An Open-label, Multicenter Phase Ib/II Study to Evaluate the Safety, Efficacy and Pharmacokinetic Characteristics of ANS014004 in Combination With EGFR-TKI in Patients With EGFR Mutation-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Protocol Title
A Study to Evaluate ANS014004 in Combination with EGFR-TKI in Patients with EGFR Mutation-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
The main purpose of this research study is to
Find a safe and tolerable dose of two investigational drugs, ANS014004 and PLB1004, when used together.
Learn how effective this drug combination is at treating a type of lung cancer called "EGFR mutation-positive non-small cell lung cancer (NSCLC)" that has spread to other parts of the body (locally advanced or metastatic).
This study is trying to answer the following questions:
Safety & Dosing: What are the side effects of combining ANS014004 and PLB1004? What is the best dose to use that patients can tolerate well?
Effectiveness: Can this combination of drugs help shrink patients' tumors or stop them from growing?
Background Information
For patients with advanced lung cancer that has a specific gene change called an "EGFR mutation," targeted therapies known as EGFR-TKIs are a standard treatment. While these treatments often work well at first, most tumors eventually stop responding to the drug (this is called "acquired resistance"). The investigational drug ANS014004 is designed to block a protein called MET, which is one of the ways that tumors become resistant to EGFR-TKIs. The researchers believe that by combining ANS014004 with the EGFR-TKI PLB1004, they may be able to prevent or delay resistance, offering patients a more effective and longer-lasting treatment option.
How will the study be conducted?
This study is divided into two parts:
Part 1 (Dose Escalation and Optimization): A small number of participants will receive different dose levels of ANS014004 combined with a fixed dose of PLB1004. The goal is to find the safest and most tolerable dose combination.
Part 2 (Phase II Study): Once a recommended dose is identified, more participants will be enrolled to further evaluate how well the drug combination works against the cancer.
Throughout the study, participants' health will be closely monitored, and their tumors will be measured regularly using imaging scans (like CT scans) to see how they respond to the treatment.

Start Date01 Jun 2026

Sponsor / Collaborator

Beijing Purunao Biotechnology Co Ltd

[+1]

NCT07336732

/ RecruitingPhase 2

An Open-label, Randomized, Multicenter Phase II/III Study to Evaluate the Efficacy and Safety of Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Harboring Atypical EGFR Mutations Who Have Not Received Prior Systematic Therapy

This study is an open-label, randomized, multicenter phase II/III clinical trial designed to evaluate the efficacy, safety, and tolerability of Andamertinib with or without platinum-based chemothsrapy versus platinum-based chemotherapy in previously untreated participants with locally advanced or metastatic non-squamous NSCLC harboring EGFR atypical mutations. The study comprises two stages: phase II (dose-exploration stage) and phase III (pivotal study stage)

Start Date11 Mar 2026

Sponsor / Collaborator

Avistone Biotechnology Co., Ltd.

ChiCTR2600117889

/ Not yet recruitingPhase 2IIT

A clinical trial of Vebreltinib plus Andamertinib in NSCLC with MET overexpression following EGFR-TKI

Start Date01 Oct 2025

Sponsor / Collaborator

Zhongshan Hospital Fudan University

100 Clinical Results associated with Andamertinib

100 Translational Medicine associated with Andamertinib

100 Patents (Medical) associated with Andamertinib

Literatures (Medical) associated with Andamertinib

01 Mar 2026·Journal of Thoracic Oncology

Andamertinib in Advanced NSCLC With EGFR Exon 20 Insertions After Platinum-Based Chemotherapy or Immunotherapy: Results From the Phase 2 KANNON Study

Article

Author: Fu, Zhen-Ming ; Xue, Wei-Zhe ; Yang, Run-Xiang ; Yao, Yu ; Wang, Chang-Li ; Wang, Ping ; Min, Xu-Hong ; Li, Xiao-Ling ; Duan, Jian-Chun ; Mu, Yu ; Zheng, Yi ; Zhang, Pei-Long ; Wang, Zhe-Hai ; Lv, Dong-Qing ; Han, Di ; Xu, Rui-Lian ; Zhao, Jun ; Zhao, Yan-Qiu ; Shi, He-Peng ; Sun, Long-Hua ; Yang, Jin-Ji ; Zhou, Jian-Ya ; Wu, Lin ; Xu, Hai-Peng ; Ma, Hui-Wen ; Zhong, Hua ; Wu, Yi-Long ; Shen, Bo ; Zhang, Yan

OBJECTIVES:

This study aimed to evaluate andamertinib, a selective and irreversible tyrosine kinase inhibitor, in pretreated advanced EGFR exon 20 insertion (ex20ins)-mutant NSCLC.

METHODS:

In the phase 2, multicenter, single-arm KANNON study (NCT06015503), patients with locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations who had progressed after platinum-based chemotherapy or immunotherapy received oral andamertinib 240 mg once daily in 28-day cycles. The primary end point was the confirmed objective response rate (ORR) assessed by independent review.

