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Association details:
Evidence:
Evidence Level:
Sensitive: A1 - Approval
New
Source:
Title:

NMPA conditionally approves gumarontinib for treatment of non-small cell lung cancer with MET Exon 14 skipping mutation

Published date:
03/08/2023
Excerpt:
Gumarontinib, an oral highly selective mesenchymal-epithelial transition (MET) inhibitor and a Category 1 innovative new chemical drug, for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET exon 14 skipping mutation got conditional approval on March 8, 2023, by the National Medical Products Administration (NMPA) of China.
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Study to Evaluate the Safety and Anti-tumor Activity of SCC244

Excerpt:
...In Phase Ia, histologically confirmed NSCLC (including sarcomatoid carcinoma) with c-Met alterations defined as c-Met gene amplification ≥ 5 copies or c-Met protein overexpression (IHC 3+) or c-Met exon 14 skipping mutation....
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Gumarontinib in patients with non-small-cell lung cancer harbouring MET exon 14 skipping mutations: a multicentre, single-arm, open-label, phase 1b/2 trial

Published date:
04/06/2023
Excerpt:
The single-arm, multicentre, open-label, phase 2 stage of the GLORY study was conducted at 42 centres across China and Japan. Adults with locally advanced or metastatic METex14-positive NSCLC received oral gumarontinib….The objective response rate was 66% (95% CI 54-76) overall (n = 79), 71% (95% CI 55-83) in treatment-naïve patients (n = 44), and 60% (95% CI 42-76) in previously-treated patients (n = 35)....Gumarontinib monotherapy had durable antitumour activity with manageable toxicity in patients with locally advanced or metastatic METex14-positive NSCLC when used in first line or later.
DOI:
https://doi.org/10.1016/j.eclinm.2023.101952
Trial ID: