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

January 12, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that eight company-sponsored presentations, including two oral presentations, will be featured at the International Association for the Study of Lung Cancer’s (IASLC) 2020 World Conference on Lung Cancer (WCLC) Singapore taking place virtually January 28-31, 2021. The presentations include updated data from the Phase 1 CHRYSALIS study (NCT02609776) evaluating amivantamab in patients with NSCLC and EGFR exon 20 insertion mutations and two studies that characterize the high unmet need and lack of standard of care in patients with exon 20 insertion mutations and the underdiagnosis of these patients in real-world settings.

Amivantamab is an investigational, fully human bispecific antibody that targets tumors by directing immune cell activity against tumors with activating and resistance EGFR mutations and mesenchymal epithelial transition factor (MET) mutations and amplifications.[i],[ii],[iii],[iv] Janssen has filed regulatory submissions in the U.S. and Europe seeking approval of amivantamab for the treatment of patients with NSCLC and EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.[v] These applications mark the first-ever regulatory submissions of a treatment for patients with NSCLC and EGFR exon 20 insertion mutations.[vi]

“We see an important opportunity to improve the diagnosis and treatment of patients with EGFR-mutated non-small cell lung cancer, especially for individuals with exon 20 insertion mutations. To that end, we look forward to presenting data highlighting the potential of amivantamab in this patient population, and the importance of genetic testing to identify mutations that may impact treatment outcomes,” said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC. “We are focused and committed to transforming the trajectory of lung cancer through improved diagnostics, novel therapeutics and interception strategies.”

Lung cancer is one of the most common cancers and is the leading cause of cancer deaths worldwide, with NSCLC making up 80 to 85 percent of all lung cancers.[vii],[viii] Patients with EGFR exon 20 insertion mutations have a median survival of less than 17 months[ix], which is much shorter than patients with EGFR exon 19 deletions or L858R mutations, who have a median survival of 32-39 months on current therapies.[x]

Amivantamab Phase 1 CHRYSALIS Study Shows Promise for Patients with NSCLC and EGFR Exon 20 Insertion Mutations
New data from the Phase 1 CHRYSALIS study evaluating the safety and efficacy of amivantamab in patients with metastatic NSCLC and EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy will be presented as an oral presentation (Abstract #3031). Early results from the CHRYSALIS study were presented at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program (Abstract #9512).[xi]

Mini-Oral Presentation Underscores Unmet Need of Patients with EGFR Exon 20 Insertion Mutations
A mini-oral presentation based on real-world data will provide new insights into the differences in prognoses for patients with NSCLC and EGFR exon 20 insertion mutations compared to those with other EGFR mutations (Abstract #3390).

Real-World Datasets Spotlight Underdiagnosis for Patients with Lung Cancer with Genetic Alterations
Accurate identification of driver mutations is an important part of lung cancer diagnostic and staging processes.[xii] A new analysis of real-world genomic data that will be presented at the meeting (Abstract #3399) estimates that genetic tests using polymerase chain reaction (PCR) may miss up to 50 percent of tumors with EGFR exon 20 insertion mutations, suggesting significant underdiagnosis exists.

Further details about these data and the science that Janssen is advancing for patients with lung cancer will be made available throughout the IASLC 2020 WCLC via the Janssen Oncology Virtual Newsroom.

Company-sponsored abstracts to be presented at the meeting include:

Abstract No.

Title

Date/Time

Oral Presentation

Abstract #3031

Amivantamab, an EGFR-MET Bispecific Antibody, in EGFR Exon 20 Insertion Mutant Non-Small Cell Lung Cancer

Thursday, January 28th

10:55 pm – 11:05 pm EST / Friday, January 29th 11:55 am – 12:05 pm Singapore Standard Time (SST)

Mini-Oral Presentation

Abstract #3390

Comparative Clinical Outcomes for Patients with NSCLC Harboring EGFR Exon 20 Insertion Mutations and Common EGFR Mutations

Friday, January 29th

4:20 am – 4:25 am EST / Friday, January 29th 5:20 pm – 5:25 pm SST

Featured Poster

Abstract #3399

Underdiagnosis of EGFR Exon 20 Insertion Mutation Variants: Estimates from NGS-Based Real-World Datasets

Thursday, January 28th EST / Friday, January 29th SST

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Poster Displays

Abstract #3380

PAPILLON: Randomized Phase 3 Study of Amivantamab Plus Chemotherapy vs Chemotherapy Alone in EGFR Exon20ins NSCLC

Thursday, January 28th EST / Friday, January 29th SST

Abstract #1247

Cardiac Safety Assessment of Lazertinib in Patients with EGFR Mutation-Positive Advanced NSCLC

Thursday, January 28th EST / Friday, January 29th SST

Abstract #1405

A Phase 1/1b Study of Lazertinib as Monotherapy and in Combination with Amivantamab in Advanced EGFR-Mutated NSCLC

