NewG Lab Pharma Subsidiary Achieves 75% Partial Response Rate in Domestic Phase 2 Lung Cancer Trial, Raising Expectations for Clinical Success

[Asia Economy Reporter Jang Hyowon] NewgLab Pharma's subsidiary, NewgLab Therapeutics, has confirmed a 75% partial response rate (PR) in the Phase 2 clinical trial of its non-small cell lung cancer treatment, Taletrectinib, raising expectations for clinical success. Partial response refers to a situation where, based on the objective response rate (ORR), the size of cancer lesions is reduced by more than 30% and no metastasis to other organs occurs for more than 4 weeks, indicating verified drug efficacy.

NewgLab Therapeutics announced on the 24th that in the Phase 2 clinical trial of Taletrectinib, a ROS-1 inhibitor for non-small cell lung cancer being conducted at Seoul Asan Medical Center and Hwasun Chonnam National University Hospital, partial response was confirmed in 3 out of 4 patients who received the drug for more than 6 weeks.

This result was observed in a trial targeting the "second-line treatment group," patients who did not respond to or developed resistance to existing anticancer drugs. This once again proves the excellent therapeutic effect of Taletrectinib, drawing industry attention to future clinical trials.

In June, Taletrectinib received approval from the Korea Ministry of Food and Drug Safety (MFDS) to expand its clinical trial target from the existing second-line treatment group to include the first-line treatment group, thus changing its indication to both first- and second-line treatments. Taletrectinib is expected to show even greater efficacy in upcoming clinical trials targeting the first-line treatment group.

Globally, Taletrectinib has also demonstrated good therapeutic effects, including two cases of complete response in the first-line treatment group. According to the interim results of the global Phase 2 clinical trial presented this year at ASCO (American Society of Clinical Oncology) by the U.S. company AnHeart Therapeutics, Taletrectinib showed an objective response rate of 92.5% in the first-line treatment group and 50.0% in the second-line treatment group, including two complete responses. Furthermore, a high ORR of 91.7% was reported in patients with brain metastases.

This significantly exceeds the ORR of 73% at the time of approval for Pfizer’s first-line treatment drug Xalkori (Crizotinib) for the same indication, and also outperforms Roche’s Rozlytrek (Entrectinib), which had an ORR of 78%.

A NewgLab Pharma official stated, “The Phase 2 clinical trial results of Taletrectinib in Korea are data targeting the second-line treatment group, whose physical function is deteriorated and prognosis is poor. Especially, the symptom improvement observed in patients who received clinical treatment for more than 6 weeks is an encouraging result.”

He added, “Recently, BMS, a global pharmaceutical company, acquired Turning Point, which developed a similar drug called Repotrectinib, for over 5 trillion KRW, further increasing the market value of Taletrectinib. We plan to announce additional official interim results once data from more than 30% of patients in the Phase 2 trial are accumulated.”