Phase 2 Trial Results Demonstrate Taletrectinib Decreased Tumor Sizes in Patients with NSCLC


Not only did taletrectinib shrink tumors in 92% of patients who were tyrosine kinase inhibitor -naïve, but 89.5% of patients continued to respond to treatment at 12 months.

Results from the pivotal phase 2 clinical trial, TRUST-II (NCT04919811), demonstrate that the oral ROS1 inhibitor taletrectinib (IBI-344/AB-106; Innovent Biologics and AnHeart Therapeutics) had shrank tumors in patients with advanced ROS1-positve non-small cell lung cancer (NSCLC) who had previously been treated with a ROS1 tyrosine kinase inhibitor (TKI). In addition, taletrectinib had presented intracranial activity in the subgroup of patients with disease that had spread to the brain.

X-ray image of lungs with tumor

Image credit: SciePro |

“While people with other types of lung cancer have seen great advances, there has been limited progress for people with ROS1-positive NSCLC, which presents significant treatment challenges,” said TRUST-II trial investigator Maurice Pérol, MD, head of thoracic oncology at Léon Bérard Cancer Center, Lyon, France, in a press release.

TRUST-II is a global, pivotal, multicenter, single-arm, open-label phase 2 clinical trial that evaluated taletrectinib as a monotherapy in 154 patients with ROS1-postive NSCLC and other solid tumors. Patients were split into 4 cohorts: cohort 1 included patients with ROS1-positive NSCLC who were not previously treated with a ROS1 TKI (n = 53), cohort 2 included patients with ROS1-positive NSCLC previously treated with a ROS1 TKI (crizotinib or entrectinib; n = 46), cohort 3 included patients with ROS1-positive NSCLC who were either previously been treated with 2 or more ROS1 TKIs (n = 35), and cohort 4 (patients ineligible for the other 3 cohorts (n = 20). In all cohorts, patients received 600 mg of taletrectinib daily.

The results demonstrated that in ROS1 naïve patients, 92% of tumors shrank in response to taletrectinib treatment and at 12 months, 89.5% of patients who responded to treatment continued to respond. In patients who were previously treated with 1 ROS1 TKI, 57.1% of patients’ tumors shrank in response to taletrectinib treatment, and at 12 months, 81.5% of patients who responded to treatment continued to see results. In patients whose cancer had spread to the brain, taletrectinib shrank brain tumors in 80% in cohort 1 and 62.5% in cohort 2. In addition, the median progression-free survival for patients who were pre-treated with a TKI was 11.7 months.

“We now have consistent results from two phase 2 trials with taletrectinib. In both trials, taletrectinib shrank tumors in almost every ROS1 TKI naïve person and more than half of people previously treated with a ROS1 TKI, and the responses were durable. Taletrectinib was well tolerated, which is extremely important as we work to extend the time people with advanced ROS1-positive NSCLC live without their disease getting worse,” Jerry Wang, PhD, chief executive officer of AnHeart, said in a press release.

The most common treatment emergent adverse events (TEAEs) were grade 1 or 2 and consisted of increased liver enzymes (alanine aminotransferase, 64%; aspartate aminotransferase, 63%) and gastrointestinal-related complications, such as diarrhea (43%) and nausea (43%). Neurological TEAEs were low, with the most common being dizziness in 13% of patients treated with taletrectinib.

“These interim TRUST-II data represent a significant step forward in the pursuit of better treatment options,” said Pérol in the press release. “Taletrectinib’s overall profile suggests it has the potential to be the medicine people with ROS1-positive NSCLC have been waiting for.”


AnHeart Therapeutics’ Investigational Medicine Taletrectinib Shrank Tumors in More Than 90 Percent of People with ROS1-Positive Non-Small Cell Lung Cancer who were ROS1 TKI Naïve in Global Pivotal TRUST-II Trial. News release. AnHeart Therapeutics. October 21, 2023. Accessed October 23, 2023.

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