[Asia Economy Reporter Jang Hyowon] NewGene Lab Pharma announced on the 15th that the interim data from the Phase 2 clinical trial of Taletrectinib, conducted in China by Innovent Biologics and AnHeart Therapeutics in the United States, has been positively confirmed. The interim results were presented as a keynote speech at the China Society of Clinical Oncology Annual Meeting (CSCO 2021).
Taletrectinib is a targeted anticancer drug aimed at ROS1 and NTRK fusion mutations. The Chinese clinical trial subjects included 21 ROS1-positive non-small cell lung cancer patients who had no prior treatment with Xalkori (generic name Crizotinib) and 16 patients who had received Xalkori treatment.
The interim analysis showed a confirmed objective response rate (ORR) of 90.5% (19/21) and a disease control rate (DCR) of 90.5% (19/21) in the treatment-naive patient group. In the group that had received Xalkori treatment, the confirmed ORR was 43.8% (7/16), and the DCR was 75.0% (12/16). Among patients with brain metastases, the intracranial objective response rate (investigator-assessed) was 83.3% (5/6).
Notably, compared to the 72% objective response rate for ROS-1 when the competing drug Xalkori was approved by the FDA in 2016, these figures demonstrate the superior tolerability of Taletrectinib.
A NewGene Lab Pharma official stated, “Taletrectinib has previously shown a complete remission case where the cancer completely disappeared in preclinical and Phase 1 clinical trials, as well as the ability to cross the blood-brain barrier (BBB) and suppress metastatic brain tumors. Since the interim results from the Chinese clinical trial have already shown efficacy data exceeding expectations, we anticipate positive clinical outcomes.”
He added, “Especially, the interim results from the Chinese Phase 2 clinical trial raise expectations for positive results in the domestic Phase 2 trial as well. We will do our best to ensure that the domestic Phase 2 clinical trial of Taletrectinib can quickly achieve successful results based on the clinical trial data from China.”
Meanwhile, the China Society of Clinical Oncology (CSCO) is the most prestigious oncology society in China. In 2021, a total of 33 guidelines (23 updates and 10 new presentations) were announced, providing clinical guidelines for cancer treatment within China.
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