RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE® (lazertinib) delivers statistically significant and clinically meaningful improvement in overall survival benefit for Asian patients with EGFR-mutated ...

SINGAPORE, Dec. 8, 2025First and only chemotherapy-free combination in the first-line setting to demonstrate an overall survival benefit versus osimertinib among Asian patients.

Median overall survival not yet reached and is projected to exceed four years, which would surpass osimertinib monotherapy by more than one year.

/PRNewswire/ -- Johnson & Johnson today announced final overall survival (OS) results from the Asia patients of the Phase 3 MARIPOSA study. Head-to-head comparison data versus osimertinib monotherapy showed amivantamab plus lazertinib led to a clinically meaningful OS improvement in the first-line treatment of Asian patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations. Median OS for this chemotherapy-free regimen is projected to exceed four years, which would represent a more than one-year improvement compared to osimertinib alone. These results were presented during a proffered paper session at the European Society for Medical Oncology (ESMO) Asia Congress 2025 (Abstract #972O).^[1]

"Amivantamab plus lazertinib demonstrated a 26 percent lower risk of death compared to osimertinib monotherapy and is projected to extend survival well beyond what has historically been possible," said presenting author and lead trial investigator Dr. Hidetoshi Hayashi*, M.D., Ph.D., Department of Medical Oncology, Kindai University Faculty of Medicine in Osaka-Sakai, Japan. "For patients in Asia, where EGFR-mutated disease is highly prevalent, these findings establish the combination as an important new treatment that advances the standard of care in the first-line setting."

Asia has the largest population of patients with EGFR-mutated NSCLC worldwide, with an estimated prevalence of 30 to 40 percent compared to 10 to 15 percent in Europe and the United States.^[2] Despite treatment advances, approximately 30 percent of patients do not reach second-line therapy, making the choice of first treatment critical.^[3] Fewer than 20 percent of patients are alive five years after diagnosis.^[4]

Results from 501 participants who self-identified as Asian  in the MARIPOSA trial, showed those treated with amivantamab plus lazertinib had a 26 percent lower risk of death compared with osimertinib (hazard ratio [HR], 0.74; 95 percent confidence interval [CI], 0.56-0.97; nominal P=0.026), based on a median follow-up of 38.7 months. Median OS for the combination was not yet reached compared with 38.4 months for osimertinib (95 percent CI, 35.1-not reached). Survival projections suggest that amivantamab plus lazertinib could extend median OS to more than a year beyond that achieved with osimertinib. At three years, 61 percent of patients treated with the combination were alive compared with 53 percent of those receiving osimertinib. The survival advantage was maintained at 42 months, with survival rates of 59 percent and 46 percent, respectively, indicating a durable survival benefit with RYBREVANT + LAZCLUZE combination therapy in 1L. Secondary endpoints including disease progression in the brain and time to symptomatic progression were positive and consistent with results seen globally.^[1]

"These results give real proof that progress is being made for people living with EGFR-mutated lung cancer," said Kazuo Hasegawa**, Founder of Lung Cancer Patients Network ONE STEP. "For patients and families across Asia, where this disease is especially common, seeing survival extend beyond what once seemed possible brings hope for a different future."

"We're working to change the course of lung cancer by addressing its underlying biology," said Anthony Elgamal, Vice President of Oncology, Johnson & Johnson Innovative Medicine Asia Pacific. "By targeting the key EGFR and MET pathways that drive tumor growth and resistance while engaging the immune system, amivantamab plus lazertinib is delivering longer survival in the first-line setting and helping advance outcomes for patients across Asia."

The safety profile of amivantamab plus lazertinib was consistent with the overall MARIPOSA population and prior reports in Asian patients. No new safety concerns were observed. Most adverse reactions occurred early in treatment and were manageable with appropriate care. Among Asian participants, the most common Grade 3 or higher adverse events were rash (18 percent), dermatitis acneiform (9 percent), and paronychia (9 percent).^[1] Follow-up studies of amivantamab suggest that using preemptive or prophylactic measures can help lower the overall number and severity of skin reactions, infusion-related reactions, and venous thromboembolic events.^[5,6,7,8]

The combination of amivantamab and lazertinib is approved in the United States, Europe and the Asia-Pacific region in the Japan, China, Australia, Singapore, Korea and Taiwan market for first-line treatment for patients with EGFR-mutated NSCLC based on the global MARIPOSA Phase 3 study; additional markets in the Asia‑Pacific region are expected to follow shortly.

About the MARIPOSA Asia Cohort

The MARIPOSA Asia cohort is part of the global, randomized, Phase 3 MARIPOSA study (NCT04487080) evaluating amivantamab in combination with lazertinib versus osimertinib monotherapy in the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations. The Asia cohort enrolled 501 patients who self-identified as Asian, majority of whom were based in the Asia Pacific region. The primary endpoint was progression-free survival (PFS), with secondary endpoints including overall survival (OS), objective response rate (ORR), duration of response (DOR), and intracranial PFS, as assessed by blinded independent central review (BICR) using RECIST v1.1 criteria.^[9†]

About amivantamab

Amivantamab-vmjw, a fully-human bispecific antibody targeting EGFR and MET with immune cell-directing activity, is approved in the U.S., Europe and six markets in Asia-Pacific region in combination with lazertinib for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations.

Amivantamab is approved in the U.S., Europe and thirteen markets in Asia-Pacific region in combination with chemotherapy (carboplatin-pemetrexed) for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR TKI.

Amivantamab is approved in the U.S., Europe and thirteen markets in Asia-Pacific region in combination with chemotherapy (carboplatin and pemetrexed) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.

Amivantamab is approved in the U.S., Europe and twelve markets in Asia-Pacific region as monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.

The legal manufacturer for amivantamab is Janssen Biotech, Inc.

About lazertinib

In 2018, Janssen Biotech, Inc., entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib (marketed as LECLAZA in South Korea). 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. An analysis of the efficacy and safety of lazertinib from the Phase 3 LASER301 study was published in The Journal of Clinical Oncology in 2023.^[10]

The legal manufacturer for lazertinib is Janssen Biotech, Inc and Yuhan Corporation.

About Non-Small Cell Lung Cancer

Worldwide, lung cancer is one of the most common cancers, with NSCLC making up 80 to 85 percent of all lung cancer cases.^[11,12]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.^[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.^{[11,12,15,16,17,18]}EGFR ex19del or EGFR L858R mutations are the most common EGFR mutations.^[19] The five-year survival rate for all people with advanced NSCLC and EGFR mutations treated with EGFR TKIs is less than 20 percent.^[20,21] EGFR exon 20 insertion mutations are the third most prevalent activating EGFR mutation.^[22]Patients with EGFR exon 20 insertion mutations have a real-world five-year overall survival (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.^[23] By comparison, other common cancers, such as breast and prostate cancer have a 5-year real world OS of 90 percent and 97 percent respectively.^[24]

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 https://www.jnj.com or at http://www.innovativemedicine.jnj.com/. Follow us at @JNJInnovMed. Johnson & Johnson International (Singapore) Pte. Ltd. is a Johnson & Johnson company.

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 or 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 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 http://www.sec.gov, http://www.jnj.com, 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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