NEW YORK – Turning Point Therapeutics said this week that it has reached the enrollment goal for an expansion cohort in its Phase I/II registrational TRIDENT-1 study evaluating its ROS1, TRK, and ALK inhibitor repotrectinib. The expansion cohort includes 40 previously treated patients with NTRK-positive advanced solid tumors. With this cohort fully enrolled, Turning Point expects to begin discussions with the US Food and Drug Administration in Q1 2023 to determine the registration timeline for repotrectinib in NTRK-positive advanced solid tumor patients. Additionally, Turning Point expects to report top-line data from its trial exploring repotrectinib in ROS1-positive non-small cell lung cancer patients and to begin discussions with the FDA for this indication in Q2 2022.
NGeneBio said this week that it has submitted an application to Korea's Ministry of Food and Drug Safety for Class III in vitro diagnostic medical device approval of its next-generation sequencing test OncoAccuPanel. NGeneBio developed the panel — which can detect microsatellite instability status, tumor mutational burden, and more than 300 cancer-associated genes — in collaboration with the Seoul Asan Medical Center and the Dana-Farber Cancer Institute. The firm is also preparing the OncoAccuPanel for CE-IVD marking in Europe.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Oncology News.