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VISION showed that a once-daily MET tablet shrank about half of advanced lung cancers driven by a MET exon 14 skipping mutation, whether the mutation was found in blood or in tumour tissue, which led to tepotinib's approvals in Japan, the United States and Europe.
VISION (NCT02864992; sponsor code MS200095-0022) is an open-label, single-arm phase 2 study of tepotinib 500 mg once daily in advanced non-small-cell lung cancer with MET exon 14 skipping, detected in circulating tumour DNA, tumour tissue or both, with a later cohort in MET amplification. The primary endpoint was objective response by independent review among patients followed for at least nine months.
In the NEJM 2020 primary analysis (Paik and colleagues), 152 patients had received tepotinib by 1 January 2020 and 99 had at least nine months of follow-up. The independent-review response rate in the combined-biopsy group was 46 percent (95 percent CI 36 to 57), with a median duration of response of 11.1 months (95 percent CI 7.2 to not estimable). Response rates were 48 percent among 66 patients in the liquid-biopsy group and 50 percent among 60 in the tissue-biopsy group; 27 patients were positive by both. The investigator-assessed response rate was 56 percent and did not depend on previous treatment for advanced disease. Grade 3 or higher treatment-related adverse events occurred in 28 percent, including peripheral oedema in 7 percent, and adverse events led to permanent discontinuation in 11 percent. A molecular response in circulating free DNA was seen in 67 percent of patients with matched samples.
Japan approved tepotinib in 2020, the United States in 2021 (with full approval in 2024) and the EU in 2022. The registry lists 337 participants across all cohorts and the study as active, not recruiting, with completion expected in August 2026. Capmatinib (GEOMETRY mono-1) is the other approved MET exon 14 inhibitor; the Pluvicto prostate-cancer trial also named VISION is a different study (id vision, NCT03511664).
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
337 enrolled.
95% CI 36 to 57; 152 patients had received tepotinib by the 1 January 2020 cutoff
Source95% CI 7.2 to not estimable
Source95% CI 36 to 61
Source95% CI 37 to 63
SourcePeripheral oedema 7%; adverse events led to permanent discontinuation in 11%
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Objective response rate by independent review, combined-biopsy group (at least 9 months of follow-up)primary | Tepotinib 500 mg daily | 99 | 46% | - | - | link |
| Median duration of response by independent review, combined-biopsy group | Tepotinib 500 mg daily | 99 | 11.1 months | - | - | link |
| Objective response rate by independent review, liquid-biopsy group | Tepotinib 500 mg daily | 66 | 48% | - | - | link |
| Objective response rate by independent review, tissue-biopsy group | Tepotinib 500 mg daily | 60 | 50% | - | - | link |
| Grade 3 or higher treatment-related adverse events | Tepotinib 500 mg daily | 152 | 28% | - | - | link |
A second publication from the trial, later than the first and described in its title as an update or longer-term analysis. Read it with the primary publication linked from the trial page; the record was linked automatically and its figures have not been checked by hand.
Tepotinib is an approved alternative to capmatinib for MET exon 14 lung cancer, and the trial validated circulating tumour DNA as a way to find the alteration.
Shares MET exon 14 and MET-amplified non-small-cell lung cancer, MET, Non-small-cell lung cancer and the tag pipeline.
Shares MET exon 14 and MET-amplified non-small-cell lung cancer, Small-molecule kinase inhibitors, Non-small-cell lung cancer and the tag pipeline.
Shares MET exon 14 and MET-amplified non-small-cell lung cancer, Small-molecule kinase inhibitors, Non-small-cell lung cancer and the tag pipeline.
Shares MET exon 14 and MET-amplified non-small-cell lung cancer, Small-molecule kinase inhibitors, Non-small-cell lung cancer and the tag pipeline.
Shares MET exon 14 and MET-amplified non-small-cell lung cancer, Non-small-cell lung cancer and the tag pipeline.
Shares MET exon 14 and MET-amplified non-small-cell lung cancer, Small-molecule kinase inhibitors, Non-small-cell lung cancer and the tag pipeline.
Shares MET, Small-molecule kinase inhibitors, Non-small-cell lung cancer and the tag pipeline.
Shares MET exon 14 and MET-amplified non-small-cell lung cancer, Small-molecule kinase inhibitors, Non-small-cell lung cancer and the tag pipeline.