RESULTS:

A total of 92 patients were enrolled and received daily 240 mg andamertinib, with nearly 30 different exon20ins subtypes included. The confirmed ORR was 42.7% (95% confidence interval [CI], 32.4-53.0), with a disease control rate of 86.5% and a median duration of response of 8.7 months (95% CI, 5.65-11.96). As of September 6, 2025, with a median follow-up of 15.4 (range, 0.4-20.5) months, the median progression-free survival was 6.2 months (95% CI, 4.63-7.85) and median overall survival was not reached (95% CI, 13.93 mo to not estimable), with a 12-month survival rate of 70.5%. Among 38 patients with brain metastasis, the systemic confirmed ORR was 47.4% (95% CI, 31.5-63.2). Grade more than or equal to 3 treatment-related adverse events occurred in 40.2% of patients, and the most frequent events were diarrhea (12.0%) and rash (7.6%). No interstitial lung disease or grade more than or equal to 3 QT prolongation was reported.

CONCLUSIONS:

Andamertinib at 240 mg once daily demonstrated efficacy with a manageable safety profile in previously treated patients with EGFR ex20ins-mutant NSCLC.

01 Dec 2025·CANCER CHEMOTHERAPY AND PHARMACOLOGY

Pharmacokinetics, mass balance, and metabolism of [14C]PLB1004, a selective and irreversible EGFR-TKI in humans

Article

Author: Geng, Fei ; Yan, Shu ; Zhao, Furong ; Zhang, Peilong ; Wang, Feiyu ; Xue, Weizhe ; Gao, Lei ; Ye, Panpan ; Liu, Donghui ; Li, Weiqiang ; Diao, Xingxing ; Zhao, Wei ; Li, Qian ; Zhang, Xinyue ; Zhou, Haiyan

PURPOSE:

PLB1004, developed by Beijing Avistone Biotechnology Co., Ltd., is a safe, highly selective, and efficient irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) employed in treating non-small-cell-lung-cancer (NSCLC). This study investigated its pharmacokinetics, mass balance, and metabolism in 6 healthy Chinese male subjects treated with 160 mg (70 µCi) [¹⁴C]PLB1004.

METHODS:

Following drug administration, samples of blood, urine and feces were collected for quantitative determination of total radioactivity and metabolites were identified through radioactivity detection coupled with UHPLC-MS/MS.

RESULTS:

Following drug administration, the median radioactive T_max was 4.17 h in plasma, with the average t_1/2 of PLB1004-related components in plasma of approximately 54.3 h. Over 264 h post-administration, the average cumulative excretion among the six subjects was 95.01% of the administered dose, with 84.71% and 10.30% excreted in feces and urine, respectively. Nine metabolites were characterized and identified and the parent drug PLB1004 was detected in plasma, urine, and feces. Among these metabolites, M689 was the most prevalent one in plasma, urine, and feces, constituting 25.37% of the total plasma radioactivity, and 55.88% and 1.73% of the administrated dose in feces and urine, respectively.

CONCLUSION:

Fecal excretion emerged as PLB1004 excretion route, while urinary excretion via the kidneys served as the secondary route. The primarily metabolic pathways are oxidation, demethylation, dehydrogenation, and cysteine conjugation in humans.

News (Medical) associated with Andamertinib

01 Jun 2025

·pipelinereview.com

Avistone Announces Encouraging Results for Vebreltinib plus Andamertinib (PLB1004) in EGFR-mutated NSCLC with MET Amplification or Overexpression at ASCO Annual Meeting 2025

BEIJING, China I May 31, 2025 I Beijing Avistone Biotechnology Co., Ltd (“Avistone”), an innovative biotechnology company focused on precision oncology therapeutics, today announced that the clinical data for Vebreltinib plus Andamertinib (PLB1004), its innovative combination of potent mesenchymal-epithelial transition factor (MET) inhibitor and epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), has been presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025. The details of the poster presentation are provided below: Poster title: Vebreltinib plus Andamertinib (PLB1004) in EGFR-mutated NSCLC with MET Amplification or Overexpression after failure on EGFR-TKIs treatment: phase Ib/II KYLIN-1 study Abstract Number For Publication: 8632 Session: Poster Session-Lung Cancer- Non-Small Cell Metastatic Location: Poster Board, 112 Session Date/Time: 5/31/2025 1:30pm-4:30pm CDT MET amplification or overexpression is the most common “off-target” mechanism that drives resistance to EGFR-TKIs in NSCLC patients. The results from Phase Ib/II KYLIN-1 study (NCT06343064) showed that Vebreltinib plus Andamertinib demonstrated notable efficacy and manageable safety in EGFR-mutated NSCLC patients with MET amplification or overexpression after EGFR-TKIs failure. Among the 56 patients enrolled at a dose of Vebreltinib 150mg BID plus Andamertinib 80mg QD (RP2D), the confirmed overall response rate (ORR) was 50.0%, and the median progression-free survival (mPFS) was 9.9 months. In 19 patients with brain metastases, ORR was 42.1% and mPFS was 9.5 months. Grade 3 or higher treatment related adverse events (TRAEs) occurred in 19.6% of the patients. None discontinued treatment or died due to TRAEs. No new safety signal was observed. A multicenter Phase III study, KYLIN-3 study (NCT06970782), is currently ongoing to further evaluate Vebreltinib plus Andamertinib versus platinum-based doublet chemotherapy in patients with EGFR mutations, MET amplification and/or overexpression, locally advanced or metastatic NSCLC following EGFR-TKI failure. To obtain a copy of the poster, please email Avistone. About Vebreltinib Vebreltinib is an orally, potent and selective c-Met inhibitor. Chinese National Medical Products Administration (NMPA) has formally approved the use of Vebreltinib in locally advanced or metastatic NSCLC patients with MET exon 14 skipping mutations, as well as adult patients with isocitrate dehydrogenase mutant astrocytoma with the PTPRZ1-MET fusion gene or glioblastoma with a history of low-grade disease who have the PTPRZ1-MET fusion gene and have failed previous treatments. Currently, Chinese Center for Drug Evaluation (CDE) has formally accepted its New Drug Application (NDA) and granted it priority review, intended for patients with locally advanced or metastatic NSCLC with MET amplification. About Andamertinib (PLB1004) Andamertinib (PLB1004) is an oral, potent, irreversible, and selective EGFR-TKI with potent blood-brain barrier penetration and broad tyrosine kinase activity. Preclinical studies have shown that it can effectively and irreversibly target exon 20 insertion. Additionally, it can also potently target classical EGFR mutations, such as Del19, L858R and T790M with a high degree of selectivity. About Avistone Biotechnology Beijing Avistone Biotechnology Co., Ltd. (“Avistone”) is an innovative biotechnology company dedicated to precision therapies with significant unmet medical needs for patients worldwide. Avistone maintains an extensive pipeline of targeted therapies in Non-Small Cell Lung Cancer (NSCLC) and other solid tumors. SOURCE: Avistone Biotechnology

