Taletrectinib May Show Promise in ROS1+ Non–Small Cell Lung Cancer


Patients with ROS1-positive non–small cell lung cancer may derive benefit from being treated with ROS1/NTRK inhibitor taletrectinib.

Taletrectinib (AB-106) demonstrated promising interim results in patients with ROS1-positive non–small cell lung cancer (NSCLC), according to data from the phase 2 TRUST trial (NCT04395677) that were presented at the 2021 Chinese Society of Clinical Oncology Annual Meeting.

Patients who were part of the crizotinib (Xalkori)-naïve group (n = 21) experienced a confirmed overall response rate (ORR) of 90.5%, as well as a disease control rate (DCR) of 90.5%. Among those who had been previous treated with crizotinib (n = 16), investigators reported a confirmed ORR of 43.8% and a DCR of 75.0%.

“We are pleased with the interim phase 2 data, which have shown taletrectinib to be safe and tolerable, a very promising novel therapy for patients with ROS1 fusion positive lung cancer. Responses appear particularly impressive in crizotinib treatment-naïve patients, and while the number of crizotinib pre-treated patients is limited, so far, most patients continue to show benefit from the drug,” Caicun Zhou, MD, PhD, director of the Department of Oncology at Shanghai Pulmonary Hospital, said in a press release.

The investigational next-generation Tyrosine kinase inhibitor (TKI) can target both ROS1 and NTRK fusion mutations, as well as having potential in patients who are TKI naïve or pretreated.

Patients who enrolled on the study received 400 mg of taletrectinib once daily in stage 1, although 3 patients were treated with 600 mg. In stage 2, all patients were treated with 600 mg.

The primary outcome was best ORR, with key secondary outcomes including duration of response, time to response, time to progression, progression-free survival, intracranial best ORR, duration of intracranial response, and overall survival.

Patients who enrolled needed to be 18 years of age or older with histologically or cytologically confirmed, locally advanced or metastatic NSCLC with a ROS1 fusion. Additionally, patients were required to either be TKI-naïve or experience disease progression after being treated with crizotinib. Any previous treatment with chemotherapy and radiation therapy needed to be completed 2 weeks prior to enrolling on the study. Additionally, an ECOG performance status of 0 or 1 was required.

Patients who were actively participating in another therapeutic investigational study, were previously enrolled on a trial utilizing ROS1 TKIs aside from crizotinib, or who previously were treated with an ALK– or NTRK fusion targeted–therapy were not eligible to enroll on the trial.

Additional findings from the trial indicated that among patients in the pretreated cohort, all 3 patients with ROS1 G2032R resistant mutations experienced tumor regression; moreover, 2 patients experienced a partial response and 1 achieved stable disease. Patients with assessable brain metastases prior to enrollment achieved an intracranial ORR by investigator assessment of 83.3%.

“Our team is focused on completing patient enrollment for our phase 2 TRUST trial. The interim data presented builds a strong foundation for our ongoing global pivotal taletrectinib clinical program. We sincerely thank the patients, their families and investigators in the TRUST trial and look forward to advancing development of taletrectinib for all ROS1 fusion positive patients with NSCLC, an area of significant unmet medical needs,” Bing Yan, MD, co-founder and chief medical officer of AnHeart Therapeutics, concluded.


Innovent and AnHeart announce interim data from phase 2 trial of taletrectinib in ROS1-positive NSCLC at the CSCO 2021 Annual Meeting. News release. Innovent Biologics. September 26, 2021. Accessed September 27, 2021. https://prn.to/3EUycWy

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