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FDA Approval Summary: Capmatinib and Tepotinib for the Treatment of Metastatic NSCLC Harboring MET Exon 14 Skipping Mutations or Alterations

Cette étude analyse les données de l’essai clinique ayant conduit la FDA à autoriser l'utilisation du capmatinib et du tépotinib pour traiter les patients atteints d'un cancer métastatique du poumon non à petites cellules présentant une mutation ou une altération du gène MET (perte de l'exon 14)

The Food and Drug Administration (FDA) approved capmatinib and tepotinib on May 6, 2020, and February 3, 2021, respectively. Capmatinib is indicated for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors have a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. Tepotinib is indicated for mNSCLC harboring MET exon 14 skipping alterations. The approvals were based on trials GEOMETRY mono-1 (capmatinib) and VISION (tepotinib). In GEOMETRY mono-1, overall response rate (ORR) per Blinded Independent Review Committee (BIRC) was 68% (95% confidence interval [CI]: 48, 84) with median duration of response (DoR) 12.6 months (95% CI: 5.5, 25.3) in 28 treatment-naïve patients and 41% (95% CI: 29, 53) with median DoR 9.7 months (95% CI: 5.5, 13) in 69 previously-treated patients with NSCLC with mutations leading to MET exon 14 skipping. In VISION, ORR per BIRC was 43% (95% CI: 32, 56) with median DoR 10.8 months (95% CI: 6.9, not estimable) in 69 treatment-naïve patients and 43% (95% CI: 33, 55) with median DoR 11.1 months (95% CI: 9.5, 18.5) in 83 previously-treated patients with NSCLC harboring MET exon 14 alterations. These are the first two therapies to be FDA-approved specifically for patients with metastatic NSCLC with MET exon 14 skipping.

Clinical Cancer Research 2021

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