Drugs / Tepotinib
Tepotinib
also known as
MSC2156119J · EMD 1214063 · MSC-2156119 · Tepmetko · TEPOTINIB HYDROCHLORIDE · Tepotinib hydrochloride hydrate · Tepotinib hydrochloride monohydrate
Small molecule targets MET via inhibition
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed non-small cell lung carcinoma 3 milestones | |||||
| Filed | Other | — | non-small cell lung carcinoma | 2021-02-03 | “Applications have also been submitted in Australia, Switzerland, and Canada under the FDA’s Project Orbis initiative” emdserono.com ↗ |
| Filed | US (FDA) | — | non-small cell lung carcinoma | 2020-08-25 | “today announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review to the new drug application (NDA) for once-daily, orally-dosed...” emdserono.com ↗ |
| Filed | EU (EMA) | — | non-small cell lung carcinoma | — | “A Marketing Authorization Application for tepotinib for a similar indication was validated by the European Medicines Agency in November 2020.” emdserono.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansion | US (FDA) | TEPMETKO | — | 2024-02-15 | fda.gov ↗ |
| Approved | EU (EMA) | Tepmetko | — | 2022-02-16 | europa.eu ↗ |
| Approved | US (FDA) | TEPMETKO | — | 2021-02-03 | fda.gov ↗ |
Trials 28
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 112 trials · 1 met primary | ||||||
| Phase 1 | NCT07619339 | May 2026 → May 2029 expected | non-small cell lung carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT05782361 | May 2023 → Mar 2028 expected | cancer of unknown primary site, non-small cell lung carcinoma | Institute of Cancer Research, United Kingdom | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05120960 | Feb 2023 → Apr 2024 | brain neoplasm | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT05203822 | Jan → Jul 2022 | — | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 1 | NCT05213481 | Dec 2021 → May 2022 | — | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 1 | NCT03628339 | Aug → Oct 2018 | — | Merck KGaA, Darmstadt, Germany | Completed | Met primary |
| Phase 1 | NCT03546608 | Jun 2018 → Feb 2019 | — | EMD Serono Research & Development Institute, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03492437 | May → Aug 2018 | — | Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 1 | NCT03531762 | May → Jul 2018 | — | Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 1 | NCT03021642 | Jan → Mar 2016 | — | Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 1 | NCT01832506 | Apr 2013 → Mar 2014 | cancer | Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 1 | NCT01014936 | Nov 2009 → Oct 2015 | neoplasm | EMD Serono | Completed | No outcome recorded |
| Phase 1/26 trials · 2 met primary | ||||||
| Phase 1/2 | NCT06083857 | Jun 2024 → Dec 2027 expected | non-small cell lung carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04739358 | May 2022 → Jun 2023 | — | Criterium, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT05439993 | Mar 2022 → Jun 2026 | gastric cancer, gastroesophageal cancer | Hallym University Medical Center | Unknown | No outcome recorded |
| Phase 1/2 | NCT02115373 | May 2014 → Feb 2018 | hepatocellular carcinoma | Merck KGaA, Darmstadt, Germany | Completed | Met primary |
| Phase 1/2 | NCT01988493 | Jan 2014 → Feb 2018 | hepatocellular carcinoma | Merck KGaA, Darmstadt, Germany | Completed | Met primary |
| Phase 1/2 | NCT01982955 | Dec 2013 → Dec 2017 | non-small cell lung carcinoma | Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 29 trials · 1 met primary | ||||||
| Phase 2 | NCT06031688 | Aug 2024 → May 2028 expected | non-small cell lung carcinoma | SWOG Cancer Research Network | Recruiting | No outcome recorded |
| Phase 2 | NCT06106802 | Jun 2024 → Sep 2029 expected | non-small cell lung carcinoma | Sehhoon Park | Recruiting | No outcome recorded |
| Phase 2 | NCT05159245 | Dec 2021 → Nov 2026 expected | cancer, hematopoietic and lymphoid cell neoplasm | Helsinki University Central Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04515394 | Jan 2021 → Mar 2022 | colorectal neoplasm | EMD Serono Research & Development Institute, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT04591431 | Oct 2020 → Dec 2024 | breast cancer, digestive system cancer, non-small cell lung carcinoma | Fondazione per la Medicina Personalizzata | Unknown | Met primary |
