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Tabrecta

(Capmatinib)

ApprovedSmall molecule

Capmatinib is used to treat a type of lung cancer called non-small cell lung cancer that has a specific genetic mutation called MET exon 14 skipping. It works by blocking a protein that helps cancer cells grow.[2] Tabrecta is currently approved and in use across 12 indications[4].[1]

Tabrecta is one of 336 small molecule programs targeting Lung Cancer. It is currently in Approved.

12

Indications

31

Total Trials

8

Active Trials

335

Competitors

6

FDA Applications

NDA/BLA/ANDA regulatory filings

7

Patents

Pipeline

Status by Indication[4][1]

Indication

Lung CancerApproved

Hepatocellular CarcinomaApproved

Liver DiseaseApproved

Kidney CancerApproved

Non-Small Cell Lung CarcinomaActive, not recruiting

Haematological MalignancyRecruiting

Pediatric CancerRecruiting

Carcinoma, Non-Small-Cell LungActive, not recruiting

Advanced Soft-Tissue SarcomaActive, not recruiting

Non-Small Cell Lung CancerTerminated

Lung CancerApproved

Approved

Hepatocellular CarcinomaApproved

Approved

Liver DiseaseApproved

Approved

Kidney CancerApproved

Approved

Non-Small Cell Lung CarcinomaApproved

Active, not recruiting

Haematological MalignancyPreclinical

Recruiting

Pediatric CancerPreclinical

Recruiting

Carcinoma, Non-Small-Cell LungPreclinical

Active, not recruiting

Advanced Soft-Tissue SarcomaPhase 3

Active, not recruiting

Non-Small Cell Lung CancerPhase 3

Terminated

Showing 10 of 12 indications

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Tabrecta

ONO-4538

Ono Pharmaceutical Co. Ltd

SCTB14

SSinocelltech Ltd.

Remeron

OOrganon and Co

Treatment

Valemetostat Tosylate

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

PD-1 Inhibitors

BBioNTech US Inc.

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2Not yet recruiting

MET Exon 14 Mutation

NCT06054191

Q2 2027

PreclinicalActive, not recruiting

Carcinoma, Non-Small-Cell Lung

NCT05488314

Phase 2Recruiting

Non-Small Cell Lung Cancer

NCT05642572

Q3 2027

Phase 2Active, not recruiting

Solid Tumor

NCT03040973

Q4 2029

Phase 2/3Recruiting

Treatment

NCT06988475

PreclinicalRecruiting

Haematological Malignancy

NCT05722886

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer8 trials

Study of Capmatinib and Spartalizumab Combination Therapy vs Docetaxel in Non-small Cell Lung Cancer

Completed· Novartis logo

Novartis·Phase 2·NCT03647488·18 enrolled

Study of Oral cMET Inhibitor INC280 in Patients With EGFR Wild-type (wt), Advanced Non-small Cell Lung Cancer (NSCLC) (Geometry Mono-1)

Completed· Novartis logo

Novartis·Phase 2·NCT02414139·373 enrolled

Comparing Combinations of Targeted Drugs for Advanced Non-Small Cell Lung Cancer That Has EGFR and MET Gene Changes (A Lung-MAP Treatment Trial)

Recruiting·SSWOG Cancer Research Network·Phase 2·NCT05642572·66 enrolled

Show 5 more trials

Capmatinib Plus Trametinib for the Treatment of Metastatic Non-small Cell Lung Cancer With MET Exon 14 Skipping Mutation

Terminated·CCollin Blakely·Phase 1·NCT05435846·3 enrolled

Study Evaluating Efficacy and Safety of Capmatinib in Combination With Osimertinib in Adult Subjects With Non-small Cell Lung Cancers as Second Line Therapy

Terminated· Novartis logo

Novartis·Phase 3·NCT04816214·6 enrolled

Capmatinib in Patients With Non-small Cell Lung Cancer Harboring cMET exon14 Skipping Mutation

Unknown status·—·Phase 2·NCT03693339·27 enrolled

Study of Capmatinib in Chinese Adult Patients With Advanced Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation

Completed· Novartis logo

Novartis·Phase 2·NCT04677595·37 enrolled

Study of Capmatinib Efficacy in Comparison With Docetaxel in Previously Treated Participants With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation

Terminated· Novartis logo

Novartis·Phase 3·NCT04427072·22 enrolled

MET Exon 14 Skipping Mutation4 trials

Study of Capmatinib in Indian Patients With MET Exon 14 Skipping Mutation Positive Advanced NSCLC.

Completed· Novartis logo

Novartis·Phase 4·NCT05110196·50 enrolled

Study of Capmatinib and Spartalizumab/Placebo in Advanced NSCLC Patients With MET Exon 14 Skipping Mutations

Terminated· Novartis logo

Novartis·Phase 2·NCT04323436·31 enrolled

A Phase II, Open-Label, Multicenter Study of Capmatinib in Subjects With MET Exon 14 Skipping Mutation Positive, Advanced, NSCLC With Brain Metastases

Withdrawn· Novartis logo

Novartis·Phase 2·NCT04460729

Show 1 more trial

Real-World Assessment of Clinical Outcomes in Metastatic NSCLC Patients With MET Exon 14 Skipping Mutation and Brain Metastases Treated With Capmatinib

Completed· Novartis logo

Novartis··NCT05675683·68 enrolled

Breast Cancer2 trials

Neratinib and Capmatinib Combination (Phase Ib/II) in Metastatic Breast Cancer and Inflammatory Breast Cancer Patients With Abnormal HER-family and c-Met Pathway Activity as Measured by the CELsignia Signaling Analysis Test

Terminated·MM.D. Anderson Cancer Center·Phase 1/2·NCT05243641·10 enrolled

Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC).