Phase 3Clinical ResultPriority ReviewASCOPhase 1

11 Mar 2025

·www.prnewswire.com

TAGRISSO Sets the Stage for Market Leadership in Oncology with Strong Growth Prospects | DelveInsight

TAGRISSO has become a standard treatment due to its strong efficacy in both first-line and adjuvant settings. The growing prevalence of EGFR mutations, a rise in lung cancer diagnoses, and broader approvals for early-stage treatment all contribute to its promising growth potential. LAS VEGAS , March 11, 2025 /PRNewswire/ -- DelveInsight's " TAGRISSO Market Size, Forecast, and Market Insight Report" highlights the details around TAGRISSO, a kinase inhibitor of the EGFR, which binds irreversibly to certain mutant forms of EGFR (T790M, L858R, and exon 19 deletions) at approximately nine-fold lower concentrations than wild-type. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of TAGRISSO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. AstraZeneca's TAGRISSO (osimertinib) Overview TAGRISSO is a prescription medication for adults with non-small cell lung cancer (NSCLC) that carries specific EGFR gene mutations. It is used to help prevent cancer recurrence after surgical tumor removal, as a first-line treatment for metastatic NSCLC, or for patients whose cancer has spread and no longer responds to prior EGFR TKI therapy. As a kinase inhibitor, TAGRISSO irreversibly targets specific mutant forms of EGFR (T790M, L858R, and exon 19 deletions) with significantly higher selectivity than the wild-type EGFR. After oral administration, two active metabolites (AZ7550 and AZ5104) circulate at around 10% of the parent drug and exhibit similar inhibitory effects as osimertinib. In vitro studies also show that osimertinib inhibits HER2, HER3, HER4, ACK1, and BLK at clinically relevant levels. The recommended TAGRISSO dosage is 80 mg once daily, taken with or without food, and continued until disease progression or unacceptable toxicity occurs. Learn more about TAGRISSO projected market size for EGFR mNSCLC @ TAGRISSO Market Potential EGFR is a protein that plays a crucial role in cell growth. When mutations occur in the EGFR gene, they can lead to excessive cell growth, potentially causing cancer. These mutations can take various forms, including deletions, insertions, and point mutations. Among the most common EGFR mutations detected in test results are the EGFR exon 19 deletion and the EGFR L858R point mutation. In non-small cell lung cancer, targeted therapies primarily focus on EGFR-sensitizing mutations and EGFR exon 20 insertions. The most frequently observed EGFR mutations include exon 19 deletions and exon 21 L858R mutations. To address these, the FDA has approved several tyrosine kinase inhibitors (TKIs). In 2023, the EGFR-mutated NSCLC market across the 7MM was valued at approximately USD 4 billion. The NSCLC treatment landscape is becoming increasingly biomarker-driven, with EGFR emerging as one of the most lucrative targets. TAGRISSO remains the leading therapy in this segment, maintaining a strong market presence. However, resistance to EGFR TKIs, particularly after TAGRISSO treatment, is a growing challenge. Developing treatments for patients who experience resistance remains one of the most pressing unmet needs in this space. Discover more about the EGFR mNSCLC market in detail @ EGFR Metastatic Non-small Cell Lung Cancer Market Report Emerging Competitors of TAGRISSO The promising candidates in EGFR NSCLC pipeline include Patritumab deruxtecan (Daiichi Sankyo/AstraZeneca), Zipalertinib (Cullinan Oncology/Taiho Pharma), Aumolertinib/Almonertinib/HS-10206 (Jiangsu Hansoh Pharmaceutical), Savolitinib (AstraZeneca/Hutchison MediPharma), Ivonescimab (AK112/SMT112) (Akeso Biopharma/Summit Therapeutics), Firmonertinib (ArriVent BioPharma), Sunvozertinib (DZD9008) (Dizal Pharmaceutical), BNT327/PM8002 (Biotheus/BioNTech), Zanidatamab (Jazz Pharmaceuticals), TAS3351 (Taiho Oncology), H002 (RedCloud Bio), JIN-A02 (J INTS BIO), FWD1509 (Forward Pharma), Sasanlimab (Pfizer), Pamvatamig (MCLA-129) (Merus), REQORSA (quaratusugene ozeplasmid) (Genprex), PT-112 (Promontory Therapeutics), HMBD-001 (Hummingbird Bioscience), PLB1004 (Avistone Biotechnology), Carotuximab (ENV-105) (Kairos Pharma), and others. To know more about the number of competing drugs in development, visit @ TAGRISSO Market Positioning Compared to Other Drugs Key Milestones of TAGRISSO In December 2024, TAGRISSO was approved in Europe for patients with unresectable EGFR-mutated lung cancer based on the results of the LAURA Phase III study. In September 2024, TAGRISSO was approved in the US for patients with unresectable stage III EGFR-mutated lung cancer based on LAURA Phase III trial results. In July 2024, TAGRISSO in combination with pemetrexed and platinum-based chemotherapy, was approved in Europe for the first-line treatment of adult patients with advanced EGFR-mutated NSCLC whose tumors have exon 19 deletions or exon 21 (L858R) mutations. Approval was based on the results from the Phase III FLAURA2 study. In June 2024, TAGRISSO in combination with chemotherapy was approved in Japan as a first-line treatment for patients with EGFR-mutated advanced lung cancer based on Phase III FLAURA2 results. In June 2024, TAGRISSO was granted priority review in the US for patients with unresectable, Stage III EGFR-mutated lung cancer. TAGRISSO was also recently granted BTD by the FDA in this setting. In February 2024, TAGRISSO in combination with chemotherapy was approved in the US for patients with EGFR-mutated advanced lung cancer based on Phase III FLAURA2 results. In October 2023, TAGRISSO plus chemotherapy was granted priority review in the US for patients with EGFR-mutated advanced lung cancer based on FLAURA2 Phase III trial results. In August 2022, TAGRISSO was approved in Japan for adjuvant treatment of patients with early-stage EGFR-mutated lung cancer based on the positive results from the global ADAURA Phase III trial. In May 2021, TAGRISSO was approved in Europe for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer based on unprecedented results from the ADAURA Phase III trial. In December 2020, TAGRISSO was approved in the US for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer based on unprecedented results from the ADAURA Phase III trial. In October 2020, TAGRISSO granted priority review in the US for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer based on the data from the ADAURA Phase III trial. In July 2020, TAGRISSO was granted BTD in the US for the adjuvant treatment of patients with Stage IB–IIIA EGFR-mutated lung