| Phase 2 | NCT04647838 | Jan 2020 → Feb 2023 | cancer | Chungbuk National University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT03940703 | Sep 2019 → May 2023 overdue | non-small cell lung carcinoma | EMD Serono Research & Development Institute, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02864992 | Sep 2016 → May 2022 overdue | lung adenocarcinoma | EMD Serono Research & Development Institute, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02925234 | Aug 2016 → Sep 2027 expected | cancer | The Netherlands Cancer Institute | Recruiting | Mixed |
| Phase 31 trial | ||||||
| Phase 3 | NCT06908993 | Dec 2025 → Mar 2028 expected | non-small cell lung carcinoma | French Cooperative Thoracic Intergroup | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 19
| Date | Issuer | Release |
|---|---|---|
| 2024-05-23 | EMD Serono Research & Development Institute, Inc. | Results EMD Serono to Showcase Advances in the Science of Cancer With New Data Presented at ASCO 2024 emdserono.com ↗
These patients experienced stable HRQoL during treatment with TEPMETKO, with trends for improvement in cough, consistent with results for the overall population. |
| 2023-05-25 | EMD Serono Research & Development Institute, Inc. | Results EMD Serono Highlights Commitment to Improving Cancer Outcomes at ASCO 2023 emdserono.com ↗ |
| 2022-09-07 | EMD Serono Research & Development Institute, Inc. | Results EMD Serono to Highlight Data at ESMO 2022 with Potential for Transformative Impact on Cancer Patients emdserono.com ↗
Among the 48 patients followed for at least three months, ORR was 45.8% (95% CI, 31.4, 60.8). |
| 2022-02-18 | EMD Serono Research & Development Institute, Inc. | Regulatory European Commission Approves TEPMETKO® (tepotinib) for Patients with Advanced NSCLC with METex14 Skipping Alterations emdserono.com ↗
TEPMETKO is the first and only oral MET inhibitor to be approved in the European Economic Area for treating adult patients with advanced NSCLC harboring alterations leading to METex14 skipping, who require systemic therapy following prior treatment |
| 2021-12-17 | EMD Serono Research & Development Institute, Inc. | Regulatory TEPMETKO® (tepotinib) Receives Positive CHMP Opinion for Patients with Advanced NSCLC with METex14 Skipping Alterations emdserono.com ↗ |
| 2021-09-12 | EMD Serono Research & Development Institute, Inc. | Results EMD Serono to Present Latest Highlights From Oncology Portfolio at WCLC and ESMO 2021 emdserono.com ↗
New results demonstrating robust and durable efficacy, and manageable safety |
| 2021-05-18 | EMD Serono Research & Development Institute, Inc. | Results Data from EMD Serono’s Oncology Portfolio Highlight Significant Advances in Cancer Care at ASCO21 emdserono.com ↗
New data from VISION study of TEPMETKO® show association between liquid biopsy-identified biomarker and clinical response in METex14 skipping NSCLC, supporting liquid biopsy as a means for monitoring treatment response |
| 2021-02-03 | EMD Serono Research & Development Institute, Inc. | Regulatory FDA Approves TEPMETKO® as the First and Only Once-daily Oral MET Inhibitor for Patients with Metastatic NSCLC with METex14 Skipping Alterations emdserono.com ↗
TEPMETKO is approved for both treatment naïve and previously treated METex14 positive NSCLC patients |
| 2020-09-14 | EMD Serono Research & Development Institute, Inc. | Results EMD Serono Advances Oncology Portfolio and Pipeline with New and Long-term Data in Multiple Cancers at ESMO 2020 emdserono.com ↗
Health-related quality of life (HRQoL) has been shown to be maintained, with clinically meaningful delays in the time to deterioration of cough, dyspnea, and chest pain (Poster #1286P) |
| 2020-08-25 | EMD Serono Research & Development Institute, Inc. | Regulatory FDA Accepts Filing of New Drug Application for Tepotinib for the Treatment of Patients with Metastatic NSCLC with METex14 Skipping Alterations emdserono.com ↗ |
| 2020-05-29 | EMD Serono Research & Development Institute, Inc. | Results New England Journal of Medicine Publishes Primary Analysis of VISION Data for Tepotinib in Advanced NSCLC with METex14 Skipping Alterations emdserono.com ↗
Results from the primary analysis of data from 99 patients with at least 9 months of follow-up demonstrate consistent response rate and durable anti-tumor activity across lines of treatment in patients assessed by both liquid biopsy (LBx) and tissue biopsy (TBx). |
