Neoadjuvant and adjuvant capmatinib in resectable non–small cell lung cancer with MET exon 14 skipping mutation or high MET amplification: GEOMETRY-N trial.

• DOI: 10.1200/jco.2022.40.16_suppl.tps8590
• Publication Date: 2022-06-06T17:17:10Z
• Authors: Jay M. Lee; Mark M. Awad; Teddy Rassem Saliba; Nydia Caro; Hiya Banerjee; Karen Kelly
• Keywords: Neoadjuvant Therapy; Targeted Therapy; Adjuvant Therapy

TPS8590 Background: Neoadjuvant therapy is the earliest opportunity to eliminate micrometastatic disease. Emerging data suggest that neoadjuvant in non-small cell lung cancer (NSCLC) can elicit major pathological responses (MPRs) translate into prolonged survival outcomes, serving as an early surrogate for efficacy. Adjuvant improve overall and disease-free (DFS) patients with completely resected NSCLC. DFS observed osimertinib early-stage EGFR-mutated tumors supports evaluation of other tyrosine kinase inhibitors (TKIs) adjuvant settings. In NSCLC, MET exon 14 skipping mutation ( METex14) de novo amplification METamp) are estimated occur up 2.8% 1.7% patients, respectively. Capmatinib, a selective TKI, FDA approved metastatic METex14 It was studied GEOMETRY mono-1 advanced/metastatic NSCLC or METamp. 2 treatment-naive cohorts, response rate (ORR) 68% 66%. high-level METamp cohort, ORR 40%. Capmatinib had tolerable safety profile; most adverse events were reversible dose adjustments. Based on ORRs profile MET-dysregulated GEOMETRY-N (NCT04926831), Phase II, 2-cohort, 2-stage study, evaluating efficacy capmatinib improving MPR outcomes Methods: Adults resectable, histologically confirmed stage IB-IIIA, N2 select IIIB (T3N2 T4N2) either (cohort A) (gene copy number ≥10; cohort B) eligible. must be determined by Clinical Laboratory Improvement Amendments (CLIA)-certified lab. fluorescence situ hybridization at CLIA-certified lab FoundationOne CDx next-generation sequencing. Prior systemic anticancer prohibited. Patients will receive 400 mg twice daily 8 weeks before surgical resection, followed 3 years capmatinib. design, 1 enroll 9 per evaluated each after have completed therapy; 2, enrolling 10 more proceed only if ≥1 participants has MPR. About 42 enrolled, 19 evaluable cohort. Primary endpoint (local assessment). Secondary endpoints complete (central local review), assessment), DFS, safety. Following treatment, there 2-year follow-up. Enrollment started; expected first patient visit: March 31, 2022. trial information: NCT04926831.