The Food and Drug Administration, the FDA, has granted capmatinib a “breakthrough therapy” designation as a first-line treatment for Non-Small Cell Lung Cancer (NSCLC) patients with MET mutation, EGFR Wild-type and their disease is in advanced stages – stages IIIb, IV – were it is locally spread or has sent metastases to distant organs.
The capmatinib is taken orally and selectively binds to c-Met.
96.4% of patients had responded to capmatinib
The designation comes as a result of the positive results seen in the GEOMETRY mono-1 trial presented at the 2019 ASCO Annual Meeting. The results demonstrated that 96.4% of patients had responded to capmatinib!
On breakthrough designation –
An FDA breakthrough therapy designation acknowledges that the drug targets a serious or life-threatening disease and shows improvement over existing treatments, the standard protocols. The MET gene has been concluded to be a driver of NSCLC. The mutation in this gene occurs in about 3% to 4% of all cases of NSCLC and is associated with a poor prognosis.
The designation also allows for expedited development and regulatory review of the agent by the FDA.
Trial results –
Among the pretreated patients, the disease control rate, DCR, was close to 80%. The median duration of response, DOR, was close to 10 months and the median time was close to 5.5 months.
In the treatment-naïve cohort, the DCR was 96.4%! The median DOR was 11.14 months and the median PFS was 9.69 months.
Peripheral edema was the most common side event (7.5%) followed by fatigue (3.0%).
The best treatment for a cancer patient is to get the most advanced cancer drugs in advanced stages of development. There, the hope and the chance to extend life go far beyond the standard protocols.
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