About the approval, the studies and the drug, entrectinib –
The first regulatory approval has been granted to entrectinib (Rozlytrek) in Japan for the treatment of adult and pediatric patients with NTRK fusion–positive, advanced recurrent solid tumors.
4 studies – 3 in adult and 1 in pediatric and adolescent patients – using this novel drug, enrolled patients across 15 countries and 150 clinical trial sites. Findings from an integrated analysis of the 3 studies in adults demonstrated a 57.4% response – percentage of patients who experienced disease shrunk or stopped – in patients with NTRK fusion–positive solid tumors and the median duration of response was 10.4 months. Among patients with brain metastases, the response was 50%.
In the studies, tumor types included breast cancer, cholangiocarcinoma, colorectal cancer, gynecological cancer, neuroendocrine tumors, NSCLC, salivary gland cancer, pancreatic cancer, sarcoma and thyroid cancer.
More than 40% of the patients had received ≥2 or more prior lines of therapy, and 37% had untreated cancers.
The dose of entrectinib was set to be 400 mg/m2 daily.
Regarding safety, adverse events (AEs) with entrectinib were consistent with that seen in prior studies. The most commonly reported AEs included fatigue, constipation, dysgeusia, edema, dizziness, diarrhea, nausea, dysesthesia, dyspnea, pain, anemia, cognitive disorders, weight increased, vomiting, cough, blood creatinine increase, arthralgia, pyrexia and myalgia.
The future with entrectinib –
Japanese regulatory authorities are also in the process of reviewing a potential indication for entrectinib for the treatment of patients with ROS1 fusion–positive locally advanced or metastatic non–small cell lung cancer (NSCLC).
Additionally, the pooled findings from the 3 studies on adults showed that entrectinib demonstrated a 77.4% response and a median duration of response of 24.6 months in patients with locally advanced or metastatic ROS1-positive NSCLC.
The FDA is expected to decide on the application for the use in patients with NTRK fusion–positive solid tumors by August 18, 2019.
In the international, multicenter, open-label, ongoing trial, investigators are enrolling 300 patients with solid tumors that harbored an NTRK1-/2-/3-, ROS1- or ALK-positive fusion.
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