Johnson & Johnson's RYBREVANT®▼ (Amivantamab) Plus Chemotherapy Delivers Median Overall Survival Of Nearly Three Years In EGFR Exon 20 Insertion Mutation-Positive Non-Small Cell Lung Cancer

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• Amivantamab plus chemotherapy demonstrates durable benefit with a differentiated approach that dual targets EGFR and MET¹
• Median overall survival reached 34.3 months with the amivantamab-based regimen, the longest reported to date in this patient population^1,2

BEERSE, BELGIUM, Sept. 14, 2026 (GLOBE NEWSWIRE) -- Johnson & Johnson today announced results from the final overall survival (OS) analysis of the Phase 3 PAPILLON study evaluating first-line intravenous (IV) RYBREVANT^®▼ (amivantamab) 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 amivantamab plus chemotherapy achieved a median OS of 34.3 months.¹ The median OS with chemotherapy alone was 27.9 months (hazard ratio [HR], 0.87; 95% confidence interval [CI], 0.66–1.14; p=0.307).¹ The combination of amivantamab plus chemotherapy showed a numerical difference in median OS by more than six months, despite 76% of eligible patients in the chemotherapy arm crossing over to second-line amivantamab after disease progression.¹ This represents the longest reported median overall survival in this patient population, and is nearly twice the 16.2-month median OS reported in a real-world cohort of patients with EGFR exon 20 insertion-mutated NSCLC.^1,2

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 Ex20ins mutations account for approximately 12% of all EGFR mutations.² Unlike more common EGFR mutations (exon 19 deletions and L858R), exon 20 insertion mutations have thus far been difficult to treat with targeted medicines; leaving patients with few treatment options, challenging side effects and poorer outcomes.³ Historically, median OS has ranged from approximately 16 to 24 months, with five-year survival reported at just 8%.^1,2

Amivantamab 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.^4,5,6,7 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-line and second-line settings.⁸

Expert and company perspectives on survival advances 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 amivantamab 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 amivantamab 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.”

“For patients with EGFR exon 20 insertion-mutated non-small cell lung cancer, the treatment chosen at the outset can make a profound difference,” said Henar Hevia, Ph.D., EMEA Therapeutic Area Head, Oncology, Johnson & Johnson.“These long-term PAPILLON results demonstrate the longest reported median overall survival to date in this disease, highlighting the importance of early identification and ensuring patients can access the most effective treatment approach from the beginning. This represents meaningful progress for a patient population that has historically faced poor outcomes and limited targeted treatment options.”

Detailed overall survival results

In the protocol-specified final analysis, amivantamab plus chemotherapy demonstrated a median OS of 34.3 months.¹Chemotherapy alone had a median OS of 27.9 months (HR, 0.87; 95% CI, 0.66-1.14; p=0.307).¹ A prespecified analysis adjusting for treatment crossover showed a significant overall reduction in the risk of death by 43% (HR, 0.57; 95% CI, 0.39-0.82; nominal p=0.003).¹

Long-term follow-up provides further evidence of durable benefit, with amivantamab 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% CI, 0.45-0.77; nominal p<0.0001).¹ This benefit was observed in the context of 76% of eligible patients in the chemotherapy arm crossing over to second-line amivantamab after disease progression.¹ Twelve percent of patients remained on first-line treatment at the clinical cut-off date compared with no patients in the chemotherapy arm.¹ Patient-reported outcomes also favored the combination, delaying the worsening of several key lung cancer symptoms compared with chemotherapy alone.¹

The safety profile of IV amivantamab plus chemotherapy was consistent with previous reports from studies conducted before prophylactic strategies were introduced, with no new safety signals observed with longer follow-up.¹ The most common treatment-related adverse events occurring in at least 30% of patients included paronychia (60%), neutropenia (60%) and rash (58%).¹

These overall survival findings build on the primary PAPILLON analysis, which demonstrated a statistically significant and clinically meaningful 60% improvement in progression-free survival (primary endpoint) with first-line amivantamab plus chemotherapy versus chemotherapy alone in patients with EGFR exon 20 insertion mutation-positive advanced NSCLC.⁹ Clinical benefit in the primary analysis was consistent across key patient subgroups, including patients with brain metastases, EGFR exon 20 insertion variants and TP53 co-mutations.⁹ Those results, which supported global approvals of the regimen in this setting, were simultaneously published in The New England Journal of Medicine.⁹

Additional data presented at WCLC 2026 highlight ongoing research across intravenous and subcutaneous amivantamab, including prophylactic strategies evaluated in the COPERNICUS study (Abstract #MO12.09) and subcutaneous administration evaluated in the PALOMA-2 study (Abstract #PT2.03.06).

