Tabrecta (capmatinib)
Tabrecta has been approved for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a MET exon 14 skipping mutation. Tabrecta contains the active ingredient capmatinib.
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer and accounts for about 85% of all lung cancer cases.
Tabrecta has been approved to treat adults with locally advanced or metastatic NSCLC whose cancer has a specific genetic change in the MET gene called an ‘exon 14 skipping’ mutation. This mutation produces an abnormal version of the MET protein and contributes to NSCLC development in around 2% to 4% of NSCLC cases.
The MET protein normally regulates cell growth, survival, movement, and repair. In NSCLC cancers with the mutated MET protein (produced from the exon 14 skipped version of the MET gene), the MET signal remains active. This continuously sends growth and survival signals to the cell, which can drive cancer growth.
NCSLC cancer cells are highly reliant on MET for growth. Tabrecta blocks the activity of MET, switching off this growth signal, which may lead to slowing or shrinkage of the tumour.
The main study used to assess how well Tabrecta works was a large international clinical trial called GEOMETRY mono-1.
A total of 373 patients participated in the study. The study included patients who had not received previous treatments and patients who had already been treated with other cancer medicines. Patients were also grouped according to the presence and/or type of MET change in their cancer.
The main goal of the study was to measure the overall response rate (ORR) in NSCLC patients with the exon 14 skipped version of the MET gene. The ORR is the percentage of patients whose cancer either became smaller or was undetectable after treatment with Tabrecta.
Another important measure assessed in the study was the duration of response (DoR). DoR measures how long the treatment continued to work before the cancer started getting worse
Key findings from the clinical study
- In NSCLC patients with the exon 14 skipped version of the MET gene who had not received previous treatment, Tabrecta was considered effective if an ORR of at least 55% was achieved. This target was met: the ORR was 68.3% in these patients.
- In NSCLC patients with the exon 14 skipped version of the MET gene who had received previous treatment, Tabrecta was considered effective if an ORR of at least 35% was achieved. This target was met: the ORR was 44.0% in these patients.
- In patients with the exon 14 skipped version of the MET gene, the DoR was 16.6 months in previously untreated patients and 9.7 months in patients who had received prior treatments.
- Across all patients in the study, the most common side effects were swelling in the arms or legs (peripheral oedema), nausea, vomiting, increased creatinine in the blood (a possible sign of kidney effects), and shortness of breath.
- The side effects in patients with MET-mutated NSCLC were similar in how often they happened and how serious they were compared with the other study groups. However, swelling in the arms or legs was reported more often in previously untreated patients with the MET exon 14 skipping mutation compared to patients without this mutation.
- Side effects of special interest included liver problems, kidney problems, effects on the brain or nervous system, and pancreatitis (inflammation of the pancreas). A small number of patients also developed interstitial lung disease or pneumonitis, which are serious lung conditions.
- There were 12 serious side effects that resulted in death during the study. Investigators considered 4 of these deaths to be related to Tabrecta. These included 1 case of pneumonitis, 1 case of organising pneumonia, 1 cardiac arrest, and 1 case of hepatitis.
The TGA decided that the application provided sufficient evidence supporting the safety and effectiveness of Tabrecta and the medicine can be registered in Australia.
More detailed information on why the TGA approved Tabrecta will be published in the upcoming Australian Public Assessment Report (AusPAR).
For comprehensive information on potential side effects and risks, refer to the Consumer Medicine Information (CMI) leaflet or Product Information (PI) document.
This decision summary will not be updated to reflect any subsequent changes and may therefore not contain the most current information about the medicine. For the latest information, refer to the medicine’s CMI or PI.
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
The Australian CMI for Tabrecta can be accessed through the searchable TGA eBusiness Services or ARTG databases.
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
The Australian PI for Tabrecta can be accessed through the searchable TGA eBusiness Services or ARTG databases.
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