Janssen to Highlight Commitment to Lung Cancer Science and Innovation with Eight Data Presentations at the International Association for the Study of Lung Cancer’s 2020 World Conference on Lung Cancer

RARITAN, N.J., Jan. 12, 2021 /PRNewswire/ — The Janssen Pharmaceutical Firms of Johnson & Johnson introduced at the moment that eight company-sponsored displays, together with two oral displays, will probably be featured on the Worldwide Affiliation for the Examine of Lung Most cancers’s (IASLC) 2020 World Convention on Lung Most cancers (WCLC) Singapore happening just about January 28-31, 2021. The displays embrace up to date knowledge from the Part 1 CHRYSALIS examine (NCT02609776) evaluating amivantamab in sufferers with NSCLC and EGFR exon 20 insertion mutations and two research that characterize the excessive unmet want and lack of ordinary of care in sufferers with exon 20 insertion mutations and the underdiagnosis of those sufferers in real-world settings.

Amivantamab is an investigational, absolutely human bispecific antibody that targets tumors by directing immune cell exercise in opposition to tumors with activating and resistance EGFR mutations and mesenchymal epithelial transition issue (MET) mutations and amplifications.^1,2,3,4  Janssen has filed regulatory submissions within the U.S. and Europe searching for approval of amivantamab for the remedy of sufferers with NSCLC and EGFR exon 20 insertion mutations whose illness has progressed on or after platinum-based chemotherapy.⁵ These functions mark the first-ever regulatory submissions of a remedy for sufferers with NSCLC and EGFR exon 20 insertion mutations.⁶ 

“We see an necessary alternative to enhance the analysis and remedy of sufferers with EGFR-mutated non-small cell lung most cancers, particularly for people with exon 20 insertion mutations. To that finish, we sit up for presenting knowledge highlighting the potential of amivantamab on this affected person inhabitants, and the significance of genetic testing to establish mutations which will impression remedy outcomes,” stated Kiran Patel, M.D., Vice President, Medical Improvement, Stable Tumors, Janssen Analysis & Improvement, LLC. “We’re centered and dedicated to reworking the trajectory of lung most cancers via improved diagnostics, novel therapeutics and interception methods.”

Lung most cancers is likely one of the most typical cancers and is the main explanation for most cancers deaths worldwide, with NSCLC making up 80 to 85 % of all lung cancers.^7,8 Sufferers with EGFR exon 20 insertion mutations have a median survival of lower than 17 months⁹, which is far shorter than sufferers with EGFR exon 19 deletions or L858R mutations, who’ve a median survival of 32-39 months on present therapies.¹⁰

Amivantamab Part 1 CHRYSALIS Examine Exhibits Promise for Sufferers with NSCLC and EGFR Exon 20 Insertion Mutations
New knowledge from the Part 1 CHRYSALIS examine evaluating the security and efficacy of amivantamab in sufferers with metastatic NSCLC and EGFR exon 20 insertion mutations whose illness has progressed on or after platinum-based chemotherapy will probably be introduced as an oral presentation (Summary #3031). Early outcomes from the CHRYSALIS examine have been presented on the American Society of Medical Oncology (ASCO) 2020 Digital Scientific Program (Abstract #9512).¹¹ 

Mini-Oral Presentation Underscores Unmet Want of Sufferers with EGFR Exon 20 Insertion Mutations  
A mini-oral presentation primarily based on real-world knowledge will present new insights into the variations in prognoses for sufferers with NSCLC and EGFR exon 20 insertion mutations in comparison with these with different EGFR mutations (Summary #3390).

Actual-World Datasets Highlight Underdiagnosis for Sufferers with Lung Most cancers with Genetic Alterations
Correct identification of driver mutations is a vital a part of lung most cancers diagnostic and staging processes.¹² A brand new evaluation of real-world genomic knowledge that will probably be introduced on the assembly (Summary #3399) estimates that genetic exams utilizing polymerase chain response (PCR) could miss as much as 50 % of tumors with EGFR exon 20 insertion mutations, suggesting vital underdiagnosis exists.   

Additional particulars about these knowledge and the science that Janssen is advancing for sufferers with lung most cancers will probably be made out there all through the IASLC 2020 WCLC by way of the Janssen Oncology Virtual Newsroom.

