NewgLab Pharma Applies for Global Phase 2 IND of Lung Cancer Treatment... "Aiming for Conditional Approval"

[Asia Economy Reporter Hyunseok Yoo] NewG Lab Pharma announced on the 1st that it has submitted the clinical trial protocol (IND) for the Phase 2 clinical trial of the internationally recognized non-small cell lung cancer treatment drug ‘Taletrectinib’ to the Korea Ministry of Food and Drug Safety (MFDS).

Taletrectinib is an anticancer new drug substance developed by Japan’s Daiichi Sankyo, and has successfully completed Phase 1 clinical trials in Japan and the United States. In Phase 1, one case of ‘complete remission’ was observed where the cancer completely disappeared after administration, and the drug was confirmed to penetrate the meninges (blood-brain barrier) to suppress metastatic brain cancer.

In Phase 1, Taletrectinib showed an ‘objective response rate (ORR)’ of 93% (14/15) and a ‘disease control rate (DCR)’ of 93% (14/15) in patients without prior treatment experience with the competing drug Xalkori, and an ORR of 60% (3/5) and DCR of 100% (5/5) in patients with prior Xalkori treatment experience.

These early clinical data were presented as a poster at the 2021 ASCO (American Society of Clinical Oncology), drawing international attention for the drug’s efficacy and safety. Taletrectinib is expected to directly compete with Pfizer’s non-small cell lung cancer treatment drug ‘Xalkori’ (generic name Crizotinib).

NewGen Therapeutics plans to conduct clinical trials in this domestic Phase 2 study targeting ‘non-small cell lung cancer ROS-1 mutation patients’ who are ‘Xalkori (oral) patients’ and ‘Xalkori-resistant patients’. If the product is successfully launched in the future, it is expected to be the only treatment option for Xalkori-resistant patients who currently have no treatment methods.

Currently, Innovent Biologics is separately conducting a Phase 2 clinical trial of Taletrectinib in China, and NewGen Therapeutics is conducting a joint global Phase 2 clinical trial in Korea, the United States, and Japan together with the US company Anhui Therapeutics.

Shinyoung Han, Head of Clinical Division at NewG Lab Pharma, said, “Since Taletrectinib has already shown excellent efficacy in Phase 1, it is expected that IND approval for global Phase 2 clinical trials will be rapidly obtained in Korea, the United States, and Japan,” adding, “We will prepare to conduct the first patient enrollment and dosing as well as the initial tumor evaluation in the second half of this year.” He continued, “After completing Phase 2, we plan to obtain conditional approval for use in Korea and acquire marketing authorization for the shortest possible period.”

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