NTRK Fusion–Positive Solid Tumors: Entrectinib Granted Conditional Marketing Authorization in the European Union
Posted: Wednesday, August 4, 2021
According to research presented in ESMO Open Cancer Horizons, the NTRK inhibitor entrectinib may be a well-tolerated and efficacious treatment for some patients with non–small cell lung cancer who have NTRK fusion–positive solid tumors. Julio Delgado, MD, PhD, of the European Medicines Agency in Amsterdam, and colleagues evaluated the results of multiple studies that had contributed to the European Union’s issuing of a conditional marketing authorization for entrectinib use in a specific patient population.
“On 31 July 2020, a conditional marketing authorization valid through the European Union (EU) was issued for entrectinib for the treatment of adult and pediatric patients 12 years of age and older with NTRK fusion–positive solid tumors that are locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor and have no satisfactory therapy,” noted the study authors.
The summary report included 74 adults across 2 phase I studies (ALKA and STARTRK-1) and 1 phase II study (STARTRK-2) who had received at least 600 mg of entrectinib in 1 or more doses, were NTRK inhibitor therapy–naive, and had extracranial tumors. At a median follow-up of 14.2 months, the objective response rate was 63.5%, with a median duration of response of 12.9 months. Median progression-free survival was 11.2 months, and, though results were immature, median overall survival was 23.9 months.
Safety data across all three trials plus an additional pediatric trial (STARTRK-NG) indicated that 99.4% of patients experienced at least a single treatment-related adverse event. Dysgeusia (41.1%), fatigue (27.9%), dizziness (25.4%), constipation (23.7%), and diarrhea (22.8%) were among the most frequently reported treatment-related adverse events. A total of 61.1% of patients experienced adverse events of at least grade 3, and 9.1% discontinued treatment as a result of adverse events.
Disclosure: The study authors reported no conflicts of interest.