Firm-sponsored abstracts to be introduced on the assembly embrace:

About Amivantamab 
Amivantamab is an investigational, absolutely human EGFR-MET bispecific antibody with immune cell-directing exercise that targets tumors with activating and resistance EGFR mutations and MET mutations and amplifications.^1,2,3,4  Companion diagnostics utilizing Subsequent Era Sequencing, that are essential to establish sufferers with EGFR exon 20 insertion mutations, have been an integral a part of the event program for amivantamab. The bispecific antibody is being studied as a monotherapy in sufferers with EGFR exon 20 insertion mutations. Amivantamab can also be being studied together with lazertinib, a third-generation tyrosine kinase inhibitor (TKI)¹³, in grownup sufferers with superior NSCLC.¹⁴ The manufacturing and improvement of the antibody adopted Janssen Biotech, Inc.’s licensing settlement with Genmab to be used of its DuoBody^® know-how platform. 

About Lazertinib
Lazertinib is an oral, third-generation, brain-penetrant EGFR TKI that targets each the T790M mutation and activating EGFR mutations whereas sparing wild type-EGFR.¹⁵ Interim security and efficacy outcomes from the lazertinib Part 1-2 examine have been revealed in The Lancet Oncology in 2019. In 2018, Janssen Biotech, Inc. entered right into a license and collaboration settlement with Yuhan Company for the event of lazertinib.

About Non-Small Cell Lung Most cancers (NSCLC)
Worldwide, lung most cancers is likely one of the most typical cancers, and NSCLC makes up 80 to 85 % of all lung cancers.^7,8 The principle subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma and enormous cell carcinoma.⁸ Among the many most typical driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase supporting cell progress and division.¹⁶ EGFR mutations are current in 10 to fifteen % of sufferers with NSCLC and happen in 40 to 50 % of Asian sufferers who’ve NSCLC.¹⁷ The five-year survival charge for all sufferers with metastatic NSCLC and EGFR mutations handled with EGFR TKIs is lower than 20 %.^18,19 Estimated median general survival for sufferers with NSCLC and EGFR exon 20 insertion mutations is shorter than in sufferers with frequent EGFR mutations.¹⁶

Concerning the Janssen Pharmaceutical Firms of Johnson & Johnson
At Janssen, we’re making a future the place illness is a factor of the previous. We are the Pharmaceutical Firms of Johnson & Johnson, working tirelessly to make that future a actuality for sufferers in all places by preventing illness with science, enhancing entry with ingenuity and therapeutic hopelessness with coronary heart. We deal with areas of drugs the place we are able to make the most important distinction: Cardiovascular & Metabolism, Immunology, Infectious Ailments & Vaccines, Neuroscience, Oncology and Pulmonary Hypertension.

Be taught extra at www.janssen.com. Comply with us at www.twitter.com/JanssenGlobal and www.twitter.com/JanssenUS. Janssen Analysis & Improvement, LLC and Janssen Biotech, Inc. are a part of the Janssen Pharmaceutical Firms of Johnson & Johnson.

DuoBody^® is a registered trademark of Genmab A/S.

Cautions Regarding Ahead-Wanting Statements

This press launch incorporates “forward-looking statements” as outlined within the Non-public Securities Litigation Reform Act of 1995 concerning product improvement and the potential advantages and remedy impression of amivantamab and lazertinib. The reader is cautioned to not depend on these forward-looking statements. These statements are primarily based on present expectations of future occasions. If underlying assumptions show inaccurate or identified or unknown dangers or uncertainties materialize, precise outcomes may fluctuate materially from the expectations and projections of Janssen Analysis & Improvement, LLC or any of the opposite Janssen Pharmaceutical Firms and/or Johnson & Johnson. Dangers and uncertainties embrace, however are usually not restricted to: challenges and uncertainties inherent in product analysis and improvement, together with the uncertainty of medical success and of acquiring regulatory approvals; uncertainty of business success; manufacturing difficulties and delays; competitors, together with technological advances, new merchandise and patents attained by opponents; challenges to patents; product efficacy or security issues leading to product remembers or regulatory motion; adjustments in habits and spending patterns of purchasers of well being care services and products; adjustments to relevant legal guidelines and laws, together with international well being care reforms; and tendencies towards well being care value containment. An additional record and descriptions of those dangers, uncertainties and different elements could be present in Johnson & Johnson’s Annual Report on Kind 10-Okay for the fiscal 12 months ended December 29, 2019, together with within the sections captioned “Cautionary Be aware Concerning Ahead-Wanting Statements” and “Merchandise 1A. Danger Elements,” and within the firm’s most not too long ago filed Quarterly Report on Kind 10-Q, and the corporate’s subsequent filings with the Securities and Change Fee. Copies of those filings can be found on-line at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Not one of the Janssen Pharmaceutical Firms nor Johnson & Johnson undertakes to replace any forward-looking assertion on account of new data or future occasions or developments.

