Large Cell Carcinoma

Advancements in targeted therapies have transformed the treatment landscape for NSCLC, enabling precision medicine approaches that improve outcomes. These therapies focus on specific genetic mutations or molecular drivers, such as EGFR, ALK, ROS1, BRAF, and MET, which are commonly implicated in NSCLC. Drugs targeting these mutations, such as tyrosine kinase inhibitors (TKIs), offer significant benefits, including higher response rates, improved progression-free survival, and fewer off-target effects compared to traditional chemotherapy. Additionally, continuous innovation has led to the development of next-generation inhibitors that overcome resistance to earlier therapies, further enhancing their efficacy. LAS VEGAS, Jan. 14, 2025 /PRNewswire/ -- DelveInsight's ' Non-Small Cell Lung Cancer Pipeline Insight 2025 ' report provides comprehensive global coverage of pipeline NSCLC therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the NSCLC pipeline domain. Key Takeaways from the Non-Small Cell Lung Cancer Pipeline Report DelveInsight's NSCLC pipeline report depicts a robust space with 100+ active players working to develop 120+ pipeline therapies for NSCLC treatment. Key NSCLC companies such as Merck Sharp & Dohme LLC, AbbVie, Qilu Pharmaceutical Co., Ltd., Suzhou Puhe Pharmaceutical Technology Co., LTD, Exelixis, Genmab, OncoResponse, Inc., Next Point Therapeutics, Inc., Light Chain Bioscience - Novimmune SA, Immunitas Therapeutics, Hansoh BioMedical R&D Company, Mythic Therapeutics, Shanghai Henlius Biotech, and others are evaluating new NSCLC drugs to improve the treatment landscape. Promising NSCLC pipeline therapies such as V940, Telisotuzumab Vedotin, QL1706, YK-029A, XL092, PRO1184, OR2805, NPX267, NI-1801, IMT-009, HS-20117, MYTX-011, HLX301, and others are under different phases of NSCLC clinical trials. In December 2024, the FDA granted breakthrough therapy designation to sacituzumab tirumotecan (MK-2870/SKB264/) for the treatment of patients with advanced or metastatic nonsquamous non–small cell lung cancer (NSCLC). In September 2024, AbbVie announced that it had submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for accelerated approval of elotuzumab vedotin (Teliso-V) in adult patients with previously treated, locally advanced or metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression. In August 2024, the FDA granted Fast track designation to Deltacel (KB-GDT-01) with low-dose radiation therapy to potentially treat patients with metastatic non–small cell lung cancer (NSCLC) whose disease progressed on 2 or more prior lines of standard-of-care therapy, including immune checkpoint inhibitors, platinum-based chemotherapy, and targeted therapy. In July 2024, Nuvalent announced the first patient dosed in HEROEX-1 Phase Ia/Ib clinical trial of NVL-330, its novel HER2-selective Inhibitor. In April 2024, ABVC BioPharma announced that the Company and its affiliate Rgene Corporation entered into a comprehensive licensing agreement with OncoX for the drug ABV-1501. Under the terms of the agreement, ABVC grants OncoX exclusive rights for one of ABVC's four products in its Oncology pipeline to develop, manufacture, and commercialize BLEX 404. In April 2024, Hansoh Pharma announced that the Class 1 new drug " HS-10504 tablet" independently developed by its subsidiary Jiangsu Hansoh Pharmaceutical Group Co., Ltd. and Shanghai Hansoh Biomedical Technology Co., Ltd. had obtained the clinical trial notification letter issued by the National Medical Products Administration of the People's Republic of China. It is intended for the treatment of advanced non-small cell lung cancer, with specific indications to be determined after clinical trials. In February 2024, the FDA granted breakthrough therapy designation to NVL-520 as a treatment for patients with ROS1-positive metastatic non–small cell lung cancer (NSCLC) who received prior treatment with at least 2 ROS1 tyrosine kinase inhibitors (TKIs). Request a sample and discover the recent advances in NSCLC treatment drugs @ Non-Small Cell Lung Cancer Pipeline Report The NSCLC pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage NSCLC drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the NSCLC clinical trial landscape. Non-Small Cell Lung Cancer Overview Non-small cell lung cancer (NSCLC) is the most prevalent form of lung cancer, originating in the tissues of the lungs. Unlike small cell lung cancer, which grows rapidly, NSCLC typically develops more slowly but often spreads to other parts of the body by the time it is diagnosed, emphasizing the need for early detection and treatment. Small-cell lung cancer derives its name from the small, round appearance of its cells under a microscope, while the cells in NSCLC are larger. Despite its slower growth, NSCLC is frequently diagnosed at an advanced stage, further underscoring the importance of early intervention. In the United States, approximately 230,000 people are diagnosed with lung cancer annually, and it accounts for an estimated 135,000 deaths each year. Lung cancer causes more deaths than prostate, breast, brain, and colorectal cancers combined. It is the leading cause of cancer deaths in men and the second most common in women. However, these figures are declining, largely due to anti-smoking initiatives and reduced tobacco use. The classification of lung tumors is based on the 2015 World