Dr Paik on the Full FDA Approval of Tepotinib for mNSCLC Harboring MET Exon 14 Skipping Alterations

Paul K. Paik, MD, clinical director, Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center, discusses the significance of the FDA approval of tepotinib (Tepmetko) for patients with metastatic non–small cell lung cancer (mNSCLC) harboring MET exon 14 skipping alterations.

On February 15, 2024, the FDA granted full approval to tepotinib for the treatment of adult patients with mNSCLC harboring MET exon 14 skipping alterations. This regulatory decision follows the accelerated approval of the agent in 2021 for this indication based on initial findings from the single-arm, phase 2 VISION trial (NCT02864992).

The full approval of tepotinib for this population validates the initial accelerated approval, Paik says. In the initial readout of the trial, treatment with tepotinib led to an overall response rate (ORR) of 43% (95% CI, 32%-56%) among 69 previously untreated patients. The FDA’s conversion to a full approval was supported by data from an additional 161 patients enrolled in VISION, which is one of the largest prospective clinical trials investigating a MET inhibitor in patients with mNSCLC harboring MET exon 14 skipping alterations, having enrolled 313 patients, Paik explains. With 28 months of additional follow-up, the efficacy with tepotinib has increased, Paik emphasizes. Tepotinib generated an ORR of 57% (95% CI, 49%-65%) in evaluable treatment-naive patients (n = 164) and 45% (95% CI, 37%-53%) in evaluable previously treated patients (n = 149).

Furthermore, the median progression-free survival (PFS) and overall survival (OS) data with tepotinib have matured and look promising, Paik adds. In the overall population, the median PFS was 11.2 months (95% CI, 9.5-13.8), and the median OS was 19.6 months (95% CI, 16.2-22.9). In previously untreated patients, these median values were 12.6 months (95% CI, 9.7-17.7) and 21.3 months (95% CI, 14.2-25.9), respectively. In previously treated patients, these respective median values were 11.0 months (95% CI, 8.2-13.7) and 19.3 (95% CI, 15.6-22.3).

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