Novartis announces MET inhibitor Tabrecta approved in Japan for advanced non-small cell lung cancer with METex14

On Jun 30, 2020

Novartis Pharma K.K. announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved Tabrecta (capmatinib, formerly INC280), an oral MET inhibitor for MET exon 14 skipping (METex14) mutation-positive advanced and/or recurrent unresectable non-small cell lung cancer (NSCLC). Tabrecta is approved for first-line and previously treated patients, regardless of prior treatment type.

“With the remarkable overall response rates seen both in treatment-naive and previously treated patients, we are thrilled that MHLW has added Tabrecta as a new treatment option for patients with advanced NSCLC with METex14,” said Brian Gladsden, President of Novartis Oncology Japan. “Today’s approval reinforces the potential benefit this new MET inhibitor can bring to thousands of patients diagnosed in Japan each year and is a positive step in our journey to transform the lives of patients with lung cancer.”

The approval of Tabrecta is based on results from the pivotal GEOMETRY mono-1 Phase II multi-center, non-randomized, open-label, multi-cohort study. In the METex14 population (n=97), the confirmed overall response rate was 68% (95% CI, 48-84) and 41% (95% CI, 29-53) among treatment-naive (n=28) and previously treated patients (n=69), respectively, based on the Blinded Independent Review Committee (BIRC) assessment per RECIST v1.1. In patients taking Tabrecta, the study also demonstrated a median duration of response of 12.6 months (95% CI, 5.5–25.3) in treatment-naive patients (19 responders) and 9.7 months (95% CI, 5.5-13.0) in previously treated patients (28 responders). The most common treatment-related adverse events (AEs) (incidence ≥20%) are peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite.

The companion diagnostic to Tabrecta, FoundationOne^®CDx Cancer Genomic Profile, was approved by MHLW on May 25^thof this year, to aid in detecting mutations that lead to MET exon 14 skipping in tumor tissue.