Health Organization (WHO) guidelines, which utilize immunohistochemistry and light microscopy to guide treatment decisions and predict outcomes. NSCLC encompasses several subtypes, including adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. Adenocarcinoma, the most common subtype, accounts for nearly half of all lung cancer cases. Squamous cell carcinoma, once the most prevalent, typically originates in the tracheobronchial tree but is now more frequently found in peripheral lung areas. Large cell carcinoma is a diagnosis of exclusion, characterized by poor differentiation and lack of specific classification through immunohistochemistry or electron microscopy. The causes of NSCLC can be divided into avoidable and unavoidable risk factors. Tobacco use remains the most significant preventable risk factor, while other causes include alcohol consumption, exposure to secondhand smoke, asbestos, radon, arsenic, chromium, nickel, ionizing radiation, and polycyclic aromatic hydrocarbons. Diagnosis involves a comprehensive blood count (CBC), a complete metabolic panel (CMP), and imaging studies. Hypercalcemia or elevated alkaline phosphatase may indicate metastasis to bones. Initial imaging with a chest X-ray can help identify nonspecific signs, followed by computed tomography (CT) for detailed characterization. A tissue biopsy is essential for confirming the diagnosis through histopathologic and immunohistochemistry evaluation. Treatment options for NSCLC include standard therapies like surgery, radiation, chemotherapy, targeted therapy, and immunotherapy, as well as newer approaches like laser therapy, photodynamic therapy (PDT), and cryosurgery. The choice of treatment depends on the cancer's stage, the patient's functional status, comorbidities, and the molecular characteristics of the tumor. Surgery is often required for localized cases, while advanced stages may call for a combination of therapies. Participation in clinical trials can also offer access to emerging treatments. Managing NSCLC requires a collaborative, interprofessional approach, beginning with prevention. Primary care providers play a critical role in smoking cessation counseling and early detection through lung cancer screening, which can improve prognosis by identifying the disease before it progresses to advanced stages. Find out more about NSCLC treatment drugs @ Drugs for Non-Small Cell Lung Cancer Treatment A snapshot of the Non-Small Cell Lung Cancer Pipeline Drugs mentioned in the report: Learn more about the emerging NSCLC pipeline therapies @ Non-Small Cell Lung Cancer Clinical Trials Non-Small Cell Lung Cancer Therapeutics Assessment The NSCLC pipeline report proffers an integral view of the NSCLC emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Non-Small Cell Lung Cancer Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Therapeutics Assessment By Mechanism of Action: Immunostimulants, Antibody-dependent cell cytotoxicity, Cytotoxic T-lymphocyte antigen 4 inhibitors, Programmed cell death 1 receptor antagonists, T lymphocyte stimulants, Apoptosis stimulants, Mitosis inhibitors, Tubulin inhibitors, Tubulin polymerization inhibitors, Epidermal growth factor receptor antagonists, Proto-oncogene protein c-met inhibitors Key Non-Small Cell Lung Cancer Companies: Merck Sharp & Dohme LLC, AbbVie, Qilu Pharmaceutical Co., Ltd., Suzhou Puhe Pharmaceutical Technology Co., LTD, Exelixis, Genmab, OncoResponse, Inc., Next Point Therapeutics, Inc., Light Chain Bioscience - Novimmune SA, Immunitas Therapeutics, Hansoh BioMedical R&D Company, Mythic Therapeutics, Shanghai Henlius Biotech, and others Key Non-Small Cell Lung Cancer Pipeline Therapies: V940, Telisotuzumab Vedotin, QL1706, YK-029A, XL092, PRO1184, OR2805, NPX267, NI-1801, IMT-009, HS-20117, MYTX-011, HLX301, and others Dive deep into rich insights for new drugs for NSCLC treatment, visit @ Non-Small Cell Lung Cancer Drugs Table of Contents For further information on the NSCLC pipeline therapeutics, reach out @ Non-Small Cell Lung Cancer Treatment Drugs Related Reports Non-Small Cell Lung Cancer Market Non-Small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key NSCLC companies including EMD Serono, Merck, Cellular Biomedicine Group, Inc., Celgene, CellSight Technologies, Inc., BeyondSpring Pharmaceuticals Inc., J Ints Bio, Forward Pharmaceuticals Co., Ltd., AstraZeneca, Bristol-Myers Squibb, Teligene US, Rain Oncology Inc, ReHeva Biosciences, Inc., Amgen, Novartis, RedCloud Bio, Parexel, Vitrac Therapeutics, LLC, Mythic Therapeutics, Instil Bio, Mirati Therapeutics Inc., Daiichi Sankyo, Inc., AstraZeneca, Precision Biologics, Inc, Promontory Therapeutics Inc., Palobiofarma SL, Regeneron Pharmaceuticals, Revolution Medicines, Inc., Cullinan Oncology, LLC, Iovance Biotherapeutics, Inc., Innate Pharma, among others. HER2-mutant Non-Small Cell Lung Cancer Pipeline HER2-mutant Non-Small Cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key HER2-mutant non-small cell lung cancer companies, including Dizal Pharmaceuticals, Puma Biotechnology, AstraZeneca, Jiangsu Hengrui Medicine, among others. Small Cell Lung Cancer Market Small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key advanced small cell lung cancer companies, including Ascentage Pharma, Merck & Co, AstraZeneca, Advenchen Laboratories, Advanced Accelerator Applications, Trillium Therapeutics, Wigen Biomedicine, Linton Pharm, Carrick