Dr. Wolf on the Design of GEOMETRY mono-1 Trial in METex14-Mutated NSCLC

Jüergen Wolf, MD, medical director of the Center for Integrated Oncology and professor of Interdisciplinary Translational Oncology at the University Hospital of Cologne, discusses the design and rationale of the phase 2 GEOMETRY mono-1 study with capmatinib (Tabrecta) in METex14-mutated or high MET amplified, advanced non–small cell lung cancer (NSCLC).

The GEOMETRY mono-1 study was a global, multicohort trial evaluating capmatinib in patients with METex14-mutated advanced NSCLC who received prior immunotherapy. The trial systematically evaluated patients according to the line of therapy and molecular driver status, says Wolf. Within the 4 different cohorts, 3 had low and medium amplification with up to a copy number of 9, while the fourth cohort included highly amplified patients, with a copy number of ≥10.

Last year, the initial results were reported on patients with METex14 skipping mutations. Results showed that there was efficacy with the agentin pretreated patients with advanced NSCLC who were receiving treatment in the second- or third-line of therapy, says Wolf. Patients experienced an overall response rate of 39.1% and duration of response was 9.72 months. For this cohort, the primary end point was met because a lower boundary of 35% was assumed. Investigators determined that the trial would be successful if in the pretreatment setting, at least 35% of the patients showed a response. These datacompare favorably with that seen with standard relapsed therapies, concludes Wolf.