David S. Hong, MD, discusses updated findings from an analysis of 3 trials which ultimately led to the approval of larotrectinib for patients with solid tumors who harbor an NTRK fusion.
David S. Hong, MD, deputy chair, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, discusses updated findings from an analysis of 3 trials which ultimately led to the approval of larotrectinib (Vitrakvi) for patients with solid tumors that harbor an NTRK fusion.
These studies include the phase 2 NAVIGATE (NCT02576431), phase 1 LOXO-TRK-14001 (NCT02122913), and phase 1/2 SCOUT (NCT02637687) trials which each evaluated larotrectinib as an NTRK inhibitor.
Looking at each trial, SCOUT, NAVIGATE, and LOXO-TRK-14001, Hong notes that larotrectinib continues to show robust and durable objective responses when used to treat patients with TRK fusions. The agent also demonstrated to have a favorable long-term safety profile in the analysis.
0:08 | In this most recent analysis, we looked at close to 244 patients. In those 244 patients, we looked at response rates, progression-free survival, duration of response, and overall survival. It's always amazing to me when I see this updated data, how durable and how beneficial this drug is in these patients. The overall response rate remained very high, close to 70%, 69%, with complete response rates of over 21%. The median duration of response was 32.9 months, with median progression-free survival at 29.4 months, and the overall survival had yet to be reached across all different pathologies.
1:18 | The overall safety signal, including in the phase 1 trial and all the other studies of about 269 patients, the vast majority of adverse events had only been grades 1 and 2. About 20% of the patients had grade 3 treatment related adverse events, mostly related to elevated liver function tests, which were usually reversible once the drugs were held, and dose reduced. This was pretty much the same thing that we saw with larotrectinib with the initial approval at 55 patients.
2:00 | In this expanded analysis, larotrectinib continued to show robust and durable objective responses in patients with TRK fusions and a favorable long-term safety profile. It speaks to the fact that with next generation sequencing [NGS] being a common test that we can get in our patients, it behooves every oncologist to try to find these patients through NGS testing.