Therapeutics, among others. Small-cell Lung Cancer Pipeline Small-cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key small-cell lung cancer companies, including Ascentage Pharma, Merck & Co, AstraZeneca, Advenchen Laboratories, GlaxoSmithKline, Advanced Accelerator Applications, Trillium Therapeutics, Vernalis, Oncoceutics, NewBio Therapeutics, Wigen Biomedicine, Linton Pharm, Carrick Therapeutics, Xencor, Jiangsu HengRui Medicine, Aileron Therapeutics, Roche, Ipsen, Celgene, Lee's Pharmaceutical Limited, AbbVie, G1 Therapeutics, Chipscreen Biosciences, Luye Pharma Group, Shanghai Henlius Biotech, CSPC ZhongQi Pharmaceutical Technology, Impact Therapeutics, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Median overall survival improvement expected to exceed one year First and only regimen with a survival benefit over current standard of care in first-line treatment of EGFR-mutated lung cancer RARITAN, N.J., Jan. 7, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced positive topline results for the gold standard endpoint in cancer treatment of overall survival (OS) from the Phase 3 MARIPOSA study, evaluating RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (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) exon 19 deletions (ex19del) or L858R substitution mutations. The chemotherapy-free combination regimen met the final pre-specified secondary endpoint of OS and demonstrated clinically meaningful and statistically significant improvement in OS versus the current standard of care osimertinib. Improvement in median OS is expected to exceed one year. Unlike progression-free survival (PFS), which tracks the time a treatment keeps a patient's cancer from progressing, OS helps patients understand the impact therapy could have on the ability to live longer from the start of treatment. Extending life expectancy is the most meaningful indicator of a treatment's impact. "The combination of these two agents previously demonstrated an improvement in progression-free survival, but this does not always capture the impact on the entire treatment course. Evaluation of overall survival can better demonstrate the benefit of a first-line treatment regimen," said Stephen Liu, M.D.*, Associate Professor of Medicine at Georgetown University School of Medicine and Director of Thoracic Oncology and Head of Developmental Therapeutics at Georgetown's Lombardi Comprehensive Cancer Center. "Seeing this increase in overall survival in a trial with mature data is powerful and reaffirms that first-line treatment with RYBREVANT and LAZCLUZE can lead to better patient outcomes." "Every milestone in clinical trials and every approval of a new drug or regimen brings hope and progress for EGFR-positive patients and their families," said Marcia Horn**, President of International Cancer Advocacy Network. "These topline data from the MARIPOSA trial offer renewed optimism in the journey to extend life for EGFR-mutated patients, adding another important option for patients and oncologists." "These new findings reinforce the clinically meaningful impact this chemotherapy-free regimen can have for patients worldwide with non-small cell lung cancer and represent the first overall survival benefit over the current standard of care," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson Innovative Medicine. "With less than 20 percent of patients living beyond five years, an incredible unmet need remains for EGFR-positive lung cancer. These MARIPOSA results show RYBREVANT plus LAZCLUZE can extend survival beyond the current standard of care, providing patients with more time and hope in their fight against this devastating disease. Extending median overall survival by more than a year could be transformative for these patients." Results from the final OS analysis build upon previously reported data from the interim analysis and positive results from the PFS analysis. MARIPOSA, which enrolled 1,074 patients, is a randomized, Phase 3 study evaluating RYBREVANT® in combination with LAZCLUZE™ versus osimertinib as a first-line treatment of patients with EGFR-mutated NSCLC. The study's primary endpoint was PFS (using RECIST v1.1 guidelines***) 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. The safety profile of RYBREVANT® plus LAZCLUZE™ was generally consistent with the profiles of the individual treatments. Adverse event rates were consistent in this arm as compared to other RYBREVANT® regimens. Venous thromboembolic events were observed with the combination. Subsequent studies showed that administering oral anticoagulant medicines prophylactically during the initial four months of the RYBREVANT® and LAZCLUZE™ regimen significantly reduced the risk of thrombosis. Due to the impact of these data on patient care, these OS results will be presented at an upcoming major medical meeting, and will be shared with global health authorities. RYBREVANT® combined with LAZCLUZE™ is approved in the United States and Europe for the first-line treatment of patients with EGFR-mutated NSCLC based on the MARIPOSA Phase 3 study. About RYBREVANT® RYBREVANT® (amivantamab-vmjw), a fully-human bispecific antibody targeting EGFR and MET with immune cell-directing activity, is approved in the U.S., Europe and other markets around the world as monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.1 RYBREVANT® is approved in the U.S., Europe and other markets around the