Ennituo (anbenitamab)

Antibody-drug conjugates (ADCs), led by trastuzumab deruxtecan, have established clinically meaningful activity across multiple solid tumors in HER2 IHC 3+ populations and have further expanded into HER2-low and ultralow expression settings, supporting the concept of HER2 as a biological continuum rather than a binary biomarker...In gastroesophageal adenocarcinoma, treatment options beyond trastuzumab-based regimens continue to diversify: ADC-based standards in later lines are being complemented by next-generation HER2 antibodies, inclu ding recent phase Ⅲ evidence supporting anbenitamab after prior trastuzumab exposure, which may further inform sequencing decisions. Collectively, these advances highlight an emerging precision model in which therapeutic selection and rational sequencing are guided by integrated assessment of HER2 protein expression, ERBB2 genomic status, prior HER2-directed exposure, and toxicity risk (notably ADC-associated interstitial lung disease). Standardization of high-fidelity diagnostic workflows-spanning IHC/ISH quality assurance, re-biopsy when feasible, and context-appropriate use of circulating tumor DNA-will be essential to ensure consistent patient identification and to enable optimal deployment of ADCs, TKIs, and antibody-based therapies across histologic boundaries.

P2, N=114, Not yet recruiting, CSPC Megalith Biopharmaceutical Co.,Ltd.

The patient was enrolled in a clinical study and received a combination of KN026 and KN046 targeted therapy with immunotherapy...The combination of anti-HER-2 bispecific targeting therapy and PD-1/CTLA-4 bispecific immunotherapy demonstrated promising efficacy and a favorable safety profile in this patient with advanced HER2-positive gastric cancer, achieving durable complete response without chemotherapy. This case provides a rationale for further exploring chemotherapy-free strategies using dual bispecific antibodies in carefully selected patients.

P3, N=1800, Recruiting, Shanghai JMT-Bio Inc. | Not yet recruiting --> Recruiting

P3, N=1800, Not yet recruiting, Shanghai JMT-Bio Inc.

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