NewgLab Pharma Changes Lung Cancer Treatment to First-Line Therapy... 'Complete Remission and Brain Metastasis Suppression'

[Asia Economy Reporter Hyungsoo Park] NewgLab Pharma announced on the 2nd that its new drug development subsidiary, NewgLab Therapeutics, has received approval from the Ministry of Food and Drug Safety (MFDS) to expand the clinical trial target of the non-small cell lung cancer treatment drug 'Taletrectinib,' currently undergoing Phase 2 clinical trials in Korea, to include 'treatment-naive ROS-1 mutation new lung cancer patients.'

NewgLab Therapeutics received approval from the MFDS for Phase 2 clinical trials of Taletrectinib in Korea last September. Currently, clinical trials are being conducted at Seoul Asan Medical Center and other institutions targeting patients who developed resistance while using Pfizer's 'Xalkori,' known as the standard treatment for lung cancer.

With the approval of the clinical trial modification, Taletrectinib can now be tested on all lung cancer patients in Korea. This not only significantly shortens the clinical trial period but also greatly expands the drug's market potential.

Taletrectinib, which is undergoing global clinical trials in countries including Korea, the United States, Japan, and China, recently disclosed at the 'Chinese Society of Clinical Oncology Annual Meeting (CSCO 2021)' that in treatment-naive patient groups (N=21), it achieved an objective response rate (ORR) of 90.5% and a disease control rate (DCR) of 95%. This confirmed excellent efficacy in new lung cancer patients.

In the patient group treated with Xalkori (n=16), the objective response rate was 43.8% (7/16), and the disease control rate was 75.0% (12/16). Currently, there is no drug available worldwide for patients who have developed resistance to Xalkori, the standard treatment for non-small cell lung cancer. Based on clinical trial results, Taletrectinib is expected to be an excellent alternative for Xalkori-resistant patients.

Taletrectinib attracted industry attention by demonstrating complete remission and brain metastasis suppression effects in Phase 1 clinical trials conducted in the United States and Japan.

A NewgLab Pharma official stated, "The outstanding Phase 1 clinical data and clinical data from China for Taletrectinib enabled us to obtain approval for the clinical trial modification," adding, "If designated as an orphan drug, Taletrectinib can receive conditional sales approval immediately after completing this Phase 2 trial and be marketed."

Taletrectinib is an anticancer new drug substance that blocks and inhibits the activation of fusion mutant proteins of 'ROS-1' and 'tyrosine receptor kinase (NTRK),' found in various solid tumors including non-small cell lung cancer, thereby preventing metastasis and eliminating cancer.

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