Originally published by our sister publication Clinical Oncology News
By Clinical Oncology News Staff
The FDA approved taletrectinib (Ibtrozi, Nuvation Bio), a kinase inhibitor, for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
Efficacy was evaluated in patients with locally advanced or metastatic, ROS1-positive NSCLC enrolled in two multicenter, single-arm, open-label clinical trials: TRUST-I (ClinicalTrials.gov Identifier: NCT04395677) and TRUST-II (NCT04919811). The efficacy population included 157 patients (103 in TRUST-I; 54 in TRUST-II) who were naive to treatment with a ROS1 tyrosine kinase inhibitor (TKI) and 113 patients (66 in TRUST-I; 47 in TRUST-II) who had received one prior ROS1 TKI. Patients were allowed to have received prior chemotherapy for advanced disease.
The major efficacy outcome measures were confirmed overall response rate (ORR) and duration of response (DOR), determined by blinded independent central review according to RECIST v1.1.
For treatment-naive patients, the ORR was 90% (95% CI, 83%-95%) in TRUST-I and 85% (95% CI, 73%-93%) in TRUST-II, with 72% and 63% of responders having a DOR of 12 months or more, respectively. For TKI-pretreated patients, the ORR was 52% (95% CI, 39%-64%) in TRUST-I and 62% (95% CI, 46%-75) in TRUST-II, with 74% and 83% of responders having a DOR of six months or more, respectively.
The prescribing information for taletrectinib includes warnings and precautions for hepatotoxicity, interstitial lung disease/pneumonitis, QTc interval prolongation, hyperuricemia, myalgia with creatine phosphokinase elevation, skeletal fractures and embryo-fetal toxicity.
The full prescribing information for Ibtrozi will be posted on Drugs@FDA.
Based on a press release from the FDA.