RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (Australia), Fast Track (Japan), Special Review Project (China)

Structure/Sequence

Molecular FormulaC29H31ClN6O3

InChIKeyKZVOMLRKFJUTLK-UHFFFAOYSA-N

CAS Registry1946826-82-9

Clinical Trials associated with Tepotinib Hydrochloride Hydrate

NCT06908993

/ Not yet recruitingPhase 3IIT

A Randomized Controlled Trial of Tepotinib vs Standard Treatment in Patients With Advanced MET Exon 14 Mutated Non-Small Cell Lung Cancer

We hypothesize that tepotinib is more effective than the investigator's choice of treatment in patients with MET-mutated NSCLC who have progressed after at least one first-line treatment.
The main benefit concerns patient access to tepotinib. There is currently no access to a new-generation MET TKI in France for METex14 patients, due to lack of comparative data. There are no phase III RCTs underway anywhere in the world. This study is the only opportunity, perhaps the last, to generate comparative data which, if positive, will enable the drug to be reimbursed. With this in mind, the methodology of this study was discussed with the HAS on several occasions beforehand, to ensure that it met their expectations. With a response rate of around 50% and a median progression-free survival of 11 months in previously-treated subjects based on clinical trials data, tepotinib is a key drug for METex14 NSCLC patients, who are generally elderly and frail, and for whom therapeutic options are limited.
We expect to observe a benefit for patients treated with tepotinib compared to the control arm in terms of PFS, quality of life, objective response rate and duration of response. The overall survival benefit may be compromised by allowing patients in the control arm to cross over to tepotinib once they have progressed. However, we have decided to maintain this crossover and consequently use PFS as the primary endpoint, as there is no clinical equipoise regarding the efficacy of tepotinib in METex14 NSCLC patients. The EMA has already approved tepotinib based on efficacy and safety data from clinical trials, and patients and investigators already consider this treatment as an important therapeutic option. Indeed, both ESMO and ASCO guidelines recommend the use of MET TKIs in these patients. In France, although neither tepotinib nor capmatinib are available, crizotinib, a multi-target TKI also active on MET, can be used off-label. If cross-over to tepotinib was not allowed in this trial, most patients would still benefit from cross-over to a MET TKI by receiving off-label crizotinib, which would in any case lead to a misinterpretation of the OS data. Therefore, we believe it is preferable to control for cross-over and expose progressive patients in the control arm to tepotinib and use PFS as the primary endpoint.
Toxicity of MET TKIs is considered as manageable. In the VISION trial, of 313 patients treated with tepotinib (median age: 72 years), 109 (34.8%) experienced grade ≥3 treatment-related adverse events, leading to discontinuation in 46 patients (14.7%). Rates of adverse events (AE) were broadly consistent irrespective of prior therapies. Edema, the most common adverse event of clinical interest (AECI), was reported in 67.1% (grade ≥ 3, 11.2%). Median time to first edema onset was 7.9 weeks (range: 0.1-58.3). Edema was manageable with supportive measures, dose reduction (18.8%), and/or treatment interruption (23.1%), and rarely prompted discontinuation (4.3%). Other AECIs were also manageable and predominantly mild/moderate: hypoalbuminemia, 23.6% (grade ≥ 3, 3.5%); creatinine increase, 22.0% (grade ≥ 3, 1.0%); nausea, 23.3% (grade ≥ 3, 0.6%), diarrhea, 22.4% (grade ≥ 3, 0.3%), decreased appetite (grade ≥ 3, 0.3%), and ALT increase, 14.1% (grade ≥ 3, 2.2%). GI AEs typically occurred early and resolved in the first weeks10,13.
Given the efficacy of tepotinib, the manageable safety profile, and the oral administration of tepotinib, we anticipate that treatment with tepotinib will be associated with improved quality of life.
Treatments offered in the control group correspond to standard treatments for advanced NSCLC in second line or beyond. In terms of prior lines of treatment, the eligibility criteria of the trial are aligned with the EMA label of tepotinib: "indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to MET gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy". We have not included platinum-based chemotherapy as a treatment option in the control arm, considering that patients who are eligible to platinum-based chemotherapy should have received this regimen in first-line, as per ESMO guidelines14. Given the low efficacy of immunotherapy in patients with oncogene addiction, it is unlikely that some patients would receive immunotherapy alone as first-line treatment. Thus, the absence of platinum-based chemotherapy as a treatment choice in the control arm seems reasonable and will reduce the heterogeneity of this arm.