cancer based on unprecedented results from the Phase III ADAURA trial. In August 2018, the MHLW approved TAGRISSO for the first-line treatment of patients with inoperable or recurrent EGFR mutation-positive NSCLC In June 2018, the EC granted marketing authorization for TAGRISSO as monotherapy for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations. In April 2018, the US FDA approved TAGRISSO for the first-line treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. In April 2018, Molecular Partners and AstraZeneca announced a clinical collaboration for MP0250 in EGFR-mutated NSCLC with osimertinib. Under the collaboration, AstraZeneca will supply osimertinib for the clinical study. In April 2017, the EC granted full marketing authorization for TAGRISSO for treating adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. In March 2017, the US FDA granted full approval for TAGRISSO for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after an EGFR TKI therapy. TAGRISSO was granted accelerated approval for this indication in November 2015 based on tumor response rate and duration of response. In 2017, TAGRISSO was granted BTD and priority review by the US FDA for the first-line treatment of patients with metastatic NSCLC. In March 2016, the MHLW approved TAGRISSO for the treatment of patients with EGFR T790M mutation-positive inoperable or recurrent NSCLC that is resistant to EGFR-TKI. In January 2016, AstraZeneca and Incyte Corporation announced a clinical trial collaboration to evaluate the efficacy and safety of INCB39110 in combination with osimertinib. In September 2014, the US FDA granted ODD to TAGRISSO for treating EGFR mutation-positive NSCLC. In April 2014, TAGRISSO received BTD from the US FDA for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after an EGFR TKI therapy. In November 2013, TAGRISSO was granted FTD for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after an EGFR TKI therapy. Discover how TAGRISSO is shaping the EGFR NSCLC treatment landscape @ TAGRISSO NSCLC TAGRISSO Market Dynamics TAGRISSO, developed by AstraZeneca, is a third-generation EGFR TKI that has become a key player in the treatment of NSCLC with EGFR mutations. Since its approval, TAGRISSO has gained significant traction due to its efficacy in treating both first-line and post-resistance settings, particularly in patients with the T790M resistance mutation. The drug's ability to penetrate the blood-brain barrier and show strong efficacy against brain metastases has further strengthened its market positioning, leading to widespread adoption among oncologists. A major driver of TAGRISSO's market dynamics is its dominance as the preferred first-line treatment for EGFR-mutated NSCLC. This shift from earlier-generation TKIs has been supported by clinical data demonstrating superior progression-free survival (PFS) and overall survival (OS) benefits. The expansion of TAGRISSO's indications, including its approval in the adjuvant setting for early-stage EGFR-mutated NSCLC, has further broadened its market reach. Additionally, AstraZeneca has aggressively pursued global regulatory approvals, ensuring market access across multiple geographies, particularly in high-prevalence regions such as East Asia, where EGFR mutations are more common. However, TAGRISSO faces growing challenges, including the emergence of resistance mechanisms such as MET amplification and C797S mutations, which limit long-term efficacy. To counteract this, AstraZeneca is exploring combination strategies with MET inhibitors and other targeted therapies. Furthermore, increasing competition from next-generation EGFR TKIs, such as those under development by companies like Takeda and Johnson & Johnson, poses a potential threat. Pricing and reimbursement pressures, particularly in cost-sensitive markets, also impact its commercial strategy, necessitating a balance between pricing optimization and maintaining accessibility. Despite these challenges, TAGRISSO remains a blockbuster drug with robust revenue growth, driven by strong clinical performance and strategic lifecycle management. Ongoing clinical trials evaluating its use in earlier disease stages and in combination therapies could further extend its market leadership. With its strong foothold in the EGFR-mutated NSCLC landscape, TAGRISSO is expected to remain a key driver of AstraZeneca's oncology portfolio in the foreseeable future. Dive deeper to get more insight into TAGRISSO's strengths & weaknesses relative to competitors @ TAGRISSO Market Drug Report Table of Contents Related Reports EGFR Non-small Cell Lung Cancer Market EGFR 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, as well as the market trends, market drivers, market barriers, and key EGFR NSCLC companies, including AstraZeneca, Boehringer Ingelheim, Genentech/Roche, Eli Lilly, Hansoh Pharmaceutical, J&J Innovative Medicine, Pfizer, Cullinan Oncology, Taiho Pharmaceutical, ArriVent Biopharma, Black Diamond Therapeutics, Daiichi Sankyo, Black Diamond Therapeutic, J INTS BIO, NALO Therapeutics, Scorpion Therapeutics, ORIC Pharmaceuticals, among others. EGFR Non-small Cell Lung Cancer Pipeline EGFR 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 EGFR non-small cell lung cancer companies, including Cullinan Oncology, Betta Pharmaceuticals, G1 Therapeutics, Janux Therapeutics, Daiichi Sankyo Company, Suzhou Puhe Pharmaceutical Technology, Genor Biopharma, J Ints Bio, Avistone Pharmaceuticals, Mythic Therapeutics, among others. 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, as well as the market trends, market drivers, market barriers, and key NSCLC companies including Daiichi Sankyo, AstraZeneca, Gilead Sciences, BieGene, AbbVie, Roche, Merck, Novartis, Pfizer, Takeda Pharmaceuticals, Eli Lilly, BerGenBio, GlaxoSmithKline, Duality biologics, among others. Non-small Cell Lung Cancer Pipeline 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 non-small cell lung cancer companies, including BridgeBio Pharma, Daiichi Sankyo, EMD Serono, Merck, BridgeBio Pharma, Abbvie, Pfizer, Eli Lilly and Company BioNTech SE, Shenzhen TargetRx, Taiho Pharmaceutical, Chong Kun Dang, Bristol Myers Squibb, Innovent Biologics, Xuanzhu Biopharmaceutical, Bayer, GeneScience Pharmaceuticals, InventisBio, Apollomics, Imugene, Ono Pharmaceutical, Pierre Fabre, Jiangsu Hengrui Medicine Co., Bristol-Myers Squibb, Surface Oncology, Inhibrx, Sinocelltech, Mirati Therapeutics, REVOLUTION Medicines, Yong Shun Technology Development, Iovance Biotherapeutics, Galecto Biotech, 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