¹ Grugan et al. MAbs. 2017;9(1):114-126.
² Moores et al. Most cancers Res. 2016;76(13)(suppl 27216193):3942-3953.
³ Yun et al. Most cancers Discov. 2020;10(8):1194-1209.
⁴ Vijayaraghavan et al. Mol Most cancers Ther. 2020;19(10):2044-2056.
⁵ Janssen Submits Utility to U.S. FDA Searching for Approval of Amivantamab for the Therapy of Sufferers with Metastatic Non-Small Cell Lung Most cancers with EGFR Exon 20 Insertion Mutations. https://www.jnj.com/janssen-submits-application-to-u-s-fda-seeking-approval-of-amivantamab-for-the-treatment-of-patients-with-metastatic-non-small-cell-lung-cancer-with-egfr-exon-20-insertion-mutations. Accessed January 2021. 
⁶ Remon, J et al. EGFR exon 20 insertions in superior non-small cell lung most cancers: A brand new historical past begins. Most cancers Therapy Evaluations. 90 (2020).
⁷ The World Well being Group. Most cancers. Out there at: https://www.who.int/news-room/fact-sheets/detail/cancer. Accessed January 2021.
⁸ American Most cancers Society. What’s Lung Most cancers? Out there at: https://www.cancer.org/content/cancer/en/cancer/lung-cancer/about/what-is.html. Accessed January 2021.
⁹ Dersarkissian M, Bhak R, Lin H, Li S, Cheng M, Lax A, et al. Actual-World Therapy Patterns and Survival in Non-Small Cell Lung Most cancers Sufferers with EGFR Exon 20 Insertion Mutations. Summary introduced at: World Convention on Lung Most cancers; Sep 9, 2019; Barcelona, Spain.
¹⁰ Ramalingam SS, Vansteenkiste J, Planchard D, Cho BC, Grey JE, Ohe Y, et al. General Survival with Osimertinib in Untreated, EGFR-Mutated Superior NSCLC. N Engl J Med. 2020 Jan 2;382(1):41-50.
¹¹ Park, Okay. et al. Amivantamab, an Anti-EGFR-MET Bispecific Antibody, in Sufferers with EGFR Exon 20 Insertion-Mutated NSCLC. https://meetinglibrary.asco.org/record/184802/abstract. Accessed January 2021.
¹² Olsen D, et al. Companion diagnostics for focused most cancers medicine – medical and regulatory facets. Entrance Oncol. 2014;4:105. Revealed 2014 Could 16. doi:10.3389/fonc.2014.00105.
¹³ Ahn, J. et al. Lazertinib in sufferers with EGFR mutation-positive superior non-small-cell lung most cancers: outcomes from the dose escalation and dose enlargement components of a first-in-human, open-label, multicentre, part 1–2 examine. Lancet Oncology. 2019. 20 (12):  1681-1690.
¹⁴ ClinicalTrials.gov. Examine of JNJ-61186372, a Human Bispecific EGFR and cMet Antibody, in Contributors With Superior Non-Small Cell Lung Most cancers. Out there at: https://clinicaltrials.gov/ct2/show/NCT02609776. Accessed January 2021.
¹⁵ Clinicaltrials.gov. Medical Trial of YH25448 in Sufferers With EGFR Mutation Optimistic Superior NSCLC. https://clinicaltrials.gov/ct2/show/NCT03046992 . Accessed January 2021.
¹⁶ Oxnard, JR et. al. Pure historical past and molecular traits of lung cancers harboring EGFR exon 20 insertions. J Thorac Oncol. 2013 Feb;8(2):179-84. doi: 10.1097/JTO.0b013e3182779d18.
¹⁷ Zhang et al 2016 (Oncotarget, Vol. 7, No. 48) examine which estimated prevalence of EGFR mutations throughout varied affected person subgroups, together with Asians.
¹⁸ Howlader N, Noone AM, Krapcho M, Miller D, Brest A, Yu M, Ruhl J, Tatalovich Z, Mariotto A, Lewis DR, Chen HS, Feuer EJ, Cronin KA (eds). SEER Most cancers Statistics Assessment, 1975-2016, Nationwide Most cancers Institute. Bethesda, MD, https://seer.cancer.gov/csr/1975_2016/, primarily based on November 2018 SEER knowledge submission, posted to the SEER site.
¹⁹ Lin JJ, Cardarella S, Lydon CA, Dahlberg SE, Jackman DM, Jänne PA, et al. 5-12 months Survival in EGFR-Mutant Metastatic Lung Adenocarcinoma Handled with EGFR-TKIs. J Thorac Oncol. 2016 Apr;11(4):556-65.

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