Start Date15 Jul 2025

Sponsor / Collaborator

Intergroupe Francophone Cancerologie Thoracique

CTR20251352

/ RecruitingNot Applicable

盐酸特泊替尼片人体生物等效性试验

[Translation] Bioequivalence study of tepotinib hydrochloride tablets in humans

以南京正大天晴制药有限公司研制的盐酸特泊替尼片（规格：225 mg）为受试制剂（T），Merck (Schweiz) AG持证，Merck Healthcare KGaA生产的盐酸特泊替尼片（商品名：拓得康®，规格：225 mg）为参比制剂（R），研究受试制剂和参比制剂在空腹/餐后状态下单剂量给药时的药代动力学参数，进行人体生物等效性评价。评估南京正大天晴制药有限公司研制的盐酸特泊替尼片的安全性。

[Translation]

Tepotinib hydrochloride tablets (specification: 225 mg) developed by Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd. were used as the test preparation (T), and tepotinib hydrochloride tablets (trade name: Tuodekang®, specification: 225 mg) certified by Merck (Schweiz) AG and produced by Merck Healthcare KGaA were used as the reference preparation (R). The pharmacokinetic parameters of the test preparation and the reference preparation when administered in a single dose in the fasting/postprandial state were studied, and the human bioequivalence evaluation was performed. The safety of tepotinib hydrochloride tablets developed by Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd. was evaluated.

Start Date09 May 2025

Sponsor / Collaborator

Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.

NCT06031688

/ RecruitingPhase 2IIT

A Randomized Phase II Study of Tepotinib With or Without Ramucirumab in Participants With MET Exon 14 Skipping Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP SUB-STUDY)

This phase II Expanded Lung-MAP treatment trial tests tepotinib with or without ramucirumab for the treatment of patients with advanced non-small cell lung cancer that has spread from where it first started (primary site) to other places in the body (stage IV) or that has come back after a period of improvement (recurrent). Tepotinib is used in patients whose cancer has a mutated (changed) form of a gene called MET. It is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal MET protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving tepotinib with ramucirumab may lower the chance of the cancer from growing or spreading in patients with stage IV or recurrent non-small cell lung cancer.

Start Date08 Aug 2024

Sponsor / Collaborator

Eli Lilly & Co.

[+2]

100 Clinical Results associated with Tepotinib Hydrochloride Hydrate

100 Translational Medicine associated with Tepotinib Hydrochloride Hydrate

100 Patents (Medical) associated with Tepotinib Hydrochloride Hydrate

307

Literatures (Medical) associated with Tepotinib Hydrochloride Hydrate

01 Jul 2025·ANTICANCER RESEARCH

Fucoidan Treatment Leads to Attenuated Growth Factor Signaling and Reduced Proliferation in Neuroblastoma Cells

Article

Author: Kaehler, Meike ; Waetzig, Vicki ; Cascorbi, Ingolf ; Alban, Susanne ; Pommert, Nina Sophie ; Weber, Niklas

BACKGROUND/AIM:

Brown algae-derived sulfated polysaccharides, termed as fucoidans, are pharmacologically active substances with pleiotropic anticancer properties, but without known toxicity. In neuroblastoma, an aggressive malignancy with a heterogeneous biological basis, multimodal therapeutic approaches are mandatory for high-risk patients, but these are associated with a problematic safety profile. The present study aimed to examine fucoidan-mediated effects in human neuroblastoma cells to assess their putative tumor-suppressive potential.

MATERIALS AND METHODS:

In Kelly or SH-SY5Y cells, viability was quantified using cell fitness assays. Expression was analyzed using quantitative PCR and the regulation or phosphorylation of proteins using enzyme-linked immunoabsorbent assays (ELISA) or Western blots.

