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News and reporting on ROS1 biomarkers.
Interim data from the Phase II portion of the study in ROS1-positive non-small cell lung cancer showed an objective response rate of 93 percent.
The biotech will begin clinical trials of its lead drug candidates in ROS1-positive and ALK-positive non-small cell lung cancer in 2021 and 2022, respectively.
The study is evaluating the drug in previously treated NSCLC patients with alterations in EGFR, ALK, ROS1, NTRK, BRAF, MET, or RET.
Baiyunshan will assume responsibility for developing and commercializing HG030 in mainland China, while HitGen will retain rights in all other territories.
The pandemic has underscored the importance of "bringing the trial to the patient," a concept that is likely to persist, particularly in precision oncology.
The drugmaker has had discussion with the FDA about its regulatory plan for repotrectinib based on the efficacy and safety seen in interim analysis.
Entrectinib is authorized for advanced NTRK fusion-positive solid tumors with no alternative treatment, and ROS1-positive NSCLC patients.
The Phase II trial in China will enroll 106 NSCLC patients with ROS1 fusions who have either never received a tyrosine kinase inhibitor or have received Xalkori.
Despite recognition among drugmakers, researchers, and regulators of the need to diversify precision oncology trials, few Black and Hispanic patients are included in studies.
Repotrectinib is an investigational drug intended for the treatment of patients with advanced solid tumors harboring ROS1, NTRK1-3, or ALK molecular rearrangements.