2022-06-23| Trials & Approvals

Novartis’s Lung Cancer Drug Approved for Marketing in Europe

by Joy Lin
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The European Commission has given the greenlight to Novartis’ Tabrecta (capmatinib), providing a subpopulation of patients in Europe with non-small cell lung cancer (NSCLC) a new targeted therapy option. 

Tabrecta will be given as a monotherapy to treat adults with advanced NSCLC who have gene mutations leading to mesenchymal-epithelial-transition factor gene (MET) exon 14 (METex14) skipping. The drug will only be used on patients requiring systemic therapy after prior treatment with immunotherapy and/or platinum-based chemotherapy. 

The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). It is applicable to all 27 EU member states plus Iceland, Norway and Liechtenstein. 


Overall Response Rate of 51.6% in Second-Line Cohort


The EU nod is based on results from the Phase 2 Geometry mono-1 trial showing positive overall response rates (ORR) in advanced NSCLC patients with METex14 skipping. In the trial, patients who received Tabrecta as second-line or later treatment had an ORR of 51.6%, while the ORR of all previously-treated patients was 44%. 

Side effects of the medication include peripheral swelling, nausea, fatigue, increased blood creatine, vomiting, shortness of breath, decreased appetite and back pain. 

There are around 291,000 patients with locally advanced or metastatic NSCLC in the EU. METex14 skipping occurs in around 3-4% of NSCLC cases. 

Patients with METex14 skipping alterations typically have a more advanced form of lung cancer often associated with poor prognosis and limited response to standard therapy such as immunotherapy, said Juergen Wolf, MD, from the Center for Integrated Oncology, University Hospital Cologne, Germany. 

Wolf, also the lead investigator of the Geometry mono-1 trial, added that the EU approval of Tabrecta, with support from advances in biomarker testing, could help doctors direct treatment more precisely and give the patient subpopulation a new targeted treatment option that can lead to improved outcomes. 

Related article: Novartis and Samsung Biologics Sign Low-Profile $81 Million Deal 


Approved Drugs for METex14 Skipping


Tabrecta is a kinase inhibitor that targets MET. Discovered by Incyte, the drug was licensed to Novartis in 2009. Since then, it has been approved in the EU, US, Switzerland and Japan. 

In 2020, Tabrecta received its first approval in the US to treat metastatic NSCLC with METex14 skipping, the first in its drug class. 

Tetmeko (tepotinib), developed by Merck for METex14 skipping, followed Tabrecta in obtaining US approval in February 2021. Tetmeko was also recently approved in the EU this February, and is expected to compete with Tabrecta in treating this patient group. 

Meanwhile in China, the first and only approval for this drug class goes to AstraZeneca and Hutchmed’s oral MET inhibitor Orpathys (savolitinib).

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