world 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, as detected by an FDA-approved test. RYBREVANT® is approved in the U.S. and Europe in combination with LAZCLUZE™ (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or L858R substitution mutations, as detected by an FDA-approved test. RYBREVANT® is approved in the U.S., Europe and other markets around the world in combination with chemotherapy (carboplatin and 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 tyrosine kinase inhibitors (TKI). The National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for NSCLC§ prefer next-generation sequencing–based strategies over polymerase chain reaction–based approaches for the detection of EGFR exon 20 insertion variants. The NCCN Guidelines include: Amivantamab-vmjw (RYBREVANT®) plus lazertinib (LAZCLUZE™) as a Category 1 recommendation for first-line therapy in patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations.2†‡ Amivantamab-vmjw (RYBREVANT®) plus chemotherapy as a Category 1 recommendation for patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations who experienced disease progression after treatment with osimertinib.2†‡ Amivantamab-vmjw (RYBREVANT®) plus chemotherapy as a Category 1 recommendation for first-line therapy in treatment-naive patients with newly diagnosed advanced or metastatic EGFR exon 20 insertion mutation-positive advanced NSCLC.2†‡ Amivantamab-vmjw (RYBREVANT®) as a Category 2A recommendation for patients that have progressed on or after platinum-based chemotherapy with or without an immunotherapy and have EGFR exon 20 insertion mutation-positive NSCLC.2†‡ For more information, visit: . About LAZCLUZE ™ In 2018, Janssen Biotech, Inc., entered into a license and collaboration agreement with Yuhan Corporation for the development of LAZCLUZE™ (marketed as LACLAZA in Korea). LAZCLUZE™ 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 LAZCLUZE™ from the Phase 3 LASER301 study was published in The Journal of Clinical Oncology in 2023. 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.3,4 The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma.5 Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase controlling cell growth and division.6 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.5,6,7,8,9,10 EGFR ex19del or EGFR L858R mutations are the most common EGFR mutations.11 The five-year survival rate for all people with advanced NSCLC and EGFR mutations treated with EGFR TKIs is less than 20 percent.12,13 EGFR exon 20 insertion mutations are the third most prevalent activating EGFR mutation.14 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.15 IMPORTANT SAFETY INFORMATION1,16 Before you receive RYBREVANT® as a single agent or in combination, tell your healthcare provider about all of your medical conditions, including if you: have a history of lung or breathing problems. are pregnant or plan to become pregnant. RYBREVANT® and LAZCLUZE™ can harm your unborn baby. Females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start treatment with RYBREVANT® or RYBREVANT® in combination with LAZCLUZE™. You should use effective birth control (contraception) during treatment and for 3 months after your final dose of RYBREVANT®. For patients receiving LAZCLUZE™: You should use effective birth control (contraception) during treatment and for 3 weeks after your last dose of LAZCLUZE™. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with RYBREVANT® or LAZCLUZE™. Males who have female partners who are able to become pregnant: You should use effective birth control during treatment and for 3 weeks after your last dose of LAZCLUZE™. are breastfeeding or plan to breastfeed. It is not known if RYBREVANT® passes into your breast milk. Do not breastfeed during treatment and for 3 months after your last dose of RYBREVANT®. It is not known if LAZCLUZE™ passes into your breast milk. Do not breastfeed during treatment and for 3 weeks after your last dose of LAZCLUZE™. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. LAZCLUZE™ may affect the way other medicines work, and other medicines may affect how LAZCLUZE™ works. You should not start or stop any medicine before you talk with your healthcare provider that prescribed LAZCLUZE™. How will I receive RYBREVANT®? RYBREVANT® will be given to you by your healthcare provider by intravenous infusion into your vein. Your healthcare provider will decide the time between doses as well as how many treatments you will receive. Your healthcare provider will give you medicines before each dose of RYBREVANT® to help reduce the risk of infusion-related reactions. RYBREVANT® may be given in combination with the medicines carboplatin and pemetrexed. If you have any questions about these medicines, ask your healthcare provider. If your treatment with RYBREVANT® is given in combination with LAZCLUZE™ (lazertinib), you should take your dose of LAZCLUZE™ by mouth anytime before your infusion with RYBREVANT®. