NewG Lab "Lung Cancer New Drug, 'Proven to Extend Patient Survival Period More Than Twice Compared to Existing Treatments' Published in International Journal"

[Asia Economy Reporter Hyunseok Yoo] NewgLab announced that ‘Taletrectinib,’ a non-small cell lung cancer treatment drug co-developed with AnHeart Therapeutics in the U.S., demonstrated more than double the progression-free survival (PFS) compared to existing drugs. PFS is an indicator measuring the efficacy of preventing cancer progression.

NewgLab and AnHeart Therapeutics revealed on the 4th that the integrated analysis results of two Phase 1 clinical trials conducted in the U.S. and Japan for Taletrectinib were published in the ‘Journal of Thoracic Oncology (JTO),’ the official journal of the International Association for the Study of Lung Cancer (IASLC).

The clinical results showed a progression-free survival period of 29 months. This is more than twice the efficacy compared to the currently marketed treatment drug ‘Zelboraf,’ which recorded 12 months.

The Phase 1 trials were conducted on 61 patients in the U.S. and Japan. The published paper was based on data measuring ‘progression-free survival’ and ‘objective response rate’ for 18 out of 22 patients with mutated ‘ROS1 non-small cell lung cancer.’

For patients with no prior experience of targeted anticancer drugs, the progression-free survival was 29.1 months. For patients with one prior targeted therapy, it was 14.2 months, and for those with two prior treatments, it was 4.1 months.

Dr. Sai-Hong Ignatius Ou from the University of California, Irvine School of Medicine, who authored the paper, explained, “In the Phase 1 trials conducted in the U.S. and Japan, Taletrectinib confirmed meaningful clinical data and a safety profile for ‘advanced ROS1+ NSCLC patients,’ including those who had never received targeted therapy against the mutated ROS1 protein and those resistant to the only existing treatment, ‘Zelboraf.’”

Hanshin Young, Head of Clinical Development at NewgTherapeutics, said, “Zelboraf, the only competing drug to Taletrectinib, showed a progression-free survival (PFS) of around 12 months, and the median survival time for lung cancer patients who received chemical chemotherapy was only 10 to 12 months. The clinical results announced for Taletrectinib showed very outstanding efficacy, which is an encouraging achievement.”

He added, “NewgTherapeutics plans to start a global Phase 2 clinical trial early next year for Taletrectinib’s ‘ROS1/NTRK’ mutation indications in collaboration with AnHeart.”