Last month (February 2020), the US FDA granted priority review for capmatinib, a treatment being investigated for advanced non-small cell lung cancer (NSCLC) with a METex14 amplification and/or mutation. If approved, this would be the first drug on the market targeting this specific mutation. The FDA will review capmatinib in six months (instead of the 10-month standard review timeline).
Introduction to non-small cell lung cancer and the METex14 mutation
NSCLC accounts for about 85% of all lung cancer cases. Cases with a specific genetic mutation called “METex14” account for approximately 3-4% of all newly diagnosed advanced NSCLC cases. METex14 mutation is an oncogenic driver (meaning a mutation that is responsible for both the initiation and maintenance of cancer) and leads to a particularly poor prognosis, since there are currently no approved treatments to target this specific mutation.
Potential new treatment for METex14 advanced non-small cell lung cancer
If approved by the FDA, capmatinib, a potent MET inhibitor, could become the first potential targeted therapy filling the gap for the treatment of METex14 mutated advanced NSCLC. It is an oral drug, which could be attractive to many patients compared to other treatments, which require injections, infusions, and time spent in a hospital. Additionally, the drug is highly specific, so while it is very potent and directed at MET, toxicity of treatment is expected to be limited, a key potential advantage of this treatment [2].
Spotlight on the research on capmatinib for NSCLC so far:
A phase II clinical trial (GEOMETRY mono-1) [3] investigated the efficacy of the capmatinib treatment in both treatment-naïve and previously treated patients. All the 94 adult patients enrolled had advanced or metastatic METex14 mutated NSCLC.
The data showed some encouraging results:
Overall Response Rate (ORR) = proportion of patients in a trial whose tumor is destroyed or significantly reduced by a drug
- 67.9% of the patients who had not received any prior treatment showed a positive response to the drug.
- 40.6% of the patients who had already received another treatment showed a positive response to the drug.
Durable response = a long-lasting positive reaction to cancer therapy
- The treatment provided a durable response, which lasted an average of 11.14 months, in patients who had not received any prior treatment.
- The treatment provided a durable response, which lasted an average of 9.72 months, in patients who had already received another treatment prior to the trial.
Capmatinib could be approved by September 2020 and would be a major treatment advance for patients with this particularly aggressive form of lung cancer.
Check back on Ancora for the latest clinical trials and lung cancer news, our team will keep you posted.
References
- Novartis announces MET inhibitor capmatinib (INC280), the first potential treatment for METex14 mutated advanced non-small cell lung cancer, granted priority FDA review | Novartis | Accessed: 2020-03-24
- FDA Priority Review of Capmatinib for METex14-Mutated NSCLC | Accessed: 2020-03-23
- Incyte Announces Acceptance and Priority Review of NDA for Capmatinib for Advanced Non-Small Cell Lung Cancer | BioSpace | Accessed: 2020-03-23