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Tepotinib in patients with NSCLC harbouring MET exon 14 skipping: Japanese subset analysis from the Phase II VISION
Hiroshi Sakai1, Masahiro Morise2, Terufumi Kato3
1Department of Thoracic Oncology, Saitama Cancer Center, Ina, Japan.
Background:
MET exon 14 skipping is an oncogenic driver occurring in 3-4% of non-small cell lung cancer (NSCLC). The MET inhibitor tepotinib has demonstrated clinical efficacy in patients with MET exon 14 skipping NSCLC. Here, we present data from Japanese patients in the Phase II VISION study, evaluating the efficacy and safety of tepotinib.
Methods:
In the open-label, single-arm, Phase II VISION study, patients with advanced/metastatic NSCLC with MET exon 14 skipping received oral tepotinib 500 mg once daily. The primary endpoint was objective response by independent review. Subgroup analyses of Japanese patients were preplanned.
Results:
As of 1 January 2020, 19 Japanese patients received tepotinib and were evaluated for safety, 15 of whom had ≥9 months' follow-up and were also analysed for efficacy. By independent review, objective response rate (ORR) was 60.0% (95% confidence interval [CI]: 32.3, 83.7), median duration of response was not reached (95% CI: 6.9, not estimable [ne]), and progression-free survival was 11.0 months (95% CI: 1.4, ne). ORR in patients with MET exon 14 skipping identified by liquid biopsy (n = 8) was 87.5% (95% CI: 47.3, 99.7), and by tissue biopsy (n = 12) was 50.0% (95% CI: 21.1, 78.9). Patients' quality of life was maintained with tepotinib treatment. Among patients evaluated for safety, the most common treatment-related adverse events (any grade) were blood creatinine increase and peripheral oedema (12 and nine patients, respectively).
Conclusions:
Tepotinib demonstrated robust and durable clinical efficacy in Japanese patients with advanced NSCLC harbouring MET exon 14 skipping, identified by either liquid or tissue biopsy. The main adverse events, blood creatinine increase and peripheral oedema, were manageable.
Insights
Tepotinib showed significant efficacy in Japanese patients with advanced non-small cell lung cancer (NSCLC) driven by MET exon 14 skipping. The treatment was well-tolerated and manageable for patients with this specific NSCLC subtype.
Area of Science:
- Oncology
- Medical Genetics
- Pharmacology
Background:
- MET exon 14 skipping mutations are key oncogenic drivers in 3-4% of non-small cell lung cancer (NSCLC).
- The MET inhibitor tepotinib has shown promise in treating NSCLC patients with MET exon 14 skipping.
- This study focuses on Japanese patients within the Phase II VISION trial, assessing tepotinib's efficacy and safety.
Purpose of the Study:
- To evaluate the efficacy and safety of tepotinib in Japanese patients with advanced/metastatic NSCLC harboring MET exon 14 skipping mutations.
- To analyze objective response rate (ORR), duration of response, and progression-free survival (PFS).
- To assess the impact of tepotinib on patients' quality of life.
Main Methods:
- An open-label, single-arm, Phase II clinical trial (VISION study).
- Japanese patients with advanced/metastatic NSCLC and MET exon 14 skipping received oral tepotinib 500 mg daily.
- Primary endpoint: objective response by independent review; subgroup analyses for Japanese patients were preplanned.
Main Results:
- Objective response rate (ORR) was 60.0% in 15 evaluable Japanese patients.
- ORR was higher in patients identified by liquid biopsy (87.5%) compared to tissue biopsy (50.0%).
- Median duration of response and PFS were not reached; quality of life was maintained. Common adverse events included blood creatinine increase and peripheral edema.
Conclusions:
- Tepotinib demonstrates robust and durable efficacy in Japanese patients with advanced NSCLC harboring MET exon 14 skipping.
- The efficacy was observed regardless of whether the mutation was identified by liquid or tissue biopsy.
- Adverse events associated with tepotinib were manageable.
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