into adult target (below). (Photo: Velodyne Lidar, Inc.) NCAP is the U.S. Government’s premier consumer information program for evaluating vehicle safety performance. The NHTSA proposal to add ADAS technologies to the NCAP includes pedestrian automatic emergency braking, lane keeping support, blind spot warning and
Veristat Supported Marketing Applications for 10% of All FDA Novel Drug Approvals in 202014.1.2021 21:15:00 EET | Press release
Veristat, a scientific-minded global clinical research organization (CRO), announced today that they supported the marketing applications for 10% of the 2020 US Food and Drug Administration (FDA) novel drug approvals. The FDA approved 53 novel drugs, defined by the FDA as New Molecular Entities (NMEs)i, and Veristat regulatory, statistical, and medical writing experts were integral in preparing five of these NME New Drug Applications. Veristat also prepared NDA/BLAs for three non-NME FDA approvals and one Marketing Authorization Application (MAA) that received approval in Europe. "Despite the global challenges in 2020, Veristat continued to advance its mission of helping clients achieve regulatory approval of novel medical therapies," stated Patrick Flanagan, Chief Executive Officer at Veristat. "Now, more than ever, Veristat is focused on providing expert guidance to facilitate the rapid approval for therapies that improve the lives of patients and their families around the world." Ve
Tigo Energy Raises $20 Million in Funding14.1.2021 19:33:00 EET | Press release
Tigo Energy, Inc., the worldwide leader in Flex-MLPE (Module Level Power Electronics) today announced a $20 million round of investment, led by Energy Growth Momentum. “2020 has been a breakout year for Tigo and 2021 has the potential for even greater success,” stated Zvi Alon, Chairman and CEO of Tigo. “We are excited to have the EG Momentum team’s support and their working capital will enable us to better serve our current customer base and invest in the future expansion with new customers, new partners and new projects.” The investment will be used to improve upon existing products and develop next generation solutions that maximize returns for PV customers. A portion of the new funds will be used to efficiently and effectively scale. Tigo’s growth has accelerated significantly recently as the company’s products have reached more customer segments and countries throughout the world. With over 40,000 installations in over 100 countries on all 7 continents, Tigo systems generate more
Samsung’s Newest 108Mp Mobile Image Sensor with Advanced Features Captures More Details and Produces Sharper Results14.1.2021 19:00:00 EET | Press release
Samsung Electronics Co., Ltd., a world leader in advanced semiconductor technology, today introduced its latest 108-megapixel (Mp) mobile image sensor, Samsung ISOCELL HM3. With a wide spectrum of advanced sensor technologies, the HM3 can capture sharper and more vivid images in ultra-high resolution with faster auto-focus and extended dynamic range. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210114005430/en/ ISOCELL HM3 - 108 megapixel image sensor (Graphic: Business Wire) “While a pixel is just a single dot of color, when in millions, these dots can be transformed into stunning snapshots of life. With more pixels, images are sharper, with fuller details that can maintain their integrity even when enlarged. Samsung has been at the forefront of bringing the most pixels to mobile image sensors as well as various supporting technologies that take sensor performances to the next level,” said Duckhyun Chang, executive vice p
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