Drug ApprovalPhase 3Priority ReviewAccelerated ApprovalASCO

06 Mar 2025

·www.prnewswire.com

TEPMETKO Continues to Strengthens its Position as a Leading METex14 Skipping NSCLC Therapy | DelveInsight

With increasing biomarker-driven cancer treatments, TEPMETKO benefits from growing adoption in precision oncology. Competition from other MET inhibitors like TABRECTA (capmatinib) exists, but TEPMETKO's once-daily dosing and efficacy profile offer differentiation. LAS VEGAS, March 6, 2025 /PRNewswire/ -- DelveInsight's " TEPMETKO Market Size, Forecast, and Market Insight Report" highlights the details around TEPMETKO, a kinase inhibitor indicated for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of TEPMETKO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. EMD Serono's TEPMETKO (tepotinib) Overview TEPMETKO is a kinase inhibitor prescribed for adult patients with metastatic non-small cell lung cancer (NSCLC) carrying MET exon 14 skipping alterations. The active component is Tepotinib (as hydrochloride monohydrate), administered orally. Patients should be cautioned about the heightened risk of severe or fatal interstitial lung disease/pneumonitis, liver toxicity, and potential embryo-fetal toxicity, necessitating effective contraception during and shortly after treatment. Tepotinib specifically targets MET, including variants with exon 14 skipping mutations. It blocks HGF-dependent and independent MET phosphorylation, disrupting MET-driven signaling pathways. Additionally, at clinically relevant concentrations, Tepotinib inhibits melatonin 2 and imidazoline 1 receptors. In vitro studies show that it suppresses tumor cell proliferation, anchorage-independent growth, and migration of MET-dependent cancer cells. In mouse models with MET-driven tumors, including those with MET exon 14 skipping alterations, Tepotinib reduced tumor growth, sustained MET phosphorylation inhibition, and, in one case, decreased metastasis formation. The recommended dose of TEPMETKO is 450 mg taken orally once daily until disease progression or intolerable toxicity occurs. Patients should take it at the same time each day, swallowing tablets whole without chewing, crushing, or splitting them. If a dose is missed and less than eight hours remain until the next scheduled dose, patients should skip it. In cases of vomiting after taking TEPMETKO, the next dose should be taken at the usual time. Learn more about TEPMETKO projected market size for NSCLC @ TEPMETKO Market Potential Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 81% of all diagnosed cases. Early detection greatly improves outcomes, but diagnosing NSCLC and other lung cancers is challenging because their symptoms are often mistaken for common illnesses or the long-term effects of smoking. Consequently, 80% of NSCLC cases are already at advanced stages by the time they are identified, making treatment more difficult. Around 80% of EGFR mutations in NSCLC involve either exon 19 deletions or the exon 21 L858R substitution, both of which are classified as sensitizing mutations. Until the last decade, chemotherapy was the primary treatment for advanced and metastatic lung cancer. However, this changed in 2015 with the approval of the first immune checkpoint inhibitor (ICI), KEYTRUDA (pembrolizumab), as a second-line therapy for advanced cases. This was followed by TECENTRIQ (atezolizumab) in 2016. Both therapies were later approved for first-line treatment, broadening their use to a larger patient population. In 2020, the combination of OPDIVO (nivolumab) and ipilimumab also received approval as a first-line treatment for metastatic NSCLC. According to DelveInsight, the NSCLC market size across the 7MM is projected to grow from USD 30 billion in 2024, with a substantial CAGR through 2034. This growth is largely driven by the introduction of emerging therapies during the forecast period (2025–2034). Discover more about the NSCLC market in detail @ Non-small Cell Lung Cancer Market Report Emerging Competitors of TEPMETKO The NSCLC pipeline is very robust with the promising therapies such as Telisotuzumab vedotin (AbbVie), Patritumab deruxtecan (Daiichi Sankyo/AstraZeneca), Datopotamab deruxtecan (Daiichi Sankyo/AstraZeneca), Eftilagimod alpha (Immutep), BNT311/GEN1046 (acasunlimab) (Genmab), V940 (mRNA-4157) + Pembrolizumab (Moderna Therapeutics/Merck), Plinabulin + Docetaxel (BeyondSpring), Olomorasib (LY3537982) (Eli Lilly and