RESULTS:

In Kelly and SH-SY5Y cells, treatment with fucoidans from Fucus vesiculosus (F.v.) or Saccharina latissima (S.l.) for 3 days did not induce cell death, but significantly reduced proliferation (p<0.001), which was associated with attenuated signaling of hepatocyte growth factor (HGF), insulin-like growth factor 2 (IGF2) and vascular endothelial growth factor (VEGF). Despite cell type- and fucoidan-specific differences, co-administration of the fucoidans from F.v. or S.l. and specific receptor inhibitors of HGF (tepotinib), IGF2 (linsitinib) or VEGF (cediranib), distinctly reduced cell viability compared to inhibitor treatment alone in both cell lines (p<0.001). Interestingly, the fucoidan from S.l. also enhanced the antitumor effect of the endothelial growth factor (EGF) receptor inhibitor erlotinib in Kelly and SH-SY5Y cells, although endogenous EGF was not detectable.

CONCLUSION:

Fucoidan treatment decreased proliferation in neuroblastoma cells by interfering with the signal transduction of HGF, IGF2, and VEGF, which substantially increased cellular susceptibility to specific growth factor receptor inhibitors.

01 Jul 2025·CLINICAL CANCER RESEARCH

Liquid and Tissue Biopsies for Identifying MET Exon 14 Skipping NSCLC: Analyses from the Phase II VISION Study of Tepotinib

Article

Author: Rolfo, Christian ; Bruns, Rolf ; Stroh, Christopher ; Johne, Andreas ; Juraeva, Dilafruz ; Paik, Paul K. ; Menzel, Christoph ; O’Brate, Aurora

Abstract:

Purpose::

The VISION trial of tepotinib, a selective MET inhibitor, enrolled patients with non–small cell lung cancer and prospectively detected MET exon 14 (METex14) skipping in liquid biopsies (LBx) and/or tissue biopsies (TBx). We evaluated patient characteristics and outcomes according to METex14 positivity in LBx (LBx-positive) or TBx (TBx-positive).

Experimental Design::

METex14 was centrally assessed by next-generation sequencing of ctDNA from LBx (Guardant360/ArcherMET) and/or RNA from TBx (Oncomine Focus/ArcherMET) or, in Japan only, local TBx PCR. Parallel LBx/TBx testing was recommended but not mandatory. Eligibility required LBx-positive or TBx-positive status. ctDNA burden was analyzed in patients with baseline Guardant360 data.

Results::

METex14 was detected in 469 of 7,937 prescreened/screened patients, 313 of whom were enrolled (TBx-positive, n = 208; LBx-positive, n = 178). LBx-positive patients had higher radiographic tumor burden than TBx-positive patients, including higher median sum of target lesion diameters per RECIST v1.1 (67.1 vs. 55.2 mm) and more patients with ≥3 target lesions (27.5% vs. 18.8%). In 180 TBx-positive patients with matching LBx results, objective response rates were slightly higher in TBx-positive/LBx-positive patients, but TBx-positive/LBx-negative patients had longer duration of response, progression-free survival, and overall survival. In ctDNA analysis (n = 165), detectable baseline ctDNA burden was associated with shorter progression-free survival and overall survival.

Conclusions::

Tepotinib had robust, durable activity in TBx-positive/LBx-negative and TBx-positive/LBx-positive patients. Although LBx is a complementary method to TBx for detecting METex14, it may preferentially select patients with higher tumor burden and poorer prognosis. Undetectable METex14 in baseline ctDNA (due to low ctDNA shedding) may define more favorable treatment outcomes.

01 Jul 2025·INTERNAL MEDICINE

Kidney Injury in Patient with Non-small-cell Lung Cancer Receiving Tepotinib

Article

Author: Mitani, Reo ; Oda, Naohiro ; Takata, Ichiro ; Tokura, Takehiko ; Onishi, Akifumi

We herein report a 68-year-old man with advanced non-small-cell lung cancer treated with tepotinib who showed marked general edema, hypoalbuminemia, and an elevated serum creatinine level. Although tepotinib-induced kidney injury due to creatinine transporter inhibition has been reported, renal biopsy findings suggested tubulointerstitial injury due to decreased renal blood flow, likely secondary to refractory fluid retention. This case highlights the potential for true kidney injury during tepotinib therapy and underscores the importance of careful monitoring and management of adverse renal effects.

