RYBREVANT plus chemotherapy demonstrates durable benefit with a differentiated approach that dual-targets
EGFR
and MET
Results mark significant progress for a
patient population with poor outcomes and a historical five-year survival rate of
just 8%
SEOUL, South Korea
,
Sept. 13, 2026
/PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced results from the final overall survival (OS) analysis of the Phase 3 PAPILLON study evaluating first-line intravenous (IV) RYBREVANT (amivantamab-vmjw) plus carboplatin-pemetrexed chemotherapy versus chemotherapy alone in patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (
EGFR
) exon 20 insertion (Ex20ins) mutations. Patients treated with the combination achieved a median OS of nearly three years (34.3 months), compared with 27.9 months for chemotherapy alone. The combination extended median OS by more than six months, despite 76 percent of eligible patients in the chemotherapy arm crossing over to second-line RYBREVANT after disease progression. This represents the longest reported median OS in this patient population, which is nearly twice the historical median.
1
These results were presented during the Presidential Symposium at the
International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC)
(Late-breaking Abstract #PL.03.03).
Resetting survival expectations for patients with historically poor outcomes
EGFR
exon 20 insertion mutations account for approximately 12 percent of all
EGFR
mutations.
2
Unlike more common
EGFR
mutations (exon 19 deletions and L858R), exon 20 insertion mutations have been difficult to treat with targeted medicines, leaving patients with few treatment options, challenging side effects and poorer outcomes.
3
Historically, median overall survival has ranged from approximately 16 to 24 months, with five-year survival reported at just eight percent.
4,5,6
RYBREVANT is a first-in-class bispecific antibody designed to dual-target
EGFR
and mesenchymal-epithelial transition (MET), two key drivers of tumor growth and treatment resistance, while also engaging the immune system.
7,8,9,10
It is currently approved for use in patients with
EGFR
-mutated advanced NSCLC across common (exon 19 deletions and exon 21 L858R substitution mutations) and exon 20 insertion mutations, in the first- and second-line settings.
11
Expert and company perspectives on longer survival in historically difficult-to-treat lung cancer
"We've come a long way in treating
EGFR
exon 20 insertion-positive lung cancer, and these results demonstrate the lasting impact RYBREVANT plus chemotherapy can have in helping patients live longer," said Dr. Chul Kim, M.D., M.P.H.,* Director of Thoracic Oncology, MedStar Georgetown University Hospital. "Patients are continuing treatment years after they started, which speaks to the durability of this approach and its value as a first-line treatment for this disease."
"We have long believed RYBREVANT could transform the outlook for patients with
EGFR
-mutated lung cancer by addressing key drivers of disease progression and treatment resistance," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "With the longest survival seen in this patient population, these results add to the growing body of evidence across common, atypical and exon 20 insertion
EGFR
mutations and further establish the regimen as a backbone therapy."
Detailed overall survival results
In the protocol-specified final analysis, RYBREVANT plus chemotherapy demonstrated a median OS of nearly three years (34.3 months) compared to approximately two years (27.9 months) for chemotherapy alone (hazard ratio [HR], 0.87; 95 percent confidence interval [CI], 0.66-1.14;
P
=0.307). A prespecified analysis accounting for crossover to RYBREVANT in the chemotherapy arm showed a significant overall survival benefit with RYBREVANT plus chemotherapy, reducing the risk of death by 43 percent (HR, 0.57; 95 percent CI, 0.39-0.82; nominal
P
=0.003).
1
Long-term follow-up provides further evidence of durable benefit, with RYBREVANT plus chemotherapy extending progression-free survival through second disease progression (PFS2) by more than 10 months compared with chemotherapy alone (28.3 vs. 17.5 months; HR, 0.59; 95 percent CI, 0.45-0.77; nominal
P
2% of patients including dyspnea (3.1%), thrombocytopenia (3.1%), sepsis (2.3%), and PE (2.3%). Fatal ARs occurred in 2.3% of patients; these included respiratory failure, sepsis, and ventricular fibrillation (0.8% each).
In PAPILLON (n=151), the most common ARs (≥20%) were rash (90%), nail toxicity (62%), stomatitis (43%), IRRs (42%), fatigue (42%), edema (40%), constipation (40%), decreased appetite (36%), nausea (36%), COVID-19 (24%), diarrhea (21%), and vomiting (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased albumin (7%), increased alanine aminotransferase (4%), increased gamma-glutamyl transferase (4%), decreased sodium (7%), decreased potassium (11%), decreased magnesium (2%), and decreases in white blood cells (17%), hemoglobin (11%), neutrophils (36%), platelets (10%), and lymphocytes (11%).
In PAPILLON, serious ARs occurred in 37% of patients, with those occurring in ≥2% of patients including rash, pneumonia, ILD, PE, vomiting, and COVID-19. Fatal adverse reactions occurred in 7 patients (4.6%) due to pneumonia, cerebrovascular accident, cardio-respiratory arrest, COVID-19, sepsis, and death not otherwise specified.
