Analyzing Asian Patients in VISION Trial: Tepotinib for METex14 Skipping NSCLC

Tepotinib, a tyrosine kinase inhibitor targeting the MET receptor, has been approved for treating non-small cell lung cancer with MET exon 14 skipping mutation in multiple Asian nations. In the VISION clinical trial involving 313 participants with data cut-off on February 20, 2022, tepotinib exhibited sustained clinical efficacy, exhibiting an objective response rate (ORR) of 50.8% and a median duration of response (DOR) of 18.0 months. The intracranial activity of Tepotinib showed promising results in patients diagnosed with brain metastases. Researchers present the findings of researchers study involving 106 Asian patients diagnosed with METex14 skipping non-small cell lung cancer who were enrolled in the VISION program. Patients diagnosed with advanced METex14 missing non-small cell lung cancer, as detected by either liquid biopsy (L+) or tissue biopsy (T+), were administered a daily dose of 500 mg of tepotinib (450 mg active moiety). The study’s primary endpoint is the objective response as per the Response Evaluation Criteria in Solid Tumors version 1.1, determined by the independent review committee. The secondary endpoints comprised disease control (DCR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety (analysis sets: T+, L+, T+, and L+). The study enrolled 106 Asian patients in the VISION trial, with 38 from Japan, 20 from South Korea, 12 from Taiwan, 30 from China, and 6 from outside Asia.

The median age of the patients was 70.5 years, ranging from 52 to 89 years. Of the patients, 39.6% were female, 43.4% had a smoking history, 79.2% had adenocarcinoma, 73.6% had an Eastern Cooperative Oncology Group Performance Status of 1, and 47.2% were treatment-naïve. About 45.3% of the population exhibited L+ characteristics, while 78.3% displayed T+ traits. The objective response rate (ORR) was 57.5%, with a 95% CI of 47.6 to 67.1. The disease control rate (DCR) was 80.2%, with a CI of 71.3 to 87.3. The median duration of response (mDOR) was 18.5 months with a CI of 10.4 to not estimable (ne). The median progression-free survival (mPFS) was 13.8 months, with a CI of 9.6 to 19.9. The median overall survival (mOS) was 23.7 months with a CI of 19.3 to ne. Among the cohort of patients who had not received prior treatment (n=50), the overall response rate (ORR) was 66.0% (with a confidence interval of 51.2 to 78.8). In the group of patients who had received treatment previously (n=56), the ORR was 50.0% (with a confidence interval of 36.3 to 63.7). The significant engagement was noted regardless of the technique employed to identify METex14 skipping (refer to Table). About 95.3% of patients experienced treatment-related adverse events (TRAEs), with 38.7% presenting Grade ≥3 TRAEs. Treatment-related adverse events reduced dosage in 30.2% of patients and permanent discontinuation in 13.2%. The prevailing untoward incidents observed were peripheral edema (65.1%), creatinine elevation (42.5%), and hypoalbuminemia (40.6%). The clinical trial VISION revealed that Tepotinib exhibited resilient and long-lasting effectiveness while maintaining a controllable safety profile among Asian patients diagnosed with METex14 skipping non-small cell lung cancer.

Source:https://oncologypro.esmo.org/meeting-resources/esmo-asia-congress/tepotinib-in-patients-with-met-exon-14-metex14-skipping-nsclc-results-from-all-asian-patients-in-vision

Clinical Trial:https://clinicaltrials.gov/ct2/show/NCT02864992

J.C. Yang, T. Kato, M. Ahn, H. Sakai, M. Morise, Y. Chen, J. Han, J. Yang, J. Zhao, J.L. Huang, K. Berghoff, R. Bruns, H. Vioix, G.P. Otto, X. Le, P.K. Paik/Tepotinib in patients with MET exon 14 (METex14) skipping NSCLC: Results from all Asian patients in VISION/Annals of Oncology (2022) 33 (suppl_9): S1560-S1597. 10.1016/annonc/annonc1134