Uterine Sarcoma: Useful In Certain Circumstances…Larotrectinib or entrectinib for NTRK gene fusion-positive tumors...

ROZLYTREK is a kinase inhibitor indicated for the treatment of...Adult and pediatric patients older than 1 month of age with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation.

After a median follow-up of 17.74 months (95% CI 9.95–22.57), the confirmed ORR was 56.3% (95% CI 29.9–80.3...The majority of patients with sarcoma experienced a reduction in tumour lesion size, including those with CNS metastases at baseline...Entrectinib continued to achieve clinically meaningful, durable responses, demonstrating overall efficacy in patients with NTRK fusion-positive sarcoma.

In total, 20 pts with ROS1-fp NSCLC and 10 pts with NTRK-fp solid tumours (5 salivary, 1 breast, 1 colorectal, 1 NSCLC, 1 sarcoma, 1 thyroid) were efficacy evaluable. For both cohorts, median survival follow-up was 38.6 mos and ORR was 70%....The 24-mos OS rates were 65% (ROS1-fp NSCLC) and 90% (NTRK-fp solid tumours). In pts without baseline CNS mets by investigator, ORR was 76% (ROS1-fp NSCLC; n=13/17) and 75% (NTRK-fp solid tumours; n=6/8). In pts with baseline CNS mets by BICR (3 ROS1-fp; 1 NTRK-fp), one pt (NTRK-fp) had an IC response....Entrectinib showed deep and durable responses and manageable safety in Japanese pts with locally advanced/metastatic ROS1-fp NSCLC or NTRK-fp solid tumours.