News (Medical) associated with Tepotinib Hydrochloride Hydrate

31 Mar 2025

·www.echemi.com

Merck and Roche Join Forces for Tepotinib Commercialization in China

On March 26, 2025, Merck and Roche Pharmaceuticals officially announced a strategic partnership aimed at accelerating the commercialization of Tepotinib (brand name: Togetican®) in the mainland Chinese market. Industry analysts suggest that Merck is leveraging Roche's distribution network in China to expedite the launch of this groundbreaking drug. Tepotinib is the world's first approved MET inhibitor, developed by Merck in Germany. It is an oral, highly selective MET tyrosine kinase inhibitor designed to block cancer signaling pathways caused by MET gene mutations. The drug received approval in Japan in March 2020 for treating patients with unresectable, advanced, or recurrent non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations. In February 2021, Tepotinib gained accelerated approval from the FDA for treating adult patients with metastatic NSCLC who also have these mutations. In December 2023, the drug was officially approved for use in mainland China, targeting locally advanced or metastatic NSCLC patients with MET exon 14 skipping mutations. It was included in the national health insurance catalog by the end of 2024, with implementation starting January 1, 2025. Clinical trials have validated Tepotinib's efficacy, demonstrating its high selectivity and good tolerability, particularly in Asian populations. The drug has received endorsements from prestigious guidelines like NCCN and CSCO. Currently, several MET inhibitors have received global approval, including: Capmatinib (developed by Novartis), which was approved by the FDA in May 2020 as the first targeted therapy for MET exon 14 skipping mutations in NSCLC. In clinical trials, it showed an objective response rate (ORR) of 67.9% in treatment-naive patients. Savolitinib (developed by Hutchison China MediTech), the only MET inhibitor approved in China, also demonstrated encouraging efficacy in patients with MET exon 14 skipping mutations. However, Tepotinib will face competition from domestic MET inhibitors such as Gumetinib from Allergan, which is currently in late-stage clinical trials and could enter the market at a lower price point. Lung cancer remains a leading cause of morbidity and mortality globally, with non-small cell lung cancer (NSCLC) accounting for approximately 85%-90% of cases. The incidence of MET exon 14 skipping mutations in NSCLC patients is about 1%-4%, which, while relatively rare, translates to a significant number of patients given the large patient population and limited treatment options. This partnership is pivotal for Roche, enabling it to expand its footprint in lung cancer treatment. By incorporating Tepotinib into its portfolio, Roche enhances its competitive edge in the precision treatment market for lung cancer, moving beyond its existing focus on ALK and NTRK/ROS1 mutations. Merck's expertise in drug development and innovation combined with Roche's rich experience in commercialization will likely bolster Tepotinib's market competitiveness, promising substantial commercial value for both companies. The success of this collaboration could set a new benchmark in the treatment of lung cancer.

Drug Approval

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

Drug ApprovalImmunotherapyPriority Review

04 Feb 2025

·pharma.economictimes.indiatimes.com

Can Custom Duty exemptions alleviate the high-price burden for cancer patients?