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. How should I take LAZCLUZE™? Take LAZCLUZE™ exactly as your healthcare provider tells you to take it. Take LAZCLUZE™ one (1) time each day. On the day RYBREVANT® is also given, take LAZCLUZE™ anytime before receiving the RYBREVANT® infusion. You can take LAZCLUZE™ with or without food. Swallow LAZCLUZE™ tablets whole. Do not crush, cut, or chew the tablets. If you miss a dose of LAZCLUZE™ and: it has been less than 12 hours, take the missed dose. it has been more than 12 hours, skip the dose and take your next dose at your regularly scheduled time. If you vomit a dose of LAZCLUZE™, do not take an extra dose. Take your next dose at your regularly scheduled time. LAZCLUZE™ may be given in combination with other anti-cancer medicines. If you have any questions about these medicines, ask your healthcare provider. What should I avoid while receiving RYBREVANT® and/or LAZCLUZE™? RYBREVANT® and RYBREVANT® in combination with LAZCLUZE™ can cause skin reactions. You should limit your time in the sun during and for 2 months after your treatment with RYBREVANT® and/or LAZCLUZE™. Wear protective clothing and use sunscreen during treatment with RYBREVANT® and/or LAZCLUZE™. What are the possible side effects of RYBREVANT® or LAZCLUZE™? RYBREVANT® and LAZCLUZE™ may cause serious side effects, including: infusion-related reactions. Infusion-related reactions are common with RYBREVANT® and can be severe or serious. Tell your healthcare provider right away if you get any of the following symptoms during your infusion of RYBREVANT®: lung problems. RYBREVANT® may cause lung problems that may lead to death. LAZCLUZE™ may also cause lung problems that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away if you get any new or worsening lung symptoms, including shortness of breath, cough, or fever. blood clot problems. Blood clots are a serious, but common side effect of RYBREVANT®, when given together with LAZCLUZE™, may cause blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism) that may lead to death. Your healthcare provider will start you on medicine to prevent blood clots for the first 4 months of treatment. Tell your healthcare provider right away if you have any signs and symptoms of blood clots, including swelling, pain or tenderness in the leg, sudden unexplained chest pain, or shortness of breath. skin problems. RYBREVANT® can cause severe rash; including blisters, peeling, skin pain and sores, redness, raised acne-like bumps, itching, and dry skin. LAZCLUZE™ may cause severe rash including redness, raised acne-like bumps, itching, and dry skin. You may use alcohol-free (isopropanol-free, ethanol-free) moisturizing cream to reduce the risk of skin problems. Tell your healthcare provider right away if you get any skin reactions. Your healthcare provider may treat you with a medicine(s) or send you to see a skin specialist (dermatologist) if you get skin reactions during treatment with RYBREVANT® or LAZCLUZE™. See "What should I avoid while receiving RYBREVANT® and/or LAZCLUZE™?" eye problems. RYBREVANT® may cause eye problems. LAZCLUZE™ may also cause eye problems. Tell your healthcare provider right away if you get symptoms of eye problems which may include: Your healthcare provider may send you to see an eye specialist (ophthalmologist) if you get new or worsening eye problems during treatment with RYBREVANT® or LAZCLUZE™. You should not use contact lenses until your eye symptoms are checked by a healthcare provider. The most common side effects of RYBREVANT® in combination with LAZCLUZE™ (lazertinib) include: The most common side effects of RYBREVANT® when given in combination with carboplatin and pemetrexed include: The most common side effects of RYBREVANT® when given alone: LAZCLUZE™ may cause fertility problems in males and females, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you. Your healthcare provider may temporarily stop, decrease your dose, or completely stop your treatment with RYBREVANT® or LAZCLUZE™ if you have serious side effects. These are not all of the possible side effects of RYBREVANT® or LAZCLUZE™. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. General information about the safe and effective use of RYBREVANT®: Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your healthcare provider or pharmacist for information about RYBREVANT® that is written for health professionals. General information about the safe and effective use of LAZCLUZE™: Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use LAZCLUZE™ for a condition for which it was not prescribed. Do not give LAZCLUZE™ to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about LAZCLUZE™ that is written for health professionals. Please read full Prescribing Information for RYBREVANT®. Please read full Prescribing Information for LAZCLUZE™. 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 or at . Follow us at @JanssenUS and @JNJInnovMed. Janssen Research & Development, LLC, and Janssen Biotech, Inc., are Johnson & Johnson companies. 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) and LAZCLUZE™ (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, Janssen Biotech, Inc. 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 31, 2023, 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. None of Janssen Research & Development, LLC, Janssen Biotech, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. *Dr. Liu has served as a consultant to J&J; he has not been paid for any media work. **Marcia Horn 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. †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. §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. Source: Johnson & Johnson 1 RYBREVANT® Prescribing Information. Horsham, PA: Janssen Biotech, Inc. 2 Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.9.2024 © National Comprehensive Cancer Network, Inc. All rights reserved. To view the most recent and complete version of the guideline, go online to NCCN.org. Accessed December 2024. 