China-based Alphamab Oncology (HKG: 9966) and CSPC Pharmaceutical Group Ltd (HKG: 1093) have announced receiving approval in China to conduct a registrational study for KN026 combined with docetaxel (albumin bound) in first-line HER2 positive recurrent and metastatic breast cancer.
Design and Objectives of the Phase III Study
The randomized, controlled, open, multi-center Phase III study is intended to enroll 880 subjects and is designed to assess the efficacy and safety of the combination therapy compared with trastuzumab combined with pertuzumab plus docetaxel. The primary endpoint of the study is progression-free survival (PFS) as evaluated by the Independent Review Committee (IRC).
KN026: A Next-Generation HER2-Targeted Bispecific Antibody
KN026 is a potential next-generation HER2-targeted bispecific antibody (BsAb) with a demonstrated good safety and tolerability profile. It has shown anti-tumor activities in HER2 positive breast cancer across multiple studies. A Phase II study for the combination in first-line HER2 positive recurrent/metastatic breast cancer indicated an objective response rate (ORR) of 76.4%, a median duration of response (mDoR) of 24.0 months, and a disease control rate (DCR) of 100%.
Partnership and Licensing Agreement
CSPC Pharma subsidiary Shanghai JMT Biotechnology Co., Ltd struck a licensing deal with Alphamab in August of the previous year, securing exclusive development and commercialization rights to KN026 combined with KN046, a bispecific antibody targeting both programmed cell death-1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), in mainland China. This agreement positions CSPC Pharma as the marketing authorization holder (MAH) for KN026 in the region. The drug is currently subject to multiple Phase I/II clinical studies in both China and the US.-Fineline Info & Tech
