{"id":32549,"date":"2025-09-12T12:11:30","date_gmt":"2025-09-12T05:11:30","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=32549"},"modified":"2025-09-12T12:11:30","modified_gmt":"2025-09-12T05:11:30","slug":"asia-cohort-of-phase-3-mariposa-study-shows-rybrevant-amivantamab-vmjw-plus-lazcluze-lazertinib-achieved-statistically-significant-and-clinically-meaningful-improvement-in-overall-surv","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=32549","title":{"rendered":"Asia cohort of Phase 3 MARIPOSA study shows RYBREVANT\u00ae (amivantamab-vmjw) plus LAZCLUZE\u00ae (lazertinib) achieved statistically significant and clinically meaningful improvement in overall survival versus osimertinib in EGFR-mutated non-small cell lung cancer"},"content":{"rendered":"\n\n\n
\"\"<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Median overall survival in Asia<\/span> cohort is projected to exceed four years, demonstrating a durable benefit and surpassing osimertinib monotherapy by more than one year<\/i><\/p>\n

First and only chemotherapy-free combination in the first line setting to show survival improvement of this magnitude in a population with the highest-prevalence of EGFR-mutated lung cancer<\/i><\/p>\n

SINGAPORE<\/span><\/span>, Sept. 12, 2025<\/span><\/span> \/PRNewswire\/ —\u00a0Johnson & Johnson today<\/span> announced positive\u00a0topline results for overall survival (OS) from the Asia<\/span> cohort of the Phase 3 MARIPOSA study, evaluating amivantamab plus lazertinib as a first-line therapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR<\/i>) exon 19 deletions (ex19del) or L858R substitution mutations. In this cohort, where EGFR<\/i> mutations are more common than in other regions, the chemotherapy-free combination met the final pre-specified secondary endpoint of OS and showed a clinically meaningful and statistically significant survival benefit over osimertinib monotherapy. Median OS improvement is projected to exceed four years, surpassing osimertinib monotherapy by more than one year.<\/p>\n

\n<\/div>\n

Asia<\/span> has the largest population of patients with EGFR<\/i>-mutated NSCLC worldwide, with an estimated prevalence of 30 to 40 percent compared to 10 to 15 percent in Europe<\/span> and the United States<\/span>.[1]<\/sup> Despite treatment advances, approximately 30 percent of patients do not reach second-line therapy, making the choice of first treatment critical.[2]<\/sup> Fewer than 20 percent of patients are alive five years after diagnosis.[3]<\/sup><\/p>\n

“EGFR<\/i>-mutated NSCLC is more common in Asia Pacific<\/span> than in other regions, which makes outcomes from the first treatment especially important,” said Byoung Chul Cho<\/span>, M.D., Ph.D., Professor of Division of Medical Oncology, Yonsei Cancer Center, Yonsei University<\/span> College of Medicine.* “Because of rapid disease progression and health system challenges, many patients will not have the chance to receive a second-line therapy. Therefore, the first treatment determines how the disease progresses over time. The MARIPOSA Asia<\/span> cohort results show that survival can be significantly extended with amivantamab plus lazertinib in patients of Asian descent, helping them live longer.”<\/p>\n

“For patients and families, every additional year means more time together and the chance to reach milestones that once felt out of reach,” said Kazuo Hasegawa<\/span>, Founder of Lung Cancer Patients Network ONE STEP.** “The MARIPOSA Asia<\/span> cohort results matter because they show that extending survival is possible in a disease where progress has often been measured in months.”<\/p>\n

“Overall survival is the most meaningful measure of progress, and the MARIPOSA Asia<\/span> cohort results reinforce the role of therapeutic innovations like amivantamab plus lazertinib in the first-line setting,” said Anthony Elgamal<\/span>, Vice President of Oncology, Johnson & Johnson Innovative Medicine Asia Pacific. “With its triple mode of action targeting EGFR<\/i> and MET while also activating immune cells, amivantamab plus lazertinib addresses resistance that often limits tyrosine kinase inhibitor based therapy and delivers durable survival. These findings, with a median overall survival projected beyond four years, mark an important milestone for patients across Asia<\/span>.”<\/p>\n