3 The World Health Organization. Cancer. . Accessed December 2024. 4 American Cancer Society. What is Lung Cancer? . Accessed December 2024. 5 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. 6 Bauml JM, et al. Underdiagnosis of EGFR Exon 20 Insertion Mutation Variants: Estimates from NGS-based Real World Datasets. Abstract presented at: World Conference on Lung Cancer Annual Meeting; January 29, 2021; Singapore. 7 Pennell 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. 37:97-104. 8 Burnett H, et al. Epidemiological and clinical burden of EGFR exon 20 insertion in advanced non-small cell lung cancer: a systematic literature review. Abstract presented at: World Conference on Lung Cancer Annual Meeting; January 29, 2021; Singapore. 9 Zhang YL, 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. 10 Midha 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. 2015;5(9):2892-2911. 11 American Lung Association. EGFR and Lung Cancer. . Accessed December 2024. 12 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. 13 Lin JJ, et al. Five-year survival in EGFR-mutant metastatic lung adenocarcinoma treated with EGFR-TKIs. J Thorac Oncol. 2016 Apr;11(4):556-65. 14 Arcila, M. et al. EGFR exon 20 insertion mutations in lung adenocarcinomas: prevalence, molecular heterogeneity, and clinicopathologic characteristics. Mol Cancer Ther. 2013 Feb; 12(2):220-9. 15 Girard 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; January 29, 2021; Singapore. 16 LAZCLUZE™ Prescribing Information. Horsham, PA: Janssen Biotech, Inc. 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This multitargeted, chemotherapy-free combination demonstrated superiority over osimertinib monotherapy for the first-line treatment of patients with EGFR-mutated NSCLC 1 In the Phase 3 MARIPOSA study, amivantamab plus lazertinib significantly reduced the risk of disease progression or death by 30 percent versus osimertinib monotherapy 1 BEERSE, Belgium I Decemer 30, 2024 I Janssen-Cilag International NV, a Johnson & Johnson company, today announced that the European Commission (EC) has approved a Type II variation extension of indication for RYBREVANT ® ▼ (amivantamab), in combination with LAZCLUZE ® ▼ (lazertinib), for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or exon 21 L858R substitution mutations. “For people living with advanced NSCLC harbouring EGFR mutations, new treatment options are urgently needed in the first-line setting,” said Enriqueta Felip, M.D., Ph.D, head of the thoracic cancer unit at Vall d’Hebron University Hospital, Barcelona, Spain*. “The amivantamab and lazertinib combination has shown significant progression-free survival improvements in patients with previously untreated EGFR-mutated advanced NSCLC, including those with brain metastases, compared to osimertinib monotherapy. This approval by the European Commission offers the potential to broaden first-line treatment options and provide a new standard of care for eligible patients.” Lung cancer is Europe’s biggest cancer killer, with NSCLC accounting for 85 percent of all lung cancer cases. 2,3 EGFR mutation-positive NSCLC refers to a subtype of lung cancer based on specific mutations in the EGFR gene. 4 While there are different types of EGFR mutations, EGFR ex19del and EGFR exon 21 L858R are the most common, accounting for approximately 85-90 percent of mutations. 4 Patients are often treated with targeted therapies known as EGFR tyrosine kinase inhibitors (TKIs). 5 However, treatment resistance or disease reoccurrence remains a significant challenge and there is an urgent need for alternative, novel targeted therapies earlier in the treatment pathway to address resistance and improve survival outcomes. 6,7 “This approval marks significant progress for those living with the devastating impact of EGFR-mutated non-small cell lung cancer, who too often face a poor prognosis and limited treatment options,” said Henar Hevia, Ph.D., Senior Director, EMEA Therapeutic Area Lead, Oncology. “The combination of amivantamab and lazertinib exemplifies the potential of targeted precision medicine, offering a tailored approach that addresses the underlying genetic drivers of the disease, and avoids or delays the need for chemotherapy.” The EC approval is supported by results from the Phase 3 MARIPOSA ( NCT04487080 ) study, evaluating amivantamab in combination with lazertinib compared to osimertinib as first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR ex19del or exon 21 L858R substitution mutations. 1 The study, which was featured during a Presidential Symposium session at the 2023 European Society of Medical Oncology (ESMO) Congress, met its primary endpoint of progression-free survival (PFS), and at median follow-up of 22 months, amivantamab plus lazertinib reduced the risk of disease progression or death by 30 percent compared to osimertinib (median PFS: 23.7 months versus 16.6 months; hazard ratio [HR]=0.70; 95 percent confidence interval [CI], 0.58–0.85; P <0.001) as assessed by blinded independent central review (BICR). 1 The median duration of response (DOR) was longer for patients receiving amivantamab plus lazertinib compared to osimertinib, with a nine-month improvement in median DOR (25.8 vs. 16.8 months). 