About the PAPILLON study

PAPILLON (NCT04538664 ), which enrolled 308 patients, is a randomised, open-label Phase 3 study evaluating the efficacy and safety of amivantamab in combination with chemotherapy, compared with chemotherapy alone, in newly diagnosed patients with advanced or metastatic NSCLC characterised by EGFR exon 20 insertion mutations. The primary endpoint of the study is progression-free survival (PFS) (using RECIST v1.1 guidelines^§) as assessed by blinded independent central review (BICR).

About Amivantamab

Amivantamab is a fully-human EGFR-MET bispecific antibody that acts by targeting tumours with activating and resistance EGFR mutations and MET mutations and amplifications, and by harnessing the immune system.^4,6,10

The European Commission (EC) has approved amivantamab in the following indications:⁸

Amivantamab (intravenous and subcutaneous):

• In combination with lazertinib for the first-line treatment of adult patients with advanced non–small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations.
• In combination with carboplatin and pemetrexed for the treatment of adult patients with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations after failure of prior therapy, including an EGFR tyrosine kinase inhibitor (TKI).
• In combination with carboplatin and pemetrexed for the first-line treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations.
• As monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy.
• Subcutaneous (SC) amivantamab is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE^® drug delivery technology.¹¹
  

For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using amivantamab, please refer to the Summary of Product Characteristics.⁸

▼ In line with EU regulations for new medicines, amivantamab is subject to additional monitoring.

About Non-Small Cell Lung Cancer

In Europe, it is estimated that 484,306 people were diagnosed with lung cancer in 2022.¹² NSCLC accounts for 85 percent of all lung cancer cases.¹³ Lung cancer is Europe's biggest cancer killer, with more deaths than breast cancer and prostate cancer combined.¹²

The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma and large cell carcinoma.¹³ Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase controlling cell growth and division.^13,14 EGFR mutations are present in 10 to 15 percent of Western patients with NSCLC with adenocarcinoma histology and occur in 40 to 50 percent of Asian patients.^15,16,17,18 EGFR ex19del or EGFR exon 21 L858R mutations are the most common EGFR mutations.¹⁹ The five-year survival rate for all patients with advanced NSCLC and EGFR mutations treated with EGFR TKIs is less than 20 percent and between 25-32 percent of patients receiving the current first-line standard of care, osimertinib, do not survive long enough to reach second-line treatment.^{20,21,22,23,24,25,26} EGFR exon 20 insertion (ex20ins) mutations are the third most prevalent activating EGFR mutation.²⁷ Patients with EGFR ex20ins mutations have a real-world five-year OS of eight percent in the frontline setting, which is worse than patients with EGFR ex19del or L858R mutations, who have a real-world five-year OS of 19 percent.²¹

About Johnson & Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.

Learn more at . Follow us at .

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 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 behaviour 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, 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.

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* 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.

CP-602121
September 2026

References:
¹Kim C, et al. First-Line Amivantamab-chemotherapy vs Chemotherapy in NSCLC with EGFR Exon 20 Insertions: Overall Survival From PAPILLON. Presented at: 2026 World Lung Cancer Congress; 13 September 2026; Seoul.
² Bazhenova L, et al. Comparative clinical outcomes for patients with advanced NSCLC harboring EGFR exon 20 insertion mutations and common EGFR mutations. Lung Cancer. 2021 Dec;162:154-161. doi: 10.1016/j.lungcan.2021.10.020.
³ Brazel D, et al. Non-small Cell Lung Cancer with EGFR or HER2 Exon 20 Insertion Mutations: Diagnosis and Treatment Options. BioDrugs. 2022 Nov;36(6):717-729. doi: 10.1007/s40259-022-00556-4.
⁴ Moores SL, Chiu ML, Bushey BS, et al. A Novel Bispecific Antibody Targeting EGFR and cMet Is Effective against EGFR Inhibitor-Resistant Lung Tumors. Cancer Res. 2016;76(13):3942-3953. doi:10.1158/0008-5472.CAN-15-2833
⁵ Vijayaraghavan S, Lipfert L, Chevalier K, 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. doi:10.1158/1535-7163.MCT-20-0071
⁶ Yun J, Lee SH, Kim SY, 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. doi:10.1158/2159-8290.CD-20-0116
⁷ 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.
⁸ European Medicines Agency. Amivantamab Summary of Product Characteristics. February 2026. Available at: . Last accessed: September 2026.
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¹⁰ Grugan KD, 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.
¹¹ Leighl NB et al. Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor–Mutated Non–Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study. ASCO Journal of Clinical Oncology. 2024;42(3):3593-3605.
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