MARIPOSA<\/a>, which enrolled 1,074 patients, is a randomized, Phase 3 study evaluating amivantamab in combination with lazertinib versus osimertinib as a first-line treatment of patients with EGFR<\/i>-mutated NSCLC. The primary endpoint was progression-free survival (PFS) (using RECIST v1.1 guidelines\u00a7<\/sup>) as assessed by blinded independent central review (BICR). Secondary endpoints included OS, objective response rate (ORR), duration of response (DOR), second progression-free survival (PFS2) and intracranial PFS.[4]<\/sup><\/p>\n

The safety profile of amivantamab plus lazertinib was consistent with the primary analysis and no new safety signals emerged with longer-term follow-up. Phase 2 amivantamab studies suggest that using prophylactic measures can help lower the risk of adverse events such as skin reactions, infusion-related reactions and venous thromboembolic events.[5],[6],[7]<\/sup><\/p>\n

Overall survival results from the Asia<\/span> cohort will be presented at an upcoming congress. The combination of amivantamab and lazertinib is approved in the United States<\/span>, Europe<\/span> and the Asia-Pacific<\/span> region in the Japan<\/span>, <\/span>China<\/span>, Australia<\/span>, Korea and Taiwan<\/span> markets for first-line treatment for patients with\u00a0EGFR<\/i>-mutated NSCLC based on the global MARIPOSA Phase 3 study.\u00a0<\/p>\n

About\u00a0amivantamab\u00a0<\/b>\u00a0<\/p>\n

Amivantamab-vmjw, a fully-human bispecific antibody targeting EGFR<\/i> and MET with immune cell-directing activity, is approved in the U.S.,<\/a>\u00a0Europe<\/span><\/a>\u00a0and five countries and markets in\u00a0Asia-Pacific region\u00a0in combination with lazertinib for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR<\/i> exon 19 deletions or exon 21 L858R substitution mutations.<\/p>\n

Amivantamab is approved in the U.S.<\/a>, Europe<\/span><\/a>\u00a0and nine countries and markets in Asia-Pacific<\/span> region\u00a0in combination with chemotherapy (carboplatin-pemetrexed) for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR<\/i> exon 19 deletions or L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR<\/i> TKI.<\/p>\n

Amivantamab\u00a0is approved in the U.S.<\/a>, Europe<\/span><\/a>\u00a0and eleven countries and markets in Asia-Pacific<\/span> region\u00a0in combination with chemotherapy (carboplatin and pemetrexed) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR<\/i> exon 20 insertion mutations. \u00a0<\/p>\n

Amivantamab is approved in the U.S.<\/a>, Europe<\/span><\/a>\u00a0and\u00a0twelve countries and markets in Asia-Pacific<\/span> region as monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR<\/i> exon 20 insertion mutations.\u00a0<\/p>\n

About <\/b>lazertinib<\/b><\/p>\n

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<\/span>). Lazertinib is an oral, third-generation, brain-penetrant EGFR<\/i> TKI that targets both the T790M mutation and activating EGFR<\/i> mutations while sparing wild-type EGFR<\/i>. An analysis of the efficacy and safety of lazertinib from the Phase 3 LASER301 study was published in The Journal of Clinical Oncology<\/a><\/i> in 2023.[8]<\/sup><\/p>\n

About Non-Small Cell Lung Cancer<\/b><\/p>\n

Worldwide, lung cancer is one of the most common cancers, with NSCLC making up 80 to 85 percent of all lung cancer cases.[9]<\/sup>,<\/sup>[10] The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma.[11] <\/sup>Among the most common driver mutations in NSCLC are alterations in EGFR<\/i>, which is a receptor tyrosine kinase controlling cell growth and division.[12]<\/sup> EGFR<\/i> 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.[12],[13],[14],[15],[16] <\/sup>EGFR<\/i> ex19del or EGFR<\/i> L858R mutations are the most common EGFR<\/i> mutations.[17]<\/sup> The five-year survival rate for all people with advanced NSCLC and EGFR<\/i> mutations treated with EGFR<\/i> TKIs is less than 20 percent.[18],[19]<\/sup> EGFR<\/i> exon 20 insertion mutations are the third most prevalent activating EGFR<\/i> mutation.[20]<\/sup> Patients with EGFR<\/i> 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<\/i> ex19del or L858R mutations, who have a real-world five-year OS of 19 percent.[21]<\/sup> 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.[22]<\/sup><\/p>\n