New Delhi: With more than 1.5 million active cases across the country, the prevalence of cancer in India has certainly outpaced the available treatment interventions. However, what makes the situation even worse is the sky-high cost of treatment, which makes these therapies inaccessible to many patients, leaving them in a desperate struggle to secure financial aid and loans for life-saving medicines. A walk around Mumbai’s Tata Memorial Hospital, India’s premium cancer care institution, shows the appalling situation. T he entrance is always overflowing with patients from across the country, while many managing to live in makeshift shelters in extreme financial distress to cope with costs of treatment. A study showed a small fraction of Indians, roughly 3 per cent can afford expensive immunotherapies in India, making it a big challenge for public health establishments to reach modern medicines to the low income strata. To confront this growing crisis, the government has opted for a strategy of waiving customs duties on life-saving medications, thereby reducing import costs and hoping to translate these savings into more affordable treatment options for patients. The Finance Minister said in her Budget 2025 speech, “To provide relief to patients, particularly those suffering from cancer, rare diseases, and other severe chronic conditions, I propose to add 36 life-saving drugs and medicines to the list of medicines fully exempted from Basic Customs Duty .” She also proposed to add “six life-saving medicines to the list attracting a concessional customs duty of 5 percent.” The government order states, “In exercise of the powers conferred by sub-section (1) of section 25 of the Customs Act, 1962 (52 of 1962), the Central Government, on being satisfied that it is necessary in the public interest to do so,” has exempted Basic Customs Duty on 36 life-saving medications. A rough analysis of the list shows that out of the 36 medications, 25 are indicated for the treatment of various types of cancer. Feb 4, World Cancer Day , is the perfect time to assess whether exempting customs duties could make a significant difference to patient expenses. The majority of these drugs are protected by patents, granting them global exclusivity, and are marketed by major pharmaceutical giants such as Merck, Roche, GSK, and AstraZeneca. Strikingly, in the previous Budget 2024, the government announced the exemption of customs duty on three cancer drugs—Osimertinib, Durvalumab, and Trastuzumab Deruxtecan. The first two medications are indicated for lung cancer, while the latter is used in the treatment of breast cancer. All three are marketed by UK pharma giant AstraZeneca. According to the government, “Drugs/medicines generally attract a basic customs duty of 10 percent, while some categories of life-saving drugs/vaccines attract a concessional rate of 5 percent or nil.” The Basic Customs Duty (BCD) is calculated over the customs value, which is the accumulation of the CIF cost where C represents the cost of goods, I stands for insurance, and F accounts for freight or logistics costs. Besides BCD, the government levies a social welfare surcharge of 10 per cent, calculated over the BCD value, and a 5 per cent Integrated Goods and Services Tax (IGST), calculated over the accumulated figure of CIF value and BCD of the imported goods. Speaking to ET Pharma, Leena Menghaney, a lawyer and public health activist, stressed, “The customs duty waiver on some of the exorbitantly priced cancer and rare disease drugs is a welcome move, but it is like a band-aid and does not address the underlying problem of high prices due to patent monopolies that block local production.” “India is a country where half the population lives on less than $1 per day and bears a large public health burden for cancers. How can patients pay for patented medicines like Keytruda ?” she added. While industry stakeholders are still analysing the net impact of the announcement, Dr.B. S. Ajaikumar, Executive Chairman of Healthcare Global Enterprises Limited, said, “The exemption of customs duty will have an impact of 5-10 percent on the price of drugs, and this development will primarily benefit cash-paying patients, with some benefit extending to those utilizing insurance.” Bhanu Prakash Kalmath, a consultant at Grant Thornton Bharat LLP, underlined, “The final reduction will depend on manufacturers, hospitals, and supply chains. This move directly reduces import costs and supports broader access to essential treatments. It also benefits insurance providers, government health schemes like Ayushman Bharat , and Patient Assistance Programs (PAPs).” Under the Patient Assistance Programs (PAP) offered by pharmaceutical companies, medicines are provided in 1+1 or 2+1 packages, where the patient pays for one or two drugs and receives an additional one free of cost. However, under the condition of anonymity, an expert shared that very few patients in the country are currently covered under PAP programs. Additionally, at times, the last-stage providers (mostly hospitals) that stock these drugs apply a profit margin over the products. Furthermore, it is crucial to note that while the Finance Minister’s announcement has exempted customs duties, patients still have to contend with the Maximum Retail Price (MRP) of drugs. The MRP is compiled based on several other costs, as post-import, the product often requires special storage, handling, and packaging before distribution to retail outlets. The distribution costs include transportation to wholesalers and retail outlets, along with the distributor’s margin. To make novel treatments truly affordable for the Indian demographic, Menghaney emphasised, “The country needs to boost local production and competition by granting a compulsory license clause. This would cut the cost of the drug by allowing another company to manufacture the therapy, even though it is still under patent.” “In the past, such measures have slashed prices by introducing local generic versions of cancer drugs—by an astounding 97 percent,” she added. The high price of cancer drugs has long been a contentious issue across low- and middle-income countries (LMICs), including India. However, given the scale and severity of the problem, it categorically requires a more holistic solution—one that ensures benefits are truly materialized for patients. As philanthropist Bill Gates once said, “The good news is that we have the tools to prevent most diseases. But the bad news is that not enough people are getting them.” List of Cancer Drugs to exempted from BCD under Budget 2025-26 S. No. Drug Company Brand Name MRP (INR) 1. Pembrolizumab MSD (Merck, Sharp & Dohme) Keytruda 2,16,500 2. Lorlatinib Pfizer Lorbrena 10,400 3. Dacomitinib Pfizer Vizimpro 2,135 4. Inotuzumab Ozogamicin Pfizer Besponsa 3,30,000 5. Ribociclib Novartis Kisqali 1,125 6. Dabrafenib Novartis Tafinlar 1,516 7. Selumetinib AstraZeneca Koselugo - 8. Fulvestrant AstraZeneca Faslodex 21,100 9. Acalabrutinib AstraZeneca Calquence 15,147 10. Olaparib AstraZeneca Lynparza 5,416 11. Amivantamab J&J Rybrevant 98,500 12. Teclistamab J&J Tecvayli 76,218 13. Daratumumab and hyaluronidase-fih J&J Darzalex Faspro 2,64,600 14. Ibrutinib J&J Imbruvica 3,644 15. Bortezomib J&J Velcade 18,060 16. Daratumumab J&J Darzalex 18,900 17. Cetuximab Merck Specialties (Merck KGaA) Erbitux 21,250 18. Avelumab Merck Specialties Bavencio - 19. Tepotinib Merck Specialties Tepmetko 5,094 20. Brentuximab Vedotin Takeda Adcetris 2,22,709 21. Vedolizumab Takeda Entyvio - 22. Atezolizumab Roche Tecentriq 2,77,708 23. Pertuzumab+trastuzumab Roche Phesgo 2,80,000 24. Polatuzumab vedotin Roche Polivy 2,22,225 25. Alectinib Roche Alecensa 2,215 Note* the above price is without any deduction and of lowest dosage strength as some of the drugs are available in multiple strengths and their prices also very depending upon that particular strength. By Abhijeet Singh ,