Company), Zipalertinib (Cullinan Oncology/Taiho Pharma), Ceralasertib (AZD6738) (AstraZeneca), TEDOPI (EP-2101; IDM 2101; OSE-2101) (OSE Immuno-therapeutics), Sigvotatug vedotin (PF08046047) (Pfizer), ANKTIVA (N-803) (ImmunityBio), Aumolertinib/Almonertinib/HS-10206 (Jiangsu Hansoh Pharmaceutical), Niraparib (GSK), Savolitinib (AstraZeneca/Hutchison MediPharma), TRODELVY (Gilead Sciences), Pyrotinib (Jiangsu HengRui Medicine), Ociperlimab (BGB-A1217) (BieGene), Volrustomig (AstraZeneca), Gotistobart (BNT316/ONC-392) (OncoC4/BioNTech), Ivonescimab (AK112/SMT112) (Akeso Biopharma/Summit Therapeutics), ZYNYZ (retifanlimab/INCMGA00012) (Incyte/Macrogenics), Divarasib (GDC-6036) (Roche/Genentech), Tiragolumab (RG6058) (Roche), Sacituzumab Tirumotecan (Merck and Kelun-Biotech), JEMPERLI (dostarlimab/TSR-042) (GSK and AnaptysBio), Zongertinib (BI-1810631) (Boehringer Ingelheim), BAY 2927088 (Bayer), Serplulimab (HLX10) (Shanghai Henlius Biotech), Rilvegostomig (AZD2936) (AstraZeneca), MK-1084 (Merck, Taiho Pharmaceutical, and Astex), Domvanalimab (Arcus Biosciences and Gilead Sciences), OPDUALAG (nivolumab and relatlimab) (Bristol-Myers Squibb), Belrestotug + JEMPERLI (iTeos Therapeutics and GSK), Firmonertinib (ArriVent BioPharma), Sunvozertinib (DZD9008) (Dizal Pharmaceutical), Cobolimab (GSK), Livmoniplimab (AbbVie), Fianlimab (REGN3767) (Regeneron Pharmaceuticals), BNT327/PM8002 (Biotheus/BioNTech), HS-20117 (Hansoh BioMedical), IO102-IO103 + Pembrolizumab (IO Biotech), Naptumomab estafenatox (NeoTX Therapeutics/Active Biotech), FF-10832 (FUJIFILM Corporation), BNT116 (BioNTechSE/Regeneron Pharmaceuticals), CAN-2409 (Candel Therapeutics), Mecbotamab Vedotin (BA3011/CAB-AXL-ADC) (BioAtla), Bemcentinib (BGB 324/BGB-3234/R-428) (BerGenBio/Rigel Pharmaceuticals), DOVBLERON (taletrectinib/AB-106/IBI-344) (Nuvation Bio/Innovent Biologics/Daiichi Sankyo/Nippon Kayaku), Lifileucel (Iovance Biotherapeutics), IBI363 (Innovent Biologics), Sotevtamab (AB-16B5) (Alethia Biotherapeutics), Avutometinib (VS6766) (Verastem Oncology), Vebreltinib (APL-101) (Apollomics), LP-300 (Lantern Pharma), JNJ-90301900 (Johnson & Johnson Innovative Medicine), AMG 193 (Amgen), Luveltamab tazevibulin (Sutro Biopharma), PRT3789 (Prelude Therapeutics), Disitamab vedotin (Seagen), PADCEV (enfortumab vedotin) (Astellas Pharma), RP1 (Replimune), TIVDAK (tisotumab vedotin) (Seagen), Zanidatamab (Jazz Pharmaceuticals), Utidelone injectable (UTD1) (Beijing Biostar Pharmaceuticals), REGN5093-M114 (Regeneron Pharmaceuticals), SLC-391 (SignalChem Lifesciences), fulzerasib (GenFleet), Davutamig (REGN5093) (Regeneron Pharmaceuticals), TAS3351 (Taiho Oncology), H002 (RedCloud Bio), JIN-A02 (J INTS BIO), FWD1509 (Forward Pharma), Sabestomig (AZD7789) (AstraZeneca), Sasanlimab (Pfizer), Selvigaltin (GB1211) (Galecto Biotech), Vepafestinib Helsinn (Healthcare/Taiho Pharmaceutical), EP0031 (A400/ KL590586) (Ellipses Pharma/Kelun-Biotech), Pamvatamig (MCLA-129) (Merus), Zidesamtinib (NVL-520) (Nuvalent), NVL-655 (Nuvalent), RMC-4630 (Revolution Medicines), REQORSA (quaratusugene ozeplasmid) (Genprex), PDC*lung01 (PDC*line Pharma), Evalstotug (BA3071) (BioAtla and BeiGene), PT-112 (Promontory Therapeutics), MRT-2359 (Monte Rosa Therapeutics), GAIA-102 (GAIA BioMedicine), Rigosertib (Traws Pharma), HMBD-001 (Hummingbird Bioscience), PLB1004 (Avistone Biotechnology), ANS03 (Avistone Biotechnology), MYTX-011 (Mythic Therapeutics), A166 (Sichuan Kelun-Biotech Bio-pharmaceutical), Atamparib (BN-2397) (Ribon Therapeutics), DELTACEL (KB-GDT-01) (Kiromic BioPharma), Carotuximab (ENV-105) (Kairos Pharma), YL202 (MediLink Therapeutics), and others. To know more about the number of competing drugs in development, visit @ TEPMETKO Market Positioning Compared to Other Drugs Key Milestones of TEPMETKO In February 2024, the FDA granted traditional approval to TEPMETKO for adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. In February 2022, the EC approved TEPMETKO as monotherapy for the treatment of adult patients with advanced NSCLC harboring alterations leading to METex14 skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. In February 2021, Merck announced that the US FDA has approved TEPMETKO following priority review for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. This indication was approved under accelerated approval based on ORR and DOR. In October 2020, TEPMETKO received ODD for treating NSCLC with MET genomic tumor aberrations