About Johnson & Johnson\u00a0<\/b><\/p>\n

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<\/a> or at http:\/\/www.innovativemedicine.jnj.com\/<\/a>. Follow us at @JNJInnovMed<\/a>. Johnson & Johnson International (Singapore<\/span>) Pte. Ltd is a Johnson & Johnson company.<\/p>\n

Cautions Concerning Forward-Looking Statements\u00a0 <\/i><\/b><\/p>\n

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\u202fJohnson & 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\u202fJohnson & 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<\/a>, http:\/\/www.jnj.com<\/a>, or on request from\u202fJohnson & Johnson. Johnson & Johnson does not\u202fundertake to update any forward-looking statement as a result of new information or future events or developments.\u202f\u202f\u202f\u202f\u202f\u202f<\/i>\u00a0<\/p>\n

*Professor Byoung Chul Cho\u00a0has not been paid for any media work.<\/p>\n

**Mr. Kazuo Hasegawa<\/span> has served as a consultant to J&J; he has not been paid for any media work.<\/p>\n

\u00a7 <\/sup>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.<\/p>\n

\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\n

[1] <\/sup>Zhang YL, Yuan JQ, Wang KF, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget. 2016;7(48):78985-78993. doi:10.18632\/oncotarget.12587<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[2]<\/sup>\u00a0Roeper J, et al. Risk of not receiving 2nd line therapy is high in EGFR mt+ pts: Real world data of certified lung cancer centers on treatment sequence in EGFR mt+ pts. J Clin Oncol. 2018;36(suppl):e21220. doi:10.1200\/JCO.2018.36.15_suppl.e21220<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[3]<\/sup>\u00a0Sabari JK, Yu HA, Mahadevia PJ, et al. Overall survival in EGFR-mutant advanced non\u2013small cell lung cancer treated with first-line osimertinib: a cohort study integrating clinical and biomarker data in the United States. J Thorac Oncol. Published online May 2, 2025. doi:10.1016\/j.jtho.2025.04.010<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[4]<\/sup> ClinicalTrials.gov. A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (MARIPOSA). https:\/\/classic.clinicaltrials.gov\/ct2\/show\/NCT04487080. Accessed September 2025.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[5]<\/sup> Girard, et al. Preventing Moderate to Severe Dermatologic Adverse Events in First-line EGFR-mutant Advanced NSCLC Treated with Amivantamab Plus Lazertinib: Early Success of the COCOON Trial. 2025 European Lung Cancer Congress. March 27, 2025.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[6]<\/sup> Spira AI, et al.\u00a0Preventing infusion-related reactions with intravenous amivantamab\u2014results from SKIPPirr, a phase 2 study: a brief report. J Thorac Oncol<\/i>. 2025;20(6):809-816.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[7]<\/sup> Leighl N, et al.\u00a0Subcutaneous 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. J Clin Oncol<\/i>. 2024;42(30):3593-3605.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[8]<\/sup>\u00a0Cho BC, et al. Lazertinib versus gefitinib as first-line treatment in patients with EGFR-mutated advanced non-small-cell lung cancer: Results From LASER301. J Clin Oncol<\/i>. 2023;41(26):4208-4217.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[9]<\/sup>\u00a0The World Health Organization. Cancer.\u00a0https:\/\/www.who.int\/news-room\/fact-sheets\/detail\/cancer. Accessed\u00a0September 2025.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[10]\u00a0<\/sup>American Cancer Society. What is Lung Cancer? https:\/\/www.cancer.org\/content\/cancer\/en\/cancer\/lung-cancer\/about\/what-is.html. Accessed\u00a0September 2025.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[11]<\/sup> Oxnard JR, et al. Natural history and molecular characteristics of lung cancers harboring EGFR exon 20 insertions. J Thorac Oncol<\/i>. 2013;8(2):179-84. doi: 10.1097\/JTO.0b013e3182779d18.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[12]<\/sup> Bauml JM, et al. Underdiagnosis of EGFR Exon 20 Insertion Mutation Variants: Estimates from NGS-based Real World Datasets. 2021 World Conference on Lung Cancer Annual Meeting; January 29, 2021.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[13]<\/sup>\u00a0Pennell NA, et al. A phase II trial of adjuvant erlotinib in patients with resected epidermal growth factor receptor-mutant non-small cell lung cancer. J Clin Oncol<\/i>. 37:97-104.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[14]<\/sup>\u00a0Burnett H, et al. Epidemiological and clinical burden of EGFR exon 20 insertion in advanced non-small cell lung cancer: a systematic literature review. 2021 World Conference on Lung Cancer Annual Meeting; January 29, 2021.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[15]<\/sup>\u00a0Zhang YL, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget<\/i>. 2016;7(48):78985-78993.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[16]<\/sup>\u00a0Midha A, et al. EGFR mutation incidence in non-small-cell lung cancer of adenocarcinoma histology: a systematic review and global map by ethnicity. Am J Cancer Res<\/i>. 2015;5(9):2892-2911.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[17]<\/sup>\u00a0American Lung Association. EGFR and Lung Cancer.\u00a0https:\/\/www.lung.org\/lung-health-diseases\/lung-disease-lookup\/lung-cancer\/symptoms-diagnosis\/biomarker-testing\/egfr. Accessed\u00a0September 2025.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[18]<\/sup>\u00a0Howlader N, et al. SEER Cancer Statistics Review, 1975-2016, National Cancer Institute.\u00a0Bethesda, MD,\u00a0https:\/\/seer.cancer.gov\/csr\/1975_2016\/, based on\u00a0November 2018\u00a0SEER data submission, posted to the SEER web site.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[19]<\/sup>\u00a0Lin JJ, et al. Five-year survival in EGFR-mutant metastatic lung adenocarcinoma treated with EGFR-TKIs. J Thorac Oncol<\/i>. 2016;11(4):556-65.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[20]\u00a0<\/sup>Arcila, M. et al. EGFR exon 20 insertion mutations in lung adenocarcinomas: prevalence, molecular heterogeneity, and clinicopathologic characteristics.\u00a0Mol Cancer Ther<\/i>. 2013; 12(2):220-9.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[21]<\/sup>\u00a0Girard N, et al. Comparative clinical outcomes for patients with NSCLC harboring EGFR exon 20 insertion mutations and common EGFR mutations. Abstract presented at: World Conference on Lung Cancer Annual Meeting;\u00a0January 29, 2021; Singapore.\u00a0<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[22]<\/sup>\u00a0Surveillance, Epidemiology, and End Results (SEER) Program, National Cancer Institute, 2024.<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n