Terminated· Novartis logo

Novartis·Phase 1·NCT03742349·64 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of Capmatinib (INC280) Plus Pembrolizumab vs Pembrolizumab Alone in NSCLC With PD-L1≥ 50%

Terminated· Novartis logo

Novartis·Phase 2·NCT04139317·76 enrolled

Aged1 trial

Managed Access Programs for INC280, Capmatinib

No longer available· Novartis logo

Novartis··NCT04741789

15 more indications

Effectiveness1 trial

RW Effectiveness of Capmatinib in Advanced MET-dysregulated NSCLC Included in the French Compassionate Use Program (ATU)

Completed·IIntergroupe Francophone de Cancerologie Thoracique··NCT05154344·182 enrolled

Neoadjuvant1 trial

Phase II of Neoadjuvant and Adjuvant Capmatinib in NSCLC

Terminated· Novartis logo

Novartis·Phase 2·NCT04926831·4 enrolled

NSCLC1 trial

A Study of Capmatinib (INC280) in NSCLC Patients With MET Exon 14 Alterations Who Have Received Prior MET Inhibitor

Completed·MMassachusetts General Hospital·Phase 2·NCT02750215·20 enrolled

MET Exon 14 Mutation1 trial

Neoadjuvant and Adjuvant Targeted Treatment in NSCLC With BRAF V600 or MET Exon 14 Mutations

Not yet recruiting·SSun Yat-sen University·Phase 2·NCT06054191·40 enrolled

Small Cell Lung Cancer1 trial

Study of Safety and Efficacy of EGFR-TKI EGF816 in Combination With cMET Inhibitor INC280 in Adult Patients With EGFR Mutated Non Small Cell Lung Cancer.

Terminated· Novartis logo

Novartis·Phase 1/2·NCT02335944·177 enrolled

Advanced1 trial

Phase Ib/II Study of INC280 + PDR001 or PDR001 Single Agent in Advanced HCC

Completed· Novartis logo

Novartis·Phase 1/2·NCT02795429·89 enrolled

Melanoma1 trial

Capmatinib, Ceritinib, Regorafenib, or Entrectinib in Treating Patients With BRAF/NRAS Wild-Type Stage III-IV Melanoma

Terminated·UUniversity of California, San Francisco·Phase 2·NCT02587650·1 enrolled

Treatment1 trial

DETERMINE Trial Treatment Arm 06: Capmatinib in Adult Patients With Cancers Harbouring MET Dysregulations

Recruiting·CCancer Research UK·Phase 2/3·NCT06988475·30 enrolled

Advanced Soft-tissue Sarcoma1 trial

Molecular Profiling of Advanced Soft-tissue Sarcomas

Active, not recruiting·IInstitut National de la Santé Et de la Recherche Médicale, France·Phase 3·NCT03784014·603 enrolled

Gastric Adenocarcinoma1 trial

Combination of Capmatinib + Spartalizumab in Advanced Oesogastric Adenocarcinoma

Suspended·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT05135845·90 enrolled

Central Nervous System1 trial

Central Nervous System Efficacy of Capmatinib in NSCLC With Brain Metastases With cfDNA Positive MET Alterations

Withdrawn·—·Phase 2·NCT05567055

Solid Tumor1 trial

An Open-label, Multi-center, Global, Rollover Study for Patients Who Have Previously Been Treated With Capmatinib (INC280) as Monotherapy or in Combination in a Novartis Sponsored Trial.

Active, not recruiting· Novartis logo

Novartis·Phase 2·NCT03040973·29 enrolled

Carcinoma, Non-Small-Cell Lung1 trial

A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Preclinical·NCT05488314·57 enrolled

Pediatric Cancer1 trial

European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors

Recruiting·GGustave Roussy, Cancer Campus, Grand Paris·Preclinical·NCT02813135·472 enrolled

Haematological Malignancy1 trial

DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage/Young Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations

Recruiting·CCancer Research UK·Preclinical·NCT05722886·825 enrolled

Regulatory

FDA Approval Timeline[5]

May 6, 2020

TABRECTA

NDA NDA213591

May 6, 2020

TABRECTA

NDA NDA213591

Jan 21, 2022

TABRECTA

NDA NDA213591

Aug 10, 2022

TABRECTA

NDA NDA213591

Mar 24, 2023

TABRECTA

NDA NDA213591

Mar 14, 2024

TABRECTA

NDA NDA213591

Sources

References

[1]
ClinicalTrials.gov — 31 trial records for Capmatinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Tabrecta drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Capmatinib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Capmatinib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA213591). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Tabrecta. U.S. Food & Drug Administration.
[7]
PubMed — 1 publication indexed for Capmatinib. U.S. National Library of Medicine.
[8]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: MET Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Novartis

Patent Landscape[6]

Patent Cliff

Nov 19, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8461330Nov 19, 2027

12084449Nov 19, 2027

8901123May 20, 2029

8420645Jun 5, 2031

7767675Nov 19, 2032

2 more patents

10596178Jul 22, 2035

12208101Jul 22, 2035

Key Publications[7]

Capmatinib in MET Exon 14-Altered NSCLC: GEOMETRY mono-1

N Engl J MedMay 6, 2022DOI: 10.1056/NEJMoa2115028

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