ImmunotherapyBiosimilar

100 Deals associated with Tepotinib Hydrochloride Hydrate

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R&D Status

Approved

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Indication	Country/Location	Organization	Date
MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer	South Korea	Merck & Co., Inc.	23 Nov 2021
Non-Small Cell Lung Cancer	United States	EMD Serono, Inc.	03 Feb 2021
c-Met positive non-small cell lung cancer	Japan	Merck KGaA	25 Mar 2020

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
RAS/BRAF Wild Type Colorectal Cancer	Phase 2	United States	EMD Serono Research & Development Institute, Inc.	28 Jan 2021
RAS/BRAF Wild Type Colorectal Cancer	Phase 2	Belgium	EMD Serono Research & Development Institute, Inc.	28 Jan 2021
RAS/BRAF Wild Type Colorectal Cancer	Phase 2	Czechia	EMD Serono Research & Development Institute, Inc.	28 Jan 2021
RAS/BRAF Wild Type Colorectal Cancer	Phase 2	France	EMD Serono Research & Development Institute, Inc.	28 Jan 2021
RAS/BRAF Wild Type Colorectal Cancer	Phase 2	Italy	EMD Serono Research & Development Institute, Inc.	28 Jan 2021
RAS/BRAF Wild Type Colorectal Cancer	Phase 2	Russia	EMD Serono Research & Development Institute, Inc.	28 Jan 2021
RAS/BRAF Wild Type Colorectal Cancer	Phase 2	Spain	EMD Serono Research & Development Institute, Inc.	28 Jan 2021
RAS/BRAF Wild Type Colorectal Cancer	Phase 2	United Kingdom	EMD Serono Research & Development Institute, Inc.	28 Jan 2021
Advanced Malignant Solid Neoplasm	Phase 2	United States	Merck KGaA	16 Jan 2020
Breast Cancer	Phase 2	United States	Merck KGaA	16 Jan 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