\u00a0<\/p>","protected":false},"excerpt":{"rendered":"

<\/p>\n\n\n\n
\"\"<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Median overall survival in Asia<\/span> cohort is projected to exceed four years, demonstrating a durable benefit and surpassing osimertinib monotherapy by more than one year<\/i><\/p>\n

First and only chemotherapy-free combination in the first line setting to show survival improvement of this magnitude in a population with the highest-prevalence of EGFR-mutated lung cancer<\/i><\/p>\n

SINGAPORE<\/span><\/span>, Sept. 12, 2025<\/span><\/span> \/PRNewswire\/ —\u00a0Johnson & Johnson today<\/span> announced positive\u00a0topline results for overall survival (OS) from the Asia<\/span> cohort of the Phase 3 MARIPOSA study, evaluating amivantamab plus lazertinib as a first-line therapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR<\/i>) exon 19 deletions (ex19del) or L858R substitution mutations. In this cohort, where EGFR<\/i> mutations are more common than in other regions, the chemotherapy-free combination met the final pre-specified secondary endpoint of OS and showed a clinically meaningful and statistically significant survival benefit over osimertinib monotherapy. Median OS improvement is projected to exceed four years, surpassing osimertinib monotherapy by more than one year.<\/p>\n

\n<\/div>\n

Asia<\/span> has the largest population of patients with EGFR<\/i>-mutated NSCLC worldwide, with an estimated prevalence of 30 to 40 percent compared to 10 to 15 percent in Europe<\/span> and the United States<\/span>.[1]<\/sup> Despite treatment advances, approximately 30 percent of patients do not reach second-line therapy, making the choice of first treatment critical.[2]<\/sup> Fewer than 20 percent of patients are alive five years after diagnosis.[3]<\/sup><\/p>\n

