[Asia Economy Reporter Jang Hyowon] NewG Lab Pharma's drug development specialist subsidiary, NewG Lab Therapeutics, announced on the 25th that partial response was confirmed in all three patients in the first-line treatment group during the interim efficacy evaluation of the Phase 2 clinical trial of the non-small cell lung cancer treatment drug, Taletrectinib.
Additionally, in the clinical trial targeting the second-line treatment group, partial response was observed in 3 out of 6 patients. "Partial Response" refers to a situation where the size of cancer lesions is reduced by more than 30% after treatment, indicating a significant improvement in the patient's condition.
This interim evaluation far exceeds the global Phase 2 clinical trial interim results of Taletrectinib presented last year at the American Society of Clinical Oncology (ASCO) by the global pharmaceutical company Anchor Therapeutics (Anchor). According to Anchor's announcement, Taletrectinib showed an objective response rate (ORR) of 92.5% in the first-line treatment group and 50% in the second-line treatment group.
Pfizer's Xalkori, the standard treatment for non-small cell lung cancer with ROS-1 mutation, had an objective response rate of 73% in the first-line treatment group at the time of approval, and Roche's Rozlytrek was only 78%. Taletrectinib shows much superior efficacy compared to these, and the company explained that it will be a better treatment option for patients in the future.
NewG Lab Therapeutics is conducting a global Phase 2 clinical trial of Taletrectinib for non-small cell lung cancer simultaneously in Korea, the U.S., and Japan in collaboration with Anchor. In Korea, the goal is to recruit at least 12 patients, and so far, 10 patients have been recruited. Among the 9 patients currently undergoing clinical trials, partial response has been confirmed in 6, indicating successful progress of the trial.
A representative of NewG Lab Pharma stated, "We plan to complete Phase 2 clinical trials within the first half of this year and submit a New Drug Application (NDA) to the Ministry of Food and Drug Safety after receiving expedited review designation." They added, "Having received Breakthrough Therapy Designation (BTD) from the U.S. FDA last year, conditional approval for use is possible as soon as the trials are completed, so rapid commercialization can also be expected."
The interim results for the first-line treatment group come from clinical trials conducted at Seoul Asan Medical Center, Korea University Guro Hospital, and Pusan National University Hospital. Additionally, clinical trials are ongoing at Hwasun Chonnam National University Hospital and Pusan National University Yangsan Hospital, and progress updates on these will be announced soon.
© The Asia Business Daily(www.asiae.co.kr). All rights reserved.
