Despite three rivals on the US market, the next-generation ROS1 TKI could become the preferred treatment option for ROS1-positive disease.
Compared with crizotinib and entrectinib, Nuvation Bio data suggests taletrectinib has greater brain penetration, lower incidence of neurologic adverse events, less likelihood of resistance, and other benefits, plus a possible safety and efficacy edge over next-generation rival repotrectinib.
“Taletrectinib will likely become the preferred treatment option for advanced ROS1+ NSCLC,” commented Thomas E. Stinchcombe, MD, an associate editor at thegene, which leads to an abnormal ROS1 fusion protein that drives cancer growth. ROS1 TKIs block the protein’s activity. The drug’s approval was based on results of TRUST-I and TRUST-II, phase 2, single-arm, open label studies in ROS1-positive NSCLC patients treated with oral taletrectinib 600 mg once daily until progression, unacceptable toxicity, death, or consent withdrawal. Of the 273 subjects in the pooled analysis, 93.8% had stage IV disease, 33.7% had brain metastases, and 27.1% had received chemotherapy.The efficacy population included 157 patients who were naive to treatment with a ROS1 TKI and 113 patients who had received one prior ROS1 TKI. Patients may have received prior chemotherapy for advanced disease. For treatment-naive patients, the overall response rate was 90% in TRUST-I and 85% in TRUST-II, with 72% and 63% of responders having a duration of response of at least a year, respectively. For TKI-pretreated patients, ORR was 52% in TRUST-I and 62% in TRUST-II, with 74% and 83% of responders having a DOR of at least 6 months, respectively. Among 13 patients with a G2032R mutation, which triggers resistance to first generation ROS1 TKIs, eight had a response to taletrectinib. In a safety analysis with 352 patients, the most frequent treatment-emergent adverse events with taletrectinib were gastrointestinal problems and elevated aspartate aminotransferase and alanine aminotransferase . Neurologic adverse events included dizziness and dysgeusia . Overall, 33% of patients had grade 3 or higher treatment-related adverse events. Treatment-emergent adverse events led to discontinuation in 7% of patients. There were three treatment-related deaths due to abnormal hepatic function, liver failure, and pneumonia. The recommended taletrectinib dose is 600 mg orally once daily on an empty stomach until disease progression or unacceptable toxicity.M. Alexander Otto is a physician assistant with a master’s degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape. Alex is also an MIT Knight Science Journalism fellow. Email:All material on this website is protected by copyright, Copyright © 1994-2025 by WebMD LLC. This website also contains material copyrighted by 3rd parties.
Lung Carcinoma Cancer Of The Lung Non-Small Cell Lung Cancer NSCLC Non-Small Cell Lung Cancer (NSCLC) Otolaryngology ENT Specialty ENT Speciality Brain Metastasis Metastatic Brain Tumor Metastatic Disease To The Brain Brain Metastases Metastatic Brain Tumour Dentistry Oral Health Oral Medicine Dental Health Dental Oral Healthcare Oral Health Care
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