“EGFR<\/i>-mutated NSCLC is more common in Asia Pacific<\/span> than in other regions, which makes outcomes from the first treatment especially important,” said Byoung Chul Cho<\/span>, M.D., Ph.D., Professor of Division of Medical Oncology, Yonsei Cancer Center, Yonsei University<\/span> College of Medicine.* “Because of rapid disease progression and health system challenges, many patients will not have the chance to receive a second-line therapy. Therefore, the first treatment determines how the disease progresses over time. The MARIPOSA Asia<\/span> cohort results show that survival can be significantly extended with amivantamab plus lazertinib in patients of Asian descent, helping them live longer.”<\/p>\n

“For patients and families, every additional year means more time together and the chance to reach milestones that once felt out of reach,” said Kazuo Hasegawa<\/span>, Founder of Lung Cancer Patients Network ONE STEP.** “The MARIPOSA Asia<\/span> cohort results matter because they show that extending survival is possible in a disease where progress has often been measured in months.”<\/p>\n

“Overall survival is the most meaningful measure of progress, and the MARIPOSA Asia<\/span> cohort results reinforce the role of therapeutic innovations like amivantamab plus lazertinib in the first-line setting,” said Anthony Elgamal<\/span>, Vice President of Oncology, Johnson & Johnson Innovative Medicine Asia Pacific. “With its triple mode of action targeting EGFR<\/i> and MET while also activating immune cells, amivantamab plus lazertinib addresses resistance that often limits tyrosine kinase inhibitor based therapy and delivers durable survival. These findings, with a median overall survival projected beyond four years, mark an important milestone for patients across Asia<\/span>.”<\/p>\n

MARIPOSA<\/a>, which enrolled 1,074 patients, is a randomized, Phase 3 study evaluating amivantamab in combination with lazertinib versus osimertinib as a first-line treatment of patients with EGFR<\/i>-mutated NSCLC. The primary endpoint was progression-free survival (PFS) (using RECIST v1.1 guidelines\u00a7<\/sup>) as assessed by blinded independent central review (BICR). Secondary endpoints included OS, objective response rate (ORR), duration of response (DOR), second progression-free survival (PFS2) and intracranial PFS.[4]<\/sup><\/p>\n

The safety profile of amivantamab plus lazertinib was consistent with the primary analysis and no new safety signals emerged with longer-term follow-up. Phase 2 amivantamab studies suggest that using prophylactic measures can help lower the risk of adverse events such as skin reactions, infusion-related reactions and venous thromboembolic events.[5],[6],[7]<\/sup><\/p>\n

Overall survival results from the Asia<\/span> cohort will be presented at an upcoming congress. The combination of amivantamab and lazertinib is approved in the United States<\/span>, Europe<\/span> and the Asia-Pacific<\/span> region in the Japan<\/span>, <\/span>China<\/span>, Australia<\/span>, Korea and Taiwan<\/span> markets for first-line treatment for patients with\u00a0EGFR<\/i>-mutated NSCLC based on the global MARIPOSA Phase 3 study.\u00a0<\/p>\n

About\u00a0amivantamab\u00a0<\/b>\u00a0<\/p>\n

Amivantamab-vmjw, a fully-human bispecific antibody targeting EGFR<\/i> and MET with immune cell-directing activity, is approved in the U.S.,<\/a>\u00a0Europe<\/span><\/a>\u00a0and five countries and markets in\u00a0Asia-Pacific region\u00a0in combination with lazertinib for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR<\/i> exon 19 deletions or exon 21 L858R substitution mutations.<\/p>\n

Amivantamab is approved in the U.S.<\/a>, Europe<\/span><\/a>\u00a0and nine countries and markets in Asia-Pacific<\/span> region\u00a0in combination with chemotherapy (carboplatin-pemetrexed) for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR<\/i> exon 19 deletions or L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR<\/i> TKI.<\/p>\n

Amivantamab\u00a0is approved in the U.S.<\/a>, Europe<\/span><\/a>\u00a0and eleven countries and markets in Asia-Pacific<\/span> region\u00a0in combination with chemotherapy (carboplatin and pemetrexed) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR<\/i> exon 20 insertion mutations. \u00a0<\/p>\n

Amivantamab is approved in the U.S.<\/a>, Europe<\/span><\/a>\u00a0and\u00a0twelve countries and markets in Asia-Pacific<\/span> region as monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR<\/i> exon 20 insertion mutations.\u00a0<\/p>\n

