FDA Approves Companion Diagnostic for Tepotinib in mNSCLC with MET Exon 14 Skipping Alterations
核心洞察
The FDA approved FoundationOne Liquid CDx as a companion diagnostic for tepotinib, aiding in identifying mNSCLC (搜索) patients with MET exon 14 (搜索) skipping alterations.
Tepotinib received regular approval in February 2024 for mNSCLC (搜索) patients with MET exon 14 (搜索) skipping alterations, following an earlier accelerated approval in 2021.
Phase 2 VISION trial data supported tepotinib's approval, demonstrating overall response rates of 57% in treatment-naive and 45% in previously treated patients.
The FDA has approved FoundationOne Liquid CDx as a companion diagnostic to identify patients with metastatic non-small cell lung cancer (搜索) (mNSCLC (搜索)) harboring MET exon 14 skipping alterations who may be eligible for treatment with tepotinib (Tepmetko). This approval expands access to precision medicine for NSCLC patients.
Tepotinib's Approval History
On February 15, 2024, the FDA granted regular approval to tepotinib for adult patients with mNSCLC (搜索) harboring MET exon 14 skipping alterations. This followed the accelerated approval of the agent in February 2021 for the same indication. The approvals were based on data from the phase 2 VISION trial (NCT02864992).
Clinical Efficacy from the VISION Trial
The VISION trial evaluated tepotinib at a dose of 450 mg once daily in 313 patients with mNSCLC (搜索) harboring MET exon 14 skipping alterations. The primary efficacy endpoints were overall response rate (ORR) and duration of response (DOR). In 164 previously untreated patients, the ORR was 57% (95% CI, 49%-65%), with 40% of responders maintaining a DOR of at least 12 months. Among 149 previously treated patients, the ORR was 45% (95% CI, 37%-53%), and 36% of responders had a DOR of at least 12 months.
Long-term efficacy findings showed a median progression-free survival (PFS) of 12.6 months (95% CI, 9.7-17.7) in the treatment-naive cohort, with 12- and 24-month PFS rates of 52% (95% CI, 43.0%-60.0%) and 38% (95% CI, 29.0%-47.0%), respectively. In the previously treated cohort, the median PFS was 15.9 months (95% CI, 11.0-49.7), and the respective 12- and 24-month PFS rates were 59% (95% CI, 48.0%-69.0%) and 42% (95% CI, 30.0%-53.0%).
The median overall survival was 21.3 months (95% CI, 14.2-25.9) in treatment-naive patients and 29.7 months (18.8-not evaluable) in previously treated patients.
Safety Profile
A pooled safety analysis of 448 patients with solid tumors, including 255 from the VISION trial, revealed that 45% experienced serious adverse effects (AEs). The most common serious AEs included pleural effusion (7%), pneumonia (5%), and dyspnea (3.9%). Common AEs included edema, nausea, fatigue, and musculoskeletal pain.