Safety and effectiveness of tepotinib in patients with unresectable, advanced or recurrent non-small cell lung cancer with METex14 skipping alterations: post-marketing surveillance in Japan.

Abstract

Objective: Tepotinib has shown clinical benefits in patients with non-small cell lung cancer (NSCLC) harboring MET exon 14 (METex14) skipping alterations. The objective of this post-marketing surveillance (PMS) was to assess the safety and effectiveness of tepotinib in general clinical practice in Japan.

Methods: This multicenter, non-interventional PMS included patients with unresectable, advanced, or recurrent NSCLC with METex14 skipping alterations who received at least one dose of tepotinib. The primary endpoint was the incidence of adverse drug reactions (ADRs) identified as safety specifications (SS) for tepotinib according to the Japanese Risk Management Plan (ADRs of SS); i.e. interstitial lung disease (ILD), fluid retention, hepatic function disorder, renal impairment, and QT interval prolongation (classified by preferred term). The secondary endpoints were ADRs of SS in patient subgroups and the effectiveness of tepotinib in clinical practice. In total, 147 patients were included (median age 72.0 years).

Results: The incidence of ILD, fluid retention, hepatic function disorder, and renal impairment was 7.5%, 47.6%, 13.6%, and 36.1%, respectively; incidence of grade ≥3 ADRs of SS were 3.4%, 9.5%, 4.8%, and 2.7%, respectively. No instances of QT interval prolongation occurred. Four patients (2.7%) died due to ILD. The objective response rate was 51.0% [95% confidence interval (CI) 42.7, 59.3] and disease control rate was 77.6% (95% CI 69.9, 84.0).

Conclusions: Tepotinib was generally well tolerated and effective in patients with NSCLC and METex14 skipping alterations in general clinical practice in Japan; no new safety issues or concerns were identified.