1 The safety profile of the combination of amivantamab and lazertinib was consistent with previous reports from Phase 1-2 studies, with mostly Grade 1 or 2 adverse events (AEs). 1 Toxicity was largely manageable with dose interruptions and reductions, along with supportive care measures commonly used in the treatment of patients with NSCLC. 1 The most common treatment emergent adverse events (TEAEs) of any grade were paronychia (68 percent), infusion-related reactions (63 percent), and rash (62 percent). 1 Amivantamab plus lazertinib had higher rates of EGFR- and MET-related AEs and venous thromboembolism compared to osimertinib, except diarrhoea, for which rates were higher for osimertinib. 1 The commonest grade 3 or higher TEAEs were rash (15 percent), paronychia (11 percent) and dermatitis acneiform (8 percent). 1 The rate of discontinuation of all study treatments due to treatment-related AEs for the amivantamab combination was 10 percent. 1 The rate of interstitial lung disease (including pneumonitis) was less than three percent in both arms. 1 An EC decision on a Marketing Authorisation (MA) for lazertinib for the corresponding combination regimen indication is pending, following a Committee for Medicinal Products for Human Use (CHMP) positive opinion last month. 8 – ENDS – Notes to editors About the MARIPOSA Study MARIPOSA ( NCT04487080 ), which enrolled 1,074 patients, is a randomised, Phase 3 study evaluating amivantamab in combination with lazertinib versus osimertinib and versus lazertinib alone in first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR ex19del or exon 21 L858R substitution mutations. 1 The primary endpoint of the study is PFS (using RECIST v1.1 guidelines ‡ ) as assessed by BICR. 1 Secondary endpoints include overall survival (OS), overall response rate (ORR), duration of response (DOR), second progression free survival (PFS2) and intracranial PFS. 1 The MARIPOSA study required all patients to have serial brain imaging with magnetic resonance imaging (MRI), which is important for a disease where almost 30 percent of patients develop brain metastases. 1,9 The primary endpoint of PFS in MARIPOSA included these central nervous system (CNS) events detected by serial brain MRIs. 1 The median PFS when censoring CNS-only first progressions was 27.5 months for the combination of amivantamab and lazertinib, compared to 18.5 months for osimertinib (HR=0.68; 95 percent CI, 0.56–0.83; P <0.001**). 1 Extracranial PFS, which may more closely approximate what would be seen in other trials, was also explored in MARIPOSA. 1 Longer-term follow-up data presented at the International Association for the Study of Lung Cancer (IASLC) 2024 World Conference on Lung Cancer (WCLC) demonstrated a strong favourable overall survival (OS) trend for amivantamab plus lazertinib versus Osimertinib. At three years (median follow-up of 31.1 months), 61 percent of patients receiving amivantamab plus lazertinib were alive compared to 53 percent of those treated with osimertinib based on an analysis performed at the request of a health authority*** (median OS not estimable [NE] vs 37.3 months; HR=0.77; 95 percent CI, 0.61-0.96; nominal P =0.019). 10 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. 11,12,13,14 The European Commission (EC) has granted marketing authorisation of amivantamab in the following indications: 15 In May 2024, an application for the extension of the amivantamab marketing authorisation was submitted seeking approval for the use of a subcutaneous (SC) formulation of amivantamab in combination with lazertinib for the first-line treatment of adult patients with advanced NSCLC with EGFR ex19del or L858R mutations, and for the use of SC amivantamab monotherapy in adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy. 16 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 . 15 ▼ In line with EMA regulations for new medicines, amivantamab is subject to additional monitoring. About Lazertinib In 2018, Janssen Biotech, Inc., entered into a license and collaboration agreement with Yuhan Corporation for the development of 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. 17 An analysis of the efficacy and safety of lazertinib from the Phase 3 study LASER301 was published in The Journal of Clinical Oncology in 2023. 17 ▼ In line with EMA regulations for new medicines, lazertinib 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. 2 NSCLC accounts for 85 percent of all lung cancer cases. 3 Lung cancer is Europe’s biggest cancer killer, with more deaths than breast cancer and prostate cancer combined. 2 The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma and large cell carcinoma. 3 Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase controlling cell growth and division. 3,18 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. 19,20,21,22 EGFR ex19del or EGFR exon 21 L858R mutations are the most common EGFR mutations. 23 The five-year survival rate for 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. 