RYBREVANT as a Single Agent
In CHRYSALIS (n=129), the most common ARs (≥20%) were rash (84%), IRR (64%), paronychia (50%), musculoskeletal pain (47%), dyspnea (37%), nausea (36%), fatigue (33%), edema (27%), stomatitis (26%), cough (25%), constipation (23%), and vomiting (22%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased lymphocytes (8%), decreased albumin (8%), decreased phosphate (8%), decreased potassium (6%), increased alkaline phosphatase (4.8%), increased glucose (4%), increased gamma-glutamyl transferase (4%), and decreased sodium (4%).
Serious ARs occurred in 30% of patients, with those occurring in ≥2% of patients including PE, pneumonitis/ILD, dyspnea, musculoskeletal pain, pneumonia, and muscular weakness. Fatal adverse reactions occurred in 2 patients (1.5%) due to pneumonia and 1 patient (0.8%) due to sudden death.
LAZCLUZE DRUG INTERACTIONS
Avoid concomitant use of LAZCLUZE with strong and moderate CYP3A4 inducers. Consider an alternate concomitant medication with no potential to induce CYP3A4.
Monitor for adverse reactions associated with a CYP3A4 or BCRP substrate where minimal concentration changes may lead to serious adverse reactions, as recommended in the approved product labeling for the CYP3A4 or BCRP substrate.
Please see full Prescribing Information for
RYBREVANT
FASPRO
,
RYBREVANT
and
LAZCLUZE
.
cp-491009v2
About Johnson & Johnson
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.
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 RYBREVANT
®
(amivantamab-vmjw). 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 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 most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at
,
,
or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.
* Dr. Chul Kim, M.D., M.P.H., has served as a consultant to Johnson & Johnson; he has not been paid for any media work.
†
RECIST (version 1.1) refers to Response Evaluation Criteria in Solid Tumors, which is a standard way to measure how well
solid tumors respond to treatment and is based on whether tumors shrink, stay the same or get bigger.
‡
The NCCN content does not constitute medical advice and should not be used in place of seeking professional medical advice, diagnosis or treatment by licensed practitioners. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
§
See the NCCN Guidelines for detailed recommendations, including other treatment options.
||
The NCCN Guidelines for NSCLC provide recommendations for certain individual biomarkers that should be tested and recommend testing techniques but do not endorse any specific commercially available biomarker assays or commercial laboratories.
Source: Johnson & Johnson
1
Kim C, et al. First-line amivantamab-chemotherapy vs chemotherapy in NSCLC with
EGFR
exon 20 insertions: Overall survival from PAPILLON. Presented at: IASLC 2026 World Conference on Lung Cancer; 2026; Seoul.
2
Arcila ME, Nafa K, Chaft JE, et al.
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2013;12(2):220-229.
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BioDrugs
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Ou SI, et al. Real-world response and outcomes in patients with NSCLC with
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JTO Clin Res Rep
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Bazhenova L, et al. Comparative clinical outcomes for patients with advanced NSCLC harboring
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Lung Cancer
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Target Oncol
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EGFR
inhibitor-resistant lung tumors.
Cancer Res
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8
Vijayaraghavan S, Lipfert L, Chevalier K, et al. Amivantamab (JNJ-61186372), an Fc enhanced
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Mol Cancer Ther
. 2020;19(10):2044-2056. doi:10.1158/1535-7163.MCT-20-0071
9
Yun J, Lee SH, Kim SY, et al. Antitumor activity of amivantamab (JNJ-61186372), an
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Cancer Discov
. 2020;10(8):1194-1209. doi:10.1158/2159-8290.CD-20-0116
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Soo R, et al. Asia-Pacific practical consensus in the management of adverse events related to amivantamab-based therapies in non-small cell lung cancer.
Lung Cancer
. Published online May 22, 2026. doi:10.1016/S0169-5002(26)00466-6.
11
RYBREVANT [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
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ClinicalTrials.gov. A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (
EGFR
) Exon 20 Insertions (PAPILLON). Accessed September 2026.
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The World Health Organization. Cancer. Accessed September 2026.
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. 2013 Feb;8(2):179-84. doi: 10.1097/JTO.0b013e3182779d18.
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Exon 20 Insertion Mutation Variants: Estimates from NGS-based Real World Datasets. 2021 World Conference on Lung Cancer Annual Meeting; January 29, 2021.
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Howlader N, et al. SEER Cancer Statistics Review, 1975-2016, National Cancer Institute. Bethesda, MD, based on November 2018 SEER data submission, posted to the SEER web site.
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26
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines
®
) for Non-Small Cell Lung Cancer V.7.2026 © National Comprehensive Cancer Network, Inc. All rights reserved. Accessed September 2026. To view the most recent and complete version of the guideline, go online to NCCN.org.
27
RYBREVANT
FASPRO
[Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
Media contact:
Oncology Media Relations
oncology_media_relations@its.jnj.com
Investor contact:
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