Bayer’s Vitrakvi (larotrectinib) had a 71% response rate in a subgroup of patients with non-small cell lung cancer (NSCLC) with neurotrophic receptor tyrosine kinase (NTRK) gene fusion.
Vitrakvi is the only TRK inhibitor exclusively designed for the treatment of adult and pediatric patients with solid tumors that have an NTRK gene fusion without a known acquired resistance mutation that are either metastatic or where surgical resection will likely result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment, according to Bayer.
The analysis assessed 11 advanced metastatic NSCLC patients from two clinical studies, of which seven were evaluable for response.
This subset showed an overall response rate (ORR) of 71%, including one complete response and four partial responses, based on investigator assessment using RECIST version 1.1.
Data were presented at the European Lung Cancer Congress, taking place in Geneva, Switzerland, from April 10-13, 2019.
In the US, Vitrakvi was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
“The efficacy and safety of larotrectinib in patients with NSCLC reinforce the importance of identifying genomic alterations early,” said Alexander Drilon, MD, clinical director of Early Drug Development Service at Memorial Sloan Kettering Cancer Center. “Lung cancer is the leading cause of cancer deaths in the United States and these data are important to progressing the treatment options available for these patients in order to provide appropriate care.”