Thursday, January 28th EST / Friday, January 29th SST

Abstract #3374

MARIPOSA: Randomized Phase 3 Study of First-Line Amivantamab + Lazertinib vs Osimertinib vs Lazertinib in EGFR-Mutant NSCLC

Thursday, January 28th EST / Friday, January 29th SST

Abstract #1271

Epidemiological and Clinical Burden of EGFR Exon 20 Insertion in Advanced NSCLC: Results of a Systematic Literature Review

Thursday, January 28th EST / Friday, January 29th SST

About Amivantamab
Amivantamab is an investigational, fully human EGFR-MET bispecific antibody with immune cell-directing activity that targets tumors with activating and resistance EGFR mutations and MET mutations and amplifications.1,2,3,4 Companion diagnostics using Next Generation Sequencing, which are necessary to identify patients with EGFR exon 20 insertion mutations, have been an integral part of the development program for amivantamab. The bispecific antibody is being studied as a monotherapy in patients with EGFR exon 20 insertion mutations. Amivantamab is also being studied in combination with lazertinib, a third-generation tyrosine kinase inhibitor (TKI)[xiii], in adult patients with advanced NSCLC.[xiv] The production and development of the antibody followed Janssen Biotech, Inc.’s licensing agreement with Genmab for use of its DuoBody® technology platform.

About Lazertinib
Lazertinib is an oral, third-generation, brain-penetrant EGFR TKI that targets both the T790M mutation and activating EGFR mutations while sparing wild type-EGFR.[xv] Interim safety and efficacy results from the lazertinib Phase 1-2 study were published in The Lancet Oncology in 2019. In 2018, Janssen Biotech, Inc. entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib.

About Non-Small Cell Lung Cancer (NSCLC)
Worldwide, lung cancer is one of the most common cancers, and NSCLC makes up 80 to 85 percent of all lung cancers.7,8 The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma and large cellcarcinoma.8 Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase supporting cell growth and division.[xvi] EGFR mutations are present in 10 to 15 percent of patients with NSCLC and occur in 40 to 50 percent of Asian patients who have NSCLC.[xvii] The five-year survival rate for all patients with metastatic NSCLC and EGFR mutations treated with EGFR TKIs is less than 20 percent.[xviii],[xix] Estimated median overall survival for patients with NSCLC and EGFR exon 20 insertion mutations is shorter than in patients with common EGFR mutations.16

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. Follow us at www.twitter.com/JanssenGlobal and www.twitter.com/JanssenUS. Janssen Research & Development, LLC 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 and lazertinib. 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 materialize, 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.

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[i] Grugan et al. MAbs. 2017;9(1):114-126.
[ii] Moores et al. Cancer Res. 2016;76(13)(suppl 27216193):3942-3953.
[iii] Yun et al. Cancer Discov. 2020;10(8):1194-1209.
[iv] Vijayaraghavan et al. Mol Cancer Ther. 2020;19(10):2044-2056.
[v] 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. 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.
[vi] Remon, J et al. EGFR exon 20 insertions in advanced non-small cell lung cancer: A new history begins. Cancer Treatment Reviews. 90 (2020).
[vii] The World Health Organization. Cancer. Available at: https://www.who.int/news-room/fact-sheets/detail/cancer. Accessed January 2021.
[viii] American Cancer Society. What is Lung Cancer? Available at: https://www.cancer.org/content/cancer/en/cancer/lung-cancer/about/what-is.html. Accessed January 2021.
[ix] Dersarkissian M, Bhak R, Lin H, Li S, Cheng M, Lax A, et al. Real-World Treatment Patterns and Survival in Non-Small Cell Lung Cancer Patients with EGFR Exon 20 Insertion Mutations. Abstract presented at: World Conference on Lung Cancer; Sep 9, 2019; Barcelona, Spain.
[x] 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.
[xi] 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 January 2021.
[xii] Olsen D, et al. Companion diagnostics for targeted cancer drugs – clinical and regulatory aspects. Front Oncol. 2014;4:105. Published 2014 May 16. doi:10.3389/fonc.2014.00105.
[xiii] 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.
[xiv] 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 January 2021.
[xv] Clinicaltrials.gov. Clinical Trial of YH25448 in Patients With EGFR Mutation Positive Advanced NSCLC. https://clinicaltrials.gov/ct2/show/NCT03046992 . Accessed January 2021.
[xvi] 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.
[xvii] Zhang et al 2016 (Oncotarget, Vol. 7, No. 48) study which estimated prevalence of EGFR mutations across various patient subgroups, including Asians.
[xviii] 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 Cancer Statistics Review, 1975-2016, National Cancer Institute. Bethesda, MD, https://seer.cancer.gov/csr/1975_2016/, based on November 2018 SEER data submission, posted to the SEER web site.
[xix] Lin JJ, Cardarella S, Lydon CA, Dahlberg SE, Jackman DM, Jänne PA, et al. Five-Year Survival in EGFR-Mutant Metastatic Lung Adenocarcinoma Treated with EGFR-TKIs. J Thorac Oncol. 2016 Apr;11(4):556-65.

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