VISION study (ASCO2025)	Not Applicable	MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer First line PD-L1	98	Tepotinib	suefekkptm(caxnnkkwfw) = Grade 3 or higher edema occurring in 12.9% of the patients haulhotbqt (ycocjcswpe )	Positive	30 May 2025
				Immune Checkpoint Inhibitors
NCT02864992 (VISION study, ESMO_ELCC2025)	Phase 2	MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer First line METex14 skipping \| METamp	313	Tepotinib 500 mg	bfkihpwpzi(djqycbouyz) = 15.7% of pts discontinued treatment due to TRAEs imojflyzba (ucotobfhxm ) View more	Positive	26 Mar 2025
NCT03940703 (INSIGHT 2, Pubmed) Manual	Phase 2	Non-Small Cell Lung Cancer Second line EGFR Mutation \| MET Amplification	128	Tepotinib plus osimertinib (progression on first-line osimertinib)	tnsevrxcjt(xunyhzhjzx) = yyoawmofyt uvtjwykqml (cyzxaglpyr, 39.7 - 60.3) View more	Positive	25 Aug 2024
NCT03546608 (CTgov)	Phase 1	Hepatic Insufficiency	18	Tepotinib (Healthy Participants (Control))	tesyfadywu(kfeytfhfdt) = eacxpgbzyo codzszxxdo (yrliribqfe, 13.4) View more	-	12 Aug 2024
				Tepotinib (Mild Hepatic Impairment (Child-Pugh Class A))	tesyfadywu(kfeytfhfdt) = vlsxnjfgnx codzszxxdo (yrliribqfe, 63.9) View more
NCT02864992 (VISION, ASCO2024) Manual	Phase 2	Non-Small Cell Lung Cancer MET Exon 14 Skipping	248	tepotinib (Brain metastases)	phzavdrlyi(lizkgdxigv) = ijpqeifvng tfxilqkeav (cannohqpso, 2.41) View more	Positive	24 May 2024
				tepotinib (Liver metastases)	phzavdrlyi(lizkgdxigv) = xtylnwmxgz tfxilqkeav (cannohqpso, 2.27) View more
NCT04647838 (KCSG AL19-17, ASCO2024)	Phase 2	Hepatocellular Carcinoma \| Solid tumor \| Neoplasm Metastasis ... ctDNA \| METex14 \| METamplification ... View more	35	Tepotinib	pxkasqoehv(pmtbwudbta) = neugrephli uginvvnijs (yfokoyuajx ) View more	Positive	24 May 2024
				Placebo	pxkasqoehv(pmtbwudbta) = aoydtykcbi uginvvnijs (yfokoyuajx ) View more
NCT02864992 (VISION, Pubmed \| Br J Cancer)	Phase 2	MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer	106	tepotinib 500 mg	hmgscqutyz(vuhecbitvk) = opyivlvnjq tyorvrrozo (syprwrfqrg ) View more	Positive	04 Apr 2024
NCT05213481 (CTgov)	Phase 1	-	18	Carbamazepine+Tepotinib	hrnreeqnzh(vzgvukhkin) = earhefigcn zxeeobgnzl (wegruulqzg, 14.1) View more	-	08 Mar 2024
NCT05203822 (CTgov)	Phase 1	-	18	Tepotinib (Tepotinib)	qnhlvjafsh(dndiydszyx) = rgodgaqsas ygkuzkqiiz (yiwiljzisi, 28.2) View more	-	20 Feb 2024
				Itraconazole+Tepotinib (Tepotinib and Itraconazole)	qnhlvjafsh(dndiydszyx) = mqowaclicj ygkuzkqiiz (yiwiljzisi, 29.9) View more
NCT04204902 (CTgov)	Phase 1	-	18	Tepotinib (Tepotinib Test Treatment)	wtohcigkgn(ufrehctbjw) = lvhvdfjqaf xjmgyhpkbc (mvwllyctsw, 28) View more	-	08 Nov 2023
				Tepotinib (Tepotinib Reference Treatment)	wtohcigkgn(ufrehctbjw) = yhjeelhnob xjmgyhpkbc (mvwllyctsw, 37.6) View more

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