Nuvation Bio’s Ibtrozi (taletrectinib) was just approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). The recommended dose is 600 mg, taken orally, once daily on an empty stomach (no food intake before or after ingestion for two hours).
The drug’s efficacy was measured in two clinical trials: TRUST-I and TRUST-II. From the trials, the overall response rate was 90% for treatment-naive patients in TRUST-I, 85% in TRUST-II. Of those patients, their duration of response was a year or more in 72% and 63% of patients for TRUST-I and TRUST-II, respectively.
Patients who previously received ROS1 tyrosine kinase inhibitor treatment were also included in the study, for comparison. These patients’ overall response rates were slightly lower: 52% and 62% for TRUST-I and TRUST-II, respectively. A six month or greater duration of response was recorded in 74% in patients who received prior treatment in the TRUST-I trial, and 83% in TRUST-II.
Prescribing information provides warnings and precautions for embryo-fetal toxicity, hepatotoxicity, hyperuricemia, interstitial lung disease/pneumonitis, myalgia with creatine phosphokinase elevation, QTc interval prolongation, and skeletal fractures.
Guidelines Related To This Topic:
- Management of Stage III Non-small Cell Lung Cancer
- American Society of Clinical Oncology
- Therapy for Stage IV Non-small Cell Lung Cancer with Driver Alterations
- American Society of Clinical Oncology
- Treatment of Stage III Non-small Cell Lung Cancer
- American College of Chest Physicians
- Treatment of Stage IV Non-small Cell Lung Cancer
- American College of Chest Physicians
- Multidisciplinary Management and Resectability of Locally Advanced Non-small Cell Lung Cancer
- Society of Thoracic Surgeons
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