First, the drug company Roche for the treatment of malignant tumors regardless of their location approved in Europe for use in patients with solid tumors with NTRK translocations and patients with ROS1-positive metastatic non-small cell lung cancer. Thanks to the approval of the drug appeared to affect the specific genetic drivers of disease, regardless of the location of the tumor in the body, told in the company.
The decision on registration of the drug entretenir made on the basis of the results of the combined analysis of data of clinical phase II study STARTRK-2, studies of phase I of STARTRK-1 and ALKA-372-001, as well as studies I/II phase STARTRK-NG. Studies have shown that the use of the drug entretenir allows to achieve stable response in various types of solid tumors with translocations NTRK, including sarcoma, non-small cell lung cancer, secretory carcinoma of the salivary gland, secretory and nesekretnye breast carcinoma, thyroid cancer, colon cancer, neuroendocrine tumor, pancreatic tumor, ovarian cancer, carcinoma of the endometrium, cholangiocarcinoma, tumors of the gastrointestinal tract and neuroblastoma and non-small cell lung cancer with the ROS1 gene rearrangements.
Studies have shown that treatment with entractinon reduced the tumor volume by more than half of the patients with locally advanced or metastatic solid tumors with translocations NTRK, objective responses were observed in 14 tumors (median duration of response of 12.9). While ROS1-positive metastatic non-small cell lung cancer as a result of application of intretinere tumor volume decreased from 73,4% of patients, with a median duration of response of 16.5 months.
Objective response during therapy with entractinon observed in patients with metastases in the Central nervous system, with intracranial response rates of 62.5% and 79.2% among patients with NTRK – and ROS1-positive tumors, respectively.
The result of the application of intretinere tumor volume decreased in all patients children and adolescents with tumors with rearrangements of the gene NTRK (N=5), while two of them achieved complete response. Two patients with primary malignant tumors of the Central nervous system were obtained objective responses, including complete response in one patient.