In March 2020, EMD Serono (the biopharmaceutical business of Merck KGaA), announced that the MHLW approved TEPMETKO for the treatment of patients with unresectable, advanced, or recurrent NSCLC with METex14 skipping alterations. In September 2019, the US FDA granted BTD for tepotinib in patients with metastatic NSCLC harboring METex14 skipping alterations who progressed following platinum-based cancer therapy Discover how TEPMETKO is shaping the NSCLC treatment landscape @ TEPMETKO NSCLC TEPMETKO Market Dynamics TEPMETKO competes in a growing but highly specialized market where MET-targeted therapies are gaining traction due to their efficacy in addressing MET-altered tumors. The market for MET inhibitors is expanding as precision oncology advances and molecular diagnostics become more widely available, enabling better identification of patients who would benefit from targeted treatments like TEPMETKO. A key factor shaping TEPMETKO's market dynamics is competition. It directly competes with Novartis' TABRECTA (capmatinib), another MET inhibitor approved for the same indication. While TEPMETKO offers the advantage of once-daily dosing compared to TABRECTA's twice-daily regimen, both drugs have similar efficacy profiles, making physician and patient preference an important differentiator. Additionally, broader competition from next-generation MET inhibitors and combination therapies in clinical trials could impact TEPMETKO's long-term market position. Regulatory approvals and market access play a crucial role in TEPMETKO's adoption. The drug has been approved in multiple regions, including the U.S., Europe, and Japan, but reimbursement and pricing strategies vary by market. Payer policies, along with the cost-benefit analysis of MET inhibitors compared to other targeted therapies, influence prescription trends. Furthermore, real-world evidence and post-marketing studies will be critical in demonstrating TEPMETKO's sustained effectiveness and safety, which could support expanded indications and increased market penetration. Looking ahead, the MET inhibitor market is expected to grow with advances in biomarker-driven therapy, further refining patient selection. TEPMETKO's success will depend on continued clinical development, potential label expansions, and strategic partnerships to strengthen its competitive edge. As new entrants emerge, Merck KGaA's ability to differentiate TEPMETKO through combination strategies or enhanced formulations may determine its long-term sustainability in this evolving landscape. Dive deeper to get more insight into TEPMETKO's strengths & weaknesses relative to competitors @ TEPMETKO Market Drug Report Table of Contents 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, as well as the market trends, market drivers, market barriers, and key NSCLC companies including Daiichi Sankyo, AstraZeneca, Gilead Sciences, BieGene, AbbVie, Roche, Merck, Novartis, Pfizer, Takeda Pharmaceuticals, Eli Lilly, BerGenBio, GlaxoSmithKline, Duality biologics, among others. Non-small Cell Lung Cancer Pipeline 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 non-small cell lung cancer companies, including BridgeBio Pharma, Daiichi Sankyo, EMD Serono, Merck, BridgeBio Pharma, Abbvie, Pfizer, Eli Lilly and Company BioNTech SE, Shenzhen TargetRx, Taiho Pharmaceutical, Chong Kun Dang, Bristol Myers Squibb, Innovent Biologics, Xuanzhu Biopharmaceutical, Bayer, GeneScience Pharmaceuticals, InventisBio, Apollomics, Imugene, Ono Pharmaceutical, Pierre Fabre, Jiangsu Hengrui Medicine Co., Bristol-Myers Squibb, Surface Oncology, Inhibrx, Sinocelltech, Mirati Therapeutics, REVOLUTION Medicines, Yong Shun Technology Development, Iovance Biotherapeutics, Galecto Biotech, among others. C-MET Metastatic Non-small Cell Lung Cancer Market C-MET Metastatic 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, as well as the market trends, market drivers, market barriers, and key C-MET mNSCLC companies, including Novartis, Merck, EMD Serono, AbbVie, Regeneron Pharmaceuticals, Mythic Therapeutics, Apollomics, Johnson & Johnson Innovation, Haihe Biopharma, among others. C-MET Non-small Cell Lung Cancer Pipeline C-MET 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 C-MET non-small cell lung cancer companies, including AbbVie, Janssen Research & Development, Beijing Pearl Biotechnology Limited Liability Company, Novartis, 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