24,25,26 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://innovativemedicine.jnj.com/emea/ . Follow us at http://www.linkedin.com/company/jnj-innovative-medicine-emea . Janssen-Cilag International NV, Janssen Research & Development, LLC, Janssen Biotech, Inc. and Janssen-Cilag, S.A. are Johnson & Johnson companies. * Prof. Felip has served as a consultant to Janssen-Cilag International NV; she has not been paid for any media work. ** Nominal P -value; endpoint was exploratory and not part of hierarchical hypothesis testing. *** This analysis was requested by health authorities and had nominal alpha spend. A P-value of ≤0.00001 was required for statistical significance. ‡ RECIST (version 1.1) refers to Response Evaluation Criteria in Solid Tumors, which is a standard way to measure how well solid tumours respond to treatment and is based on whether tumours shrink, stay the same or get bigger. 1 Cho BC, et al. Amivantamab Plus Lazertinib in Previously Untreated EGFR-Mutated Advanced NSCLC. The New England Journal of Medicine 2024. doi:10.1056/NEJMoa2403614. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa2403614 . Accessed December 2024. 2 Global Cancer Observatory. Cancer Today. Available at: https://gco.iarc.who.int/media/globocan/factsheets/populations/908-europe-fact-sheet.pdf . Accessed December 2024. 3 Zappa C, et al. Non-small cell lung cancer: current treatment and future advances. Transl Lung Cancer Res . 2016;5(3):288–300. 4 Batra U, et al . Differential clinicopathological features, treatments and outcomes in patients with Exon 19 deletion and Exon 21 L858R EGFR mutation-positive adenocarcinoma non-small-cell lung cancer. BMJ Open Respir Res. 2023 Jun;10(1). 5 Johnson M, et al . Treatment strategies and outcomes for patients with EGFR-mutant non-small cell lung cancer resistant to EGFR tyrosine kinase inhibitors: Focus on novel therapies. Lung Cancer. 2022 Aug;170:41-51. 6 Pecci F, et al . Non-small-cell lung cancer: how to manage EGFR-mutated disease. Drugs Context. 2022;11:2022-4-1. 7 Fu, K, et al . Therapeutic strategies for EGFR-mutated non-small cell lung cancer patients with osimertinib resistance. J Hematol Oncol. 15, 173 (2022). https://doi.org/10.1186/s13045-022-01391-4. 8 Innovativemedicine.jnj.com/EMEA. RYBREVANT®▼ (amivantamab) in combination with LAZCLUZE®▼ (lazertinib) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer. Available at: https://innovativemedicine.jnj.com/emea/chmp-recommends-rybrevant-amivantamab-in-combination-with-lazcluze-lazertinib-for-the-first-line-treatment-of-patients-with-egfr-mutated-advanced-non-small-cell-lung-cancer . Accessed December 2024 9 Fuchs J, et al. Resection of isolated brain metastases in non-small cell lung cancer (NSCLC) patients – evaluation of outcome and prognostic factors: A retrospective multicenter study. PLoS ONE. 16(6):e0253601. https://doi.org/10.1371/journal.pone.0253601 . 10 Gadgeel SM, et al. Amivantamab Plus Lazertinib vs Osimertinib in First-line EGFR-mutant Advanced NSCLC: Longer Follow-up of the MARIPOSA Study. IASLC WCLC 2024. September 8, 2024. 11 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. 12 Moores SL, et al. A Novel Bispecific Antibody Targeting EGFR and cMet Is Effective against EGFR Inhibitor-Resistant Lung Tumors. Cancer Res . 2016;76(13)(suppl 27216193):3942-3953. 13 Yun J, 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. 14 Vijayaraghavan S, 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. 15 European Medicines Agency. Amivantamab Summary of Product Characteristics. August 2024. Available at https://www.ema.europa.eu/en/documents/product-information/rybrevant-epar-product-information_en.pdf . Accessed December 2024. 16 Innovativemedicine.jnj.com/EMEA. Johnson & Johnson submits application to the European Medicines Agency seeking approval of subcutaneous formulation of RYBREVANT ® ▼ (amivantamab) for the treatment of patients with EGFR-mutated non-small cell lung cancer. Available at: https://innovativemedicine.jnj.com/emea/newsroom/oncology/johnson-johnson-submits-application-to-the-european-medicines-agency-seeking-approval-of-subcutaneous-formulation-of-rybrevant-amivantamab-for-the-treatment-of-patients-with-egfr-mutated-non-small-cell-lung-cancer . Accessed December 2024. 17 Cho, 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 . 2023;41(26):4208-4217. 18 Wee P & Wang Z. Epidermal Growth Factor Receptor Cell Proliferation Signaling Pathways. Cancers . 2017;9(12):52. 19 Pennell 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 . 2019;37(2):97-104. 20 Burnett H, et al. Epidemiological and clinical burden of EGFR exon 20 insertion in advanced non-small cell lung cancer: a systematic literature review. Abstract presented at: World Conference on Lung Cancer Annual Meeting (Singapore); January 29, 2021. 21 Zhang YL, 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. 22 Midha 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 . 2015;5(9):2892-2911. 23 American Lung Association. EGFR and Lung Cancer. Available at: https://www.lung.org/lung-health-diseases/lung-disease-lookup/lung-cancer/symptomsdiagnosis/biomarker-testing/egfr . Accessed December 2024. 24 Lin JJ, et al. Five-Year Survival in EGFR-Mutant Metastatic Lung Adenocarcinoma Treated with EGFR-TKIs. J Thorac Oncol . 2016;11(4):556-65. 25 Nieva J, et al. A real-world (rw) observational study of long-term survival (LTS) and treatment patterns after first-line (1L) osimertinib in patients (pts) with epidermal growth factor receptor (EGFR) mutation-positive (m) advanced non-small cell lung cancer (NSCLC). Ann Oncol . 2023;34, S774. 26 Girard N, et al. Mortality among EGFR-mutated advanced NSCLC patients after frontline osimertinib treatment: A real-world, US attrition analysis. J Thorac Oncol. 2023;18(4), S51-52. SOURCE: Janssen