Merck's Class 1 Oncology Drug MK-6070 Granted IND Approval in China for Small Cell Lung Cancer

Feb 20, 2025 14:34 CST Updated 14:34

MSD

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Today (February 20), ChinaThe Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has recently announced,MSD's申报的1类新药注射用MK-6070获得临床试验默示许可，拟开发治疗小细胞肺癌。公开资料显示，MK-6070（曾用名：HPN328）是A Trispecific T-Cell Engager Targeting DLL3According to public channel inquiries, this is the first time that the product has been approved for an IND in China.

Screenshot source:CDE Official Website

Public information shows that MK-6070 is a T-cell engager targeting DLL3, which includes three binding domains designed to direct T cells to kill cancer cells expressing DLL3, includingAnti-DLL3For targeted binding, anti-CD3 for T-cell binding, and anti-albumin for extended half-life.。DLL3 is a Notch inhibitory ligand that is highly expressed in small cell lung cancer (SCLC) and other neuroendocrine tumors, but rarely expressed in normal tissues, making it a promising therapeutic target.

In January 2024, MSD announced approximately $680 millionAcquisitionHarpoon Therapeutics, thereby acquiring a series of T-cell engager therapies under investigation, including those in Phase 1/2 clinical development at the time.MK-6070Harpoon Therapeutics has made significant progress in the field of tumor immunotherapy, developing a series of innovative T-cell engagers based on the Tri-specific T-cell Activating Construct (TriTAC) platform. This engineered protein technology aims to direct the patient's own immune cells to attack tumor cells.

In August 2024, Daiichi Sankyo and MSD announced the expansion of their existing global co-development and commercialization agreement to include MSD's investigational therapy in addition to three DXd antibody-drug conjugates under research.MK-6070。The two companies will share R&D and commercialization costs globally., while MSD will receive a $170 million upfront payment.

At the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, researchers presented the Phase 1/2 clinical study results of MK-6070 in small cell lung cancer (SCLC) and other neuroendocrine carcinomas (NEC). As of January 5, 2024, 86 patients from 14 cohorts received MK-6070 across 14 dose cohorts ranging from 0.015 to 24 mg. Among the evaluable patients treated in the dose optimization cohort,The confirmed objective response rate (mORR) in SCLC patients was 50% (12/24), with one complete response (CR). In NEC (excluding NEPC), the confirmed ORR was 44% (4/9), with one CR.MK-6070 exhibits linear PK, with exposure increasing proportionally.The median half-life is 71 hours.A transient increase in cytokines and T-cell activation was observed within 24 hours after dosing. The researchers believe that MK-6070 is well-tolerated and shows clinical activity in SCLC, NEC, and NEPC.

According toClinicalTrialsAccording to the official website, MK-6070 is currently in Phase 1/2 clinical trials for participants with SCLC and other advanced cancers related to DLL3 expression. The recent approval of this product for clinical use in China indicates that it will also enter the clinical research phase in China.

ReferenceReferences:

[1] Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. Retrieved Feb 20，2025, from https://www.cde.org.cn/main/xxgk/listpage/da6efd086c099b7fc949121166f0130c

[2]KOSELUGO® (selumetinib) Showed Significant and Clinically Meaningful Improvement in Daiichi Sankyo and Merck & Co., Inc., Rahway, NJ, USA Enter into Global Development and Commercialization Agreement for MK-6070. Retrieved August 6, 2024, from https://www.daiichisankyo.com/files/news/pressrelease/pdf/202408/20240806_E2.pdf

[3]Updated results from a phase 1/2 study of HPN328, a tri-specific, half-life (T1/2) extended DLL3-targeting T-cell engager in patients (pts) with small cell lung cancer (SCLC) and other neuroendocrine cancers (NEC).. Retrieved May 23，2024, from https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.8090

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