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Indication	Country/Location	Organization	Date
EGFR ex20ins mutation in non-small cell lung cancer	China	Avistone (Ningbo) Biotechnology Co., Ltd.	29 Apr 2026

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
EGFR mutation MET positive Non-small Cell Lung Cancer	Phase 3	China	Avistone Biotechnology Co., Ltd.	07 May 2025
Non-squamous non-small cell lung cancer	Phase 3	China	Avistone Biotechnology Co., Ltd.	22 Mar 2024
c-met mutant solid tumour	Phase 2	United States	Avistone Biotechnology Co., Ltd.	01 Jun 2026
Metastatic Lung Cancer	Phase 2	United States	Avistone Biotechnology Co., Ltd.	01 Jun 2026
EGFR positive Non-squamous non-small cell lung cancer	Phase 2	China	Avistone Biotechnology Co., Ltd.	03 Mar 2026
EGFR positive non-small cell lung cancer	Phase 2	China	Avistone (Ningbo) Biotechnology Co., Ltd.	11 Aug 2025
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma	Phase 2	China	Avistone (Ningbo) Biotechnology Co., Ltd.	08 Aug 2025
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 2	China	-	02 Jul 2024
EGFR-mutated non-small Cell Lung Cancer	Phase 2	China	Avistone Biotechnology Co., Ltd.	13 Jun 2023
c-Met positive non-small cell lung cancer	Phase 2	China	Avistone Biotechnology Co., Ltd.	05 Jun 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06015503 (KANNON, Pubmed \| J Thorac Oncol)	Phase 2	EGFR-mutated non-small Cell Lung Cancer EGFR ex20ins mutations	92	Andamertinib 240 mg	nnkztqzwrq(qasjkaxgtj) = cfvhcqrkux xiafvezemm (kwyedyqdmn, 32.4 - 53.0) View more	Positive	01 Mar 2026
				Andamertinib 240 mg (brain metastasis)	nnkztqzwrq(qasjkaxgtj) = grnveeixad xiafvezemm (kwyedyqdmn, 31.5 - 63.2)
NCT06015503 (KANNON, J Thorac Oncol) Manual	Phase 2	EGFR-mutated non-small Cell Lung Cancer EGFR ex20ins mutations	92	Andamertinib 240 mg	yezvuqcgqu(jjuqdphedx) = tgggshtewn nvaywcqwbz (qhcrqztplv, 32.4 - 53.0) View more	Positive	15 Nov 2025
NCT06015503 (KANNON, ESMO2025)	Phase 2	Advanced Lung Non-Small Cell Carcinoma exon 20 insertion mutations	92	PLB-1004 240 mg	cnmfctpekc(sjlncauwlx) = xjwkwdtwry pmmwbavjog (hlyslmloxq, 32.4 - 53.0) View more	Positive	17 Oct 2025
				PLB-1004 240 mg (brain metastasis)	cnmfctpekc(sjlncauwlx) = hopnowjbpz pmmwbavjog (hlyslmloxq, 31.5 - 63.2)
NCT06343064 (WCLC2024) Manual	Phase 1/2	EGFR mutation MET positive Non-small Cell Lung Cancer MET Overexpression \| MET Amplification \| EGFR Mutation	44	Vebreltinib 100mg plus PLB1004 160mg	rvomspdpmg(xixwcwjucs) = aazplqyjck kyceqghhnf (hmggspuxyq )	Positive	10 Sep 2024
				Vebreltinib 150mg plus PLB1004 160mg	rvomspdpmg(xixwcwjucs) = jbcwrymxvr kyceqghhnf (hmggspuxyq )
AACR2023 Manual	Phase 1	Non-Small Cell Lung Cancer Second line EGFR Exon 20 Missense	-	PLB-1004	vuajursrcj(stgrjnoonk) = eengdwoyud wislmapfqb (lgwdcyxqpk )	Positive	14 Apr 2023
				PLB-1004 (EGFR Ex20ins mutations)	niqgxfhlnd(gavzflnezc) = egdtycelpe sbwesdpsky (fzdvznmrcw ) View more

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