Tabrecta(capmatinib)

Oncology· 1234 cited findings· 1 source document

What the regulatory reviews say

Tabrecta (capmatinib) is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a mesenchymal-epithelial transition (MET) exon 14 skipping mutation. The CHMP positive opinion specifies its use as monotherapy for adult patients with advanced NSCLC harboring alterations leading to METex14 skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

Key efficacy findings include a median overall survival (OS) of 20.76 months. For METex14 NSCLC patients without a MET inhibitor, median OS ranged from 8 to 11 months. The overall survival hazard ratio for METex14 in NSCLC was 1.82, and 2.156 in multi-variate analysis. The overall survival hazard ratio for high-level MET amplification in NSCLC was 3.444 in multi-variate analysis. Complete response (CR) was observed in 2% of patients, with various partial response (PR) rates reported (27%, 16%, 17%, 21%). Disease control rates (DCR) were reported as 54%, 28%, 27%, and 32%.

Regarding safety, the overall incidence of Grade ≥3 adverse events was 70.2%, and serious adverse events (SAEs) occurred in 53.1% of all patients (n=373). The frequency of treatment discontinuations was 17%. Capmatinib received approval on 6-May-2020.

Key figures — cited to the source page

Median OS (months)	20.76	Novartis AG — Tabrecta EMA EPAR public assessment report (EM, p.101
Median OS of METex14 NSCLC patients (no MET inhibitor)	8 to 11	Novartis AG — Tabrecta EMA EPAR public assessment report (EM, p.155
CR	2	Novartis AG — Tabrecta EMA EPAR public assessment report (EM, p.94
overall incidence of Grade ≥3 adverse events	70.2	Novartis AG — Tabrecta EMA EPAR public assessment report (EM, p.159
overall incidence of serious AEs	53.1	Novartis AG — Tabrecta EMA EPAR public assessment report (EM, p.159
frequency of treatment discontinuations	17	Novartis AG — Tabrecta EMA EPAR public assessment report (EM, p.160
Capmatinib approval date	6-May-2020	Novartis AG — Tabrecta EMA EPAR public assessment report (EM, p.147
CHMP positive opinion date	22 April 2022	Novartis AG — Tabrecta EMA EPAR public assessment report (EM, p.9

Source documents

Novartis AG — Tabrecta EMA EPAR public assessment report (EMEA/H/C/004845, 2022) (2022)

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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.