About <\/b>lazertinib<\/b><\/p>\n

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<\/span>). Lazertinib is an oral, third-generation, brain-penetrant EGFR<\/i> TKI that targets both the T790M mutation and activating EGFR<\/i> mutations while sparing wild-type EGFR<\/i>. An analysis of the efficacy and safety of lazertinib from the Phase 3 LASER301 study was published in The Journal of Clinical Oncology<\/a><\/i> in 2023.[8]<\/sup><\/p>\n

About Non-Small Cell Lung Cancer<\/b><\/p>\n

Worldwide, lung cancer is one of the most common cancers, with NSCLC making up 80 to 85 percent of all lung cancer cases.[9]<\/sup>,<\/sup>[10] The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma.[11] <\/sup>Among the most common driver mutations in NSCLC are alterations in EGFR<\/i>, which is a receptor tyrosine kinase controlling cell growth and division.[12]<\/sup> EGFR<\/i> 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.[12],[13],[14],[15],[16] <\/sup>EGFR<\/i> ex19del or EGFR<\/i> L858R mutations are the most common EGFR<\/i> mutations.[17]<\/sup> The five-year survival rate for all people with advanced NSCLC and EGFR<\/i> mutations treated with EGFR<\/i> TKIs is less than 20 percent.[18],[19]<\/sup> EGFR<\/i> exon 20 insertion mutations are the third most prevalent activating EGFR<\/i> mutation.[20]<\/sup> Patients with EGFR<\/i> 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<\/i> ex19del or L858R mutations, who have a real-world five-year OS of 19 percent.[21]<\/sup> 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.[22]<\/sup><\/p>\n

About Johnson & Johnson\u00a0<\/b><\/p>\n

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<\/a> or at http:\/\/www.innovativemedicine.jnj.com\/<\/a>. Follow us at @JNJInnovMed<\/a>. Johnson & Johnson International (Singapore<\/span>) Pte. Ltd is a Johnson & Johnson company.<\/p>\n

Cautions Concerning Forward-Looking Statements\u00a0 <\/i><\/b><\/p>\n

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\u202fJohnson & 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\u202fJohnson & 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<\/a>, http:\/\/www.jnj.com<\/a>, or on request from\u202fJohnson & Johnson. Johnson & Johnson does not\u202fundertake to update any forward-looking statement as a result of new information or future events or developments.\u202f\u202f\u202f\u202f\u202f\u202f<\/i>\u00a0<\/p>\n

