The FOURTH BTD! TROP2-ADC SKB264 (MK-2870) Granted Breakthrough Therapy designation for 1L unresectable locally advanced, recurring or metastatic PD-L1 Negative TNBC by NMPA

On 8 th  March 2024, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK, Kelun-Biotech)’s innovative core product TROP2-ADC SKB264 (also known as MK-2870) was granted Breakthrough Therapy Designation（BTD） by the Center for Drug Evaluation（ CDE） of the National Medical Products Administration (NMPA) of China for first-line treatment of unresectable locally advanced, recurrent or metastatic PD-L1 negative  triple negative breast cancer (TNBC). SKB264 (MK-2870) is jointly developed by Kelun-Biotech and MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA).   This is the fourth Breakthrough Therapy Designation for SKB264 (MK-2870) granted by the NMPA. Previously, SKB264 (MK-2870) was granted BTD for: July 2022, locally advanced or metastatic TNBC. January 2023, EGFR-mutant locally advanced or metastatic non-small cell lung cancer (NSCLC) after progression on EGFR tyrosine kinase inhibitor (TKI) therapy. June 2023,   locally advanced or metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer in patients who have previously received at least two lines of systematic chemotherapy.   Breast cancer is one of the most common malignant tumors in women, with its incidence showing an increasing trend year by year. The International Agency for Research on Cancer (IARC) and the World Health Organization (WHO) estimated that in 2020, there were over 2.26 million new cases of breast cancer globally, accounting for 11.7% of all tumors, making it the most prevalent cancer [1]. Triple-negative breast cancer (TNBC) is a clinical subtype that is negative for estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2), comprising 10.0% to 20.8% of all breast cancer types. Triple-negative breast cancer is characterized by high heterogeneity, a high rate of recurrence and metastasis, and a poorer prognosis compared to other types of breast cancer. It lacks effective and specific treatment methods [2]. Currently, the primary treatment for PD-L1 negative TNBC is chemotherapy, which offers limited survival benefits, highlighting the urgent need for new treatment plans. For patients with inoperable locally advanced, recurrent, or metastatic PD-L1 negative triple-negative breast cancer, the first-line standard treatment in China still involves chemotherapy, including single-agent or combination chemotherapy [3]. Compared to single-agent chemotherapy, combination chemotherapy has greater toxicity and offers limited survival benefits.   BTD  is designed to expedite the development of new drugs for serious diseases that have shown significant efficacy or safety over existing therapies in preliminary clinical trials. For new drugs included in the Breakthrough Therapy List, CDE will prioritize the allocation of resources for communication, enhanced guidance, and promotion of drug development. If the relevant conditions have been assessed to be met, an application for conditional approval and an application for priority review and approval may also be submitted at the time of the application for drug marketing authorization. This will help accelerate the SKB264 (MK-2870) development process and address the unmet clinical needs of Chinese patients as soon as possible.   参考文献： [1] Cancer statistics in China and United States, 2022: profiles, trends, and determinants. Chin Med J(Engl).2022 Feb 9; 135(5):584-590. [2]  三阴性乳腺癌含铂方案临床应用专家共识（ 2021 版） . 中华肿瘤防治杂志 2021 年 6 月第 28 卷第 12 期 . [3]  《中国临床肿瘤学会（ CSCO ）乳腺癌诊疗指南 2023 版》 .

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