| 2020-03-24 | EMD Serono Research & Development Institute, Inc. | Regulatory TEPMETKO® (Tepotinib) Approved in Japan for Advanced NSCLC with METex14 Skipping Alterations emdserono.com ↗
TEPMETKO is the first and only therapy in Japan to be approved for line-agnostic treatment of advanced non-small cell lung cancer with MET exon 14 (METex14) skipping alterations |
| 2019-11-20 | Merck KGaA, Darmstadt, Germany | Regulatory Merck KGaA, Darmstadt, Germany, Announces Orphan Drug Designation for Investigational Therapy Tepotinib in Patients with NSCLC Harboring MET Gene Alterations prnewswire.com ↗
This orphan drug designation helps to advance this program within Japan and, coupled with the SAKIGAKE 'fast-track' designation received last year, provides important mechanisms, such as priority review, to quickly deliver this medicine to Japanese patients with this difficult-to-treat disease. |
| 2019-09-11 | Merck KGaA, Darmstadt, Germany | Regulatory Merck KGaA, Darmstadt, Germany, Announces FDA Breakthrough Therapy Designation for Investigational Therapy Tepotinib in Patients with Metastatic NSCLC with METex14 Skipping Alterations prnewswire.com ↗ |
| 2019-06-03 | Merck KGaA, Darmstadt, Germany | Results Merck KGaA, Darmstadt, Germany Presents Updated Results for Investigational Therapy Tepotinib Demonstrating Durable Clinical Response in Patients with Advanced NSCLC with METex14 Skipping Mutations prnewswire.com ↗
New interim data from Phase II VISION study (all lines of treatment) show tepotinib induced objective responses, as assessed by independent review, in 50.0% of patients identified by liquid biopsy (LBx) and 45.1% for patients identified by tissue biopsy (TBx) |
| 2018-06-11 | Merck KGaA, Darmstadt, Germany | Results Merck KGaA, Darmstadt, Germany Provides Update on Tepotinib Phase II Results in Advanced Hepatocellular Carcinoma prnewswire.com ↗
Both studies met their primary endpoint. |
| 2018-06-03 | Merck KGaA, Darmstadt, Germany | Results Merck KGaA, Darmstadt, Germany Presents Update on Tepotinib in Advanced Lung Cancer at ASCO 2018 prnewswire.com ↗
Data from an ongoing Phase II tepotinib study show anti-tumor clinical activity in patients with advanced non-small cell lung cancer harboring MET exon 14 skipping mutations |
| 2018-05-17 | Merck KGaA, Darmstadt, Germany | Results Merck Data at ASCO 2018 to Showcase Progress and Further Optionality of Oncology Pipeline prnewswire.com ↗
Encouraging interim analysis of Phase II data in NSCLC sub-population for c-Met inhibitor, tepotinib |
| 2018-05-16 | Merck KGaA, Darmstadt, Germany | Results Merck KGaA, Darmstadt, Germany Data at ASCO 2018 to Showcase Progress and Further Optionality of Oncology Pipeline prnewswire.com ↗
Encouraging interim analysis of Phase II data in NSCLC sub-population for investigational c-Met inhibitor, tepotinib |
All press releases naming this drug 19 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 30 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tepotinib | “Tepotinib (MSC2156119J) is an oral, potent and highly selective small molecule” PMID 32328660 ↗ Aug 2020 |
| Known as | EMD 1214063 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3402762 ↗ |
| Known as | MSC-2156119 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3402762 ↗ |
| Known as | MSC2156119J | “A Phase Ib/II Multicenter, Randomized, Open Label Trial to Compare Tepotinib (MSC2156119J) Combined With Gefitinib Versus Chemotherapy as Second-Line Treatment” NCT01982955 ↗2“Tepotinib (MSC2156119J) is an oral, potent and highly selective small molecule” PMID 32328660 ↗ Aug 2020 |
| Known as | Tepmetko | ChEMBL registry synonym — accepted as the source's own label CHEMBL3402762 ↗ |
| Known as | TEPOTINIB HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3402762 ↗ |
| Known as | Tepotinib hydrochloride hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3402762 ↗ |
| Known as | Tepotinib hydrochloride monohydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3402762 ↗ |
| Action | Inhibit | “MET inhibitor” NCT01832506 ↗ |
| Modality | Small molecule | “small molecule mesenchymal-epithelial transition factor (MET) inhibitor” PMID 32328660 ↗ Aug 2020 |
| Route | Oral | “Tepotinib (MSC2156119J) is an oral” PMID 32328660 ↗ Aug 2020 |
| Target | MET | “MET inhibitor” NCT01832506 ↗ |