*Professor Byoung Chul Cho\u00a0has not been paid for any media work.<\/p>\n

**Mr. Kazuo Hasegawa<\/span> has served as a consultant to J&J; he has not been paid for any media work.<\/p>\n

\u00a7 <\/sup>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.<\/p>\n

\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\n

[1] <\/sup>Zhang YL, Yuan JQ, Wang KF, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget. 2016;7(48):78985-78993. doi:10.18632\/oncotarget.12587<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[2]<\/sup>\u00a0Roeper J, et al. Risk of not receiving 2nd line therapy is high in EGFR mt+ pts: Real world data of certified lung cancer centers on treatment sequence in EGFR mt+ pts. J Clin Oncol. 2018;36(suppl):e21220. doi:10.1200\/JCO.2018.36.15_suppl.e21220<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[3]<\/sup>\u00a0Sabari JK, Yu HA, Mahadevia PJ, et al. Overall survival in EGFR-mutant advanced non\u2013small cell lung cancer treated with first-line osimertinib: a cohort study integrating clinical and biomarker data in the United States. J Thorac Oncol. Published online May 2, 2025. doi:10.1016\/j.jtho.2025.04.010<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[4]<\/sup> ClinicalTrials.gov. A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (MARIPOSA). https:\/\/classic.clinicaltrials.gov\/ct2\/show\/NCT04487080. Accessed September 2025.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[5]<\/sup> Girard, et al. Preventing Moderate to Severe Dermatologic Adverse Events in First-line EGFR-mutant Advanced NSCLC Treated with Amivantamab Plus Lazertinib: Early Success of the COCOON Trial. 2025 European Lung Cancer Congress. March 27, 2025.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[6]<\/sup> Spira AI, et al.\u00a0Preventing infusion-related reactions with intravenous amivantamab\u2014results from SKIPPirr, a phase 2 study: a brief report. J Thorac Oncol<\/i>. 2025;20(6):809-816.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[7]<\/sup> Leighl N, et al.\u00a0Subcutaneous 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. J Clin Oncol<\/i>. 2024;42(30):3593-3605.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[8]<\/sup>\u00a0Cho BC, et al. Lazertinib versus gefitinib as first-line treatment in patients with EGFR-mutated advanced non-small-cell lung cancer: Results From LASER301. J Clin Oncol<\/i>. 2023;41(26):4208-4217.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[9]<\/sup>\u00a0The World Health Organization. Cancer.\u00a0https:\/\/www.who.int\/news-room\/fact-sheets\/detail\/cancer. Accessed\u00a0September 2025.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[10]\u00a0<\/sup>American Cancer Society. What is Lung Cancer? https:\/\/www.cancer.org\/content\/cancer\/en\/cancer\/lung-cancer\/about\/what-is.html. Accessed\u00a0September 2025.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[11]<\/sup> Oxnard JR, et al. Natural history and molecular characteristics of lung cancers harboring EGFR exon 20 insertions. J Thorac Oncol<\/i>. 2013;8(2):179-84. doi: 10.1097\/JTO.0b013e3182779d18.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[12]<\/sup> Bauml JM, et al. Underdiagnosis of EGFR Exon 20 Insertion Mutation Variants: Estimates from NGS-based Real World Datasets. 2021 World Conference on Lung Cancer Annual Meeting; January 29, 2021.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[13]<\/sup>\u00a0Pennell NA, et al. A phase II trial of adjuvant erlotinib in patients with resected epidermal growth factor receptor-mutant non-small cell lung cancer. J Clin Oncol<\/i>. 37:97-104.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[14]<\/sup>\u00a0Burnett H, et al. Epidemiological and clinical burden of EGFR exon 20 insertion in advanced non-small cell lung cancer: a systematic literature review. 2021 World Conference on Lung Cancer Annual Meeting; January 29, 2021.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[15]<\/sup>\u00a0Zhang YL, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget<\/i>. 2016;7(48):78985-78993.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[16]<\/sup>\u00a0Midha A, et al. EGFR mutation incidence in non-small-cell lung cancer of adenocarcinoma histology: a systematic review and global map by ethnicity. Am J Cancer Res<\/i>. 2015;5(9):2892-2911.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[17]<\/sup>\u00a0American Lung Association. EGFR and Lung Cancer.\u00a0https:\/\/www.lung.org\/lung-health-diseases\/lung-disease-lookup\/lung-cancer\/symptoms-diagnosis\/biomarker-testing\/egfr. Accessed\u00a0September 2025.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[18]<\/sup>\u00a0Howlader N, et al. SEER Cancer Statistics Review, 1975-2016, National Cancer Institute.\u00a0Bethesda, MD,\u00a0https:\/\/seer.cancer.gov\/csr\/1975_2016\/, based on\u00a0November 2018\u00a0SEER data submission, posted to the SEER web site.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[19]<\/sup>\u00a0Lin JJ, et al. Five-year survival in EGFR-mutant metastatic lung adenocarcinoma treated with EGFR-TKIs. J Thorac Oncol<\/i>. 2016;11(4):556-65.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[20]\u00a0<\/sup>Arcila, M. et al. EGFR exon 20 insertion mutations in lung adenocarcinomas: prevalence, molecular heterogeneity, and clinicopathologic characteristics.\u00a0Mol Cancer Ther<\/i>. 2013; 12(2):220-9.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[21]<\/sup>\u00a0Girard N, et al. Comparative clinical outcomes for patients with NSCLC harboring EGFR exon 20 insertion mutations and common EGFR mutations. Abstract presented at: World Conference on Lung Cancer Annual Meeting;\u00a0January 29, 2021; Singapore.\u00a0<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[22]<\/sup>\u00a0Surveillance, Epidemiology, and End Results (SEER) Program, National Cancer Institute, 2024.<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n

\u00a0<\/p>\n

<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":[],"rop_publish_now_history":[],"rop_publish_now_status":"pending","footnotes":""},"categories":[5,7],"tags":[],"class_list":["post-32549","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cision-pr-newswire","category-cision-pr-newswire-en"],"_links":{"self":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/32549","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=32549"}],"version-history":[{"count":0,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/32549\/revisions"}],"wp:attachment":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=32549"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=32549"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=32549"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}