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Association details:
Evidence:
Evidence Level:
Sensitive: A1 - Approval
Title:

Apollomics Announces the First Approval of Vebreltinib for MET Exon 14 Skip Non-Small Cell Lung Cancer

Published date:
11/16/2023
Excerpt:
Apollomics...announced that its partner in China, Avistone Biotechnology Co. Ltd., received conditional approval from the National Medical Products Administration (NMPA) of China for the commercialization of vebreltinib to treat patients with MET exon 14 skipping non-small cell lung cancer (NSCLC).
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors

Excerpt:
......
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Clinical trial to evaluate safety and effectiveness of APL-101 for the treatment of advanced c-Met expressing solid tumors, including NSCLC, and to find the best dose Klinikai vizsgálat az APL-101 biztonságosságának és hatásosságának értékelésére előrehaladott c-Met-et expresszáló szolid tumorok, ideértve az NSCLC-t (nem kissejtes tüdőrák), kezelésére és a legmegfelelőbb adagolás megtalálására

Excerpt:
...Cohort A-1: EXON 14 NSCL Cancer – c-Met inhibitor naïve (1L)a.Histologically or cytologically confirmed NSCLC with EXON 14 skip mutations; All histologies (pulmonary sarcomatoid carcinoma and squamous)b.Unresectable or metastatic disease (Stage 3b/4)d.Treatment naïve subjects in first-line e.Not received any c-Met inhibitorCohort A-2: EXON 14 NSCL Cancer – c-Met inhibitor naïve (≥ 2L)a.Histologically or cytologically confirmed NSCLC with EXON 14 skip mutationsb.All histologies, including pulmonary sarcomatoid carcinoma and squamousc.Unresectable or metastatic disease (Stage 3b/4)d.Pretreated subjects refractory to or intolerable to standard therapies with no more than three lines of prior therapye.Not received any c-Met inhibitor4b. ...
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Confirmatory Clinical Study in NSCLC Patients With MET Exon 14 Mutation (KUNPENG-2)

Excerpt:
......
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

1379P - Preliminary results of phase II KUNPENG study of vebreltinib in patients (Pts) with advanced NSCLC harboring c-MET alterations

Published date:
10/16/2023
Excerpt:
...we present data from pts with METex14 mutation (Cohort 1) from a phase II, open-label, multicenter and multi-cohort KUNPENG study of PLB1001 conducted in locally advanced or metastatic NSCLC pts with c-MET alterations....Vebreltinib showed promising efficacy and favorable safety in patients with METex14 mutant NSCLC.
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Abstract CT127: A phase I study of cMET inhibitor bozitinib in patients with advanced NSCLC harboring cMET alterations

Published date:
04/27/2020
Excerpt:
Of the 37 enrolled patients, with a median age of 61: 8 had overexpression; 11 had exon 14 skipping; 8 had amplification and 10 patients had more than 1 type of MET alterations. Bozitinib was generally well-tolerated in all cohorts….ORR for patients with overexpression and amplification (N=6) was 50%. ORR for patients harboring both exon 14 skipping and amplification (N=4) was 100%.
DOI:
10.1158/1538-7445.AM2020-CT127
Trial ID: