anbenitamab (KN026)

Compared with chemotherapy alone, anbenitamab plus chemotherapy demonstrated clinically meaningful superior PFS and OS in patients with HER2-positive GC/GEJ adenocarcinoma whose previous therapy containing trastuzumab had failed. These findings warrant confirmation in the final analysis.

P2/3, N=490, Not yet recruiting, Shanghai JMT-Bio Inc.

Both HER2 and ESR1 are determinant of KN026 efficacy in advanced HER2-positive breast cancer, implying the potential of KN026 combined with endocrine therapy in HER2- and ER-positive breast cancer.

P2, N=153, Not yet recruiting, Shanghai JMT-Bio Inc.

P3, N=880, Recruiting, Shanghai JMT-Bio Inc. | Not yet recruiting --> Recruiting | Trial primary completion date: Jul 2026 --> Jul 2025

P3, N=520, Recruiting, Shanghai JMT-Bio Inc. | Not yet recruiting --> Recruiting

The combination of KN046 and KN026, as a chemo free regimen, demonstrated favorable clinical efficacy with comparative toxicities in pre-treated patients with advanced HER2-positive breast cancer.

In the other HER2-positive solid tumor subgroup (n = 34), the ORR was 52.9% (95%CI 35.1%,70.2%). Thus, KN026 plus KN04 exhibits promising efficacy and acceptable safety profiles in HER2-positive nonbreast cancer, as does the 1st-line treatment for GC.

KN026 plus docetaxel showed promising efficacy and a manageable safety profile in first-line treatment of HER2-positive recurrent/metastatic breast cancer.

P3, N=520, Not yet recruiting, Shanghai JMT-Bio Inc.

Despite the unfavorable prognosis associated with advanced GC, the implementation of personalized treatment approaches may still prove beneficial for select patients. In patients with HER2-positive GC with extensive metastatic involvement, the use of the HER2-targeted combination with apatinib has demonstrated the potential to prolong both PFS and overall survival.