NewgLab Pharma Completes First Patient Enrollment in Phase 2 Clinical Trial for Lung Cancer Treatment

[Asia Economy Reporter Yoo Hyun-seok] NewG Lab Pharma announced on the 29th that its new drug development subsidiary, NewG Lab Therapeutics (formerly NewGen Therapeutics), has completed the first patient enrollment for the domestic Phase 2 clinical trial of the non-small cell lung cancer treatment drug "Taletrectinib" and is officially starting the clinical trial.

Among domestic clinical institutions, Seoul Asan Medical Center was the first to begin patient enrollment, and sequential patient enrollment will be conducted at four major hospitals including Korea University Medical Center, Pusan National University Hospital, and Hwasun Chonnam National University Hospital.

Taletrectinib is an innovative next-generation targeted anticancer drug that has already demonstrated complete remission cases and the ability to cross the blood-brain barrier in global Phase 1 clinical trials.

Currently, global Phase 2 clinical trials are being conducted simultaneously in South Korea, the United States, Japan, and China. This drug blocks and inhibits the activity of 'ROS1' and 'tyrosine receptor kinase (NTRK) gene fusion variant proteins' found in various solid tumors including non-small cell lung cancer, preventing cancer metastasis and eliminating tumors.

The domestic clinical trial plans to focus on patients with non-small cell lung cancer ROS-1 mutations who have taken the standard ROS1 mutation treatment drug "Xalkori" (active ingredient crizotinib) by Pfizer, as well as patients who have developed resistance to the approved targeted anticancer drug.

Innovent Biologics, which has been conducting clinical trials in China, recently announced at the Chinese Society of Clinical Oncology (CSCO) that the objective response rate (ORR, the proportion of patients showing tumor size reduction among all patients) of Taletrectinib was 90.5% in the treatment-naive patient group, significantly surpassing the ORR of 72% of the competing drug "Xalkori" at the time of FDA approval in the United States.

Additionally, the ORR in the "Xalkori-resistant patient group" was confirmed to be 43.8%, which is a figure that proves Taletrectinib can be the only treatment option for patients resistant to Xalkori who previously had no treatment options.

A representative of NewG Lab Therapeutics said, "Since positive data on the efficacy of Taletrectinib has been confirmed in China, we are confident in the successful progress of the clinical trial domestically. We will strive to rapidly commercialize through conditional use procedures and segment Taletrectinib by region and patient to quickly capture the global non-small cell lung cancer treatment market."

This content was produced with the assistance of AI translation services.