anbenitamab (KN026) / Alphamab, CSPC Pharma - LARVOL DELTA

KN026 in combination with chemotherapy for previously treated HER2-positive gastric or gastroesophageal carcinomas (GC/GEJC): Interim analysis of KC-WISE (ESMO 2025) - P2/3 | "Treatment-related deaths were reported in 0 and 5 patients in the anbenitamab and control groups, respectively. Conclusions 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."

Combination therapy • Late-breaking abstract • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • HER-2

Alphamab Oncology Announces the First Patient Dosed in a Phase III Clinical Study of Anbenitamab (KN026) Combined with HB1801 and Chemotherapy as Adjuvant Treatment of Breast Cancer (PRNewswire-Asia) - "KN026-007 is a randomized, controlled, open-label, multicenter Phase III clinical study, which is expected to enroll approximately 1,800 patients with resectable HER2-positive BC who have histologically confirmed involvement of four or more regional lymph nodes following surgery."

Trial status • HER2 Positive Breast Cancer

A best-in-class HER2xHER2 novel biparatopic antibody-drug conjugate with an efficacious, low-toxicity design that maximizes antibody functionality (AACR 2026) - "When combined with HLX02 (a trastuzumab biosimilar), HLX22 increases internalization of HER2 homodimers and HER2/EGFR heterodimers, reducing cell proliferation signals. This combination shows stronger antitumor effects than HLX02 plus HLX11 (a pertuzumab biosimilar) both in vitro and in vivo...Preliminary toxicology in cynomolgus monkeys was assessed at 60 mg/kg, administered every three weeks for three cycles. The HER2xHER2 biparatopic ADC demonstrated superior internalization efficiency than KN026 (a HER2-targeted bispecific antibody) and trastuzumab deruxtecan in BT474 and NCI-N87 cell lines... We have developed a potential best-in-class HER2xHER2 novel biparatopic ADC that exhibits a superior therapeutic index, antibody-mediated signaling blockade. The preclinical findings support clinical development in breast and gastric cancers, with the hope that the improved therapeutic index of this agent confers survival benefit."

ADC • Gastric Cancer • Oncology • Solid Tumor • EGFR

A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer (clinicaltrials.gov) - P3 | N=1800 | Not yet recruiting | Sponsor: Shanghai JMT-Bio Inc.

New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A Study of KN026-based Combination Therapy in HER2-positive Gastric Cancer (clinicaltrials.gov) - P2/3 | N=490 | Not yet recruiting | Sponsor: Shanghai JMT-Bio Inc.

New P2/3 trial • Gastric Cancer • Oncology • Solid Tumor • HER-2 • PD-L1

Anbenitamab is a new second-line option in G/GEJ adenocarcinoma. (PubMed, Nat Rev Clin Oncol) - No abstract available

Journal • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology

Anbenitamab in previously treated HER2-positive gastric cancer (KC-WISE): pre-specified interim analysis of a randomized, phase III clinical trial. (PubMed, Ann Oncol) - "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."

Journal • P3 data • P3 data: top line • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Hematological Disorders • Leukopenia • Neutropenia • Oncology • Solid Tumor • HER-2

Alphamab Oncology… announced that the results from a phase III clinical study for the treatment of HER2-positive gastric or gastroesophageal junction cancer (GC/GEJ) of anbenitamab injection (KN026) (The Manila Times) - "Significant improvement in PFS: The Anbenitamab Group achieved a significantly prolonged median PFS. The median PFS was 7.1 months in the Anbenitamab Group versus 2.7 months in the SOC Control Group; Clinically meaningful survival benefit: In patients with second-line HER2-positive gastric cancer, the Anbenitamab Group achieved a median OS approaching 20 months for the first time. The median OS was 19.6 months and 11.5 months in the Anbenitamab and Control groups, respectively; The Anbenitamab Group exhibited a favorable tolerability profile."

P3 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

Spatial molecular analyses reveal key features associated with response to KN026 in advanced HER2-positive breast cancer. (PubMed, Br J Cancer) - "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."

Journal • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • CDK12 • ER • HER-2 • TFAP2A

Spatial molecular analyses reveal key features associated with response to KN026 in advanced HER2-positive breast cancer (Nature) - "Compared to the tumor regions with non-objective response (OR), those with OR had high expression of CALML5, TFAP2B, and ERBB2, and relatively low expression of ESR1 in tumor cells at baseline. The expression of ESR1 had a tentative association with PI3K/AKT and NOTCH signaling pathways which were downstream or interactive pathways of HER2 target and also acted as interactive pathways of ER-mediated signaling. The co-expression of ERBB2 and CDK12 emerged as a distinctive signature of OR. KN026 treatment also reshaped intratumoral activated T- and B-cell subtypes in hot-tumor regions, regardless of myeloid-derived cells."

Preclinical • HER2 Positive Breast Cancer

Anbenitamab in combination with chemotherapy in patients with HER2-positive gastric or gastroesophageal junction carcinoma who failed previous therapy containing trastuzumab: a multicenter, phase II study (KC-WISE 01). (PubMed, Cancer Commun (Lond)) - No abstract available

Journal • P2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2

Anbenitamab Plus Chemotherapy Significantly Improves Survival in Previously Treated HER2-Positive Gastric or GEJ Cancer (HMPL Global) - "Interim Results From the Phase 3 TKC-WISE Trial...A total of 188 patients were randomized: 95 to the anbenitamab plus chemotherapy group and 93 to the chemotherapy-alone group. At interim analysis, the combination demonstrated a marked improvement in PFS (median, 7.1 vs 2.7 months; hazard ratio [HR], 0.25; 95% CI, 0.17 to 0.39; P <.0001) and OS (median, 19.6 vs 11.5 months; HR, 0.29; 95% CI, 0.17 to 0.50; P <.00001). The objective response rate was substantially higher with anbenitamab plus chemotherapy (56%) compared with chemotherapy alone (11%), indicating robust tumor activity....Safety findings were consistent with known profiles of HER2-targeted therapy and cytotoxic agents."

P3 data • Gastric Cancer • Gastroesophageal Cancer • HER-2

NEW DRUG APPLICATION FOR KN026 (ANBENITAMAB INJECTION) ACCEPTED BY THE NMPA (HKEXnews) - "Its indication is for use in combination with chemotherapy for the treatment of patients with HER2-positive locally advanced, recurrent, or metastatic gastric or gastroesophageal junction cancer who have failed at least one prior systemic therapy....This new drug application is primarily based on a pivotal Phase II/III clinical trial (KC-WISE)."

China filing • Gastric Cancer • Gastroesophageal Cancer

KN026:…Events after the Reporting Period (PRNewswire-Asia) - "(i) In July 2025, the...IND application for a phase III clinical trial of KN026 as first-line treatment for HER2-positive GC/GEJ was accepted by the CDE; (ii) In July 2025, the first interim analysis results from the phase III clinical study of KN026 in combination with chemotherapy as second-line or above treatment of HER2-positive GC/GEJ were accepted by the 2025...ESMO Congress and will be presented during the Congress in October."

New P3 trial • P3 data • Gastric Cancer • Gastroesophageal Cancer

KN026:…Expected Milestones in 2025 (PRNewswire-Asia) - "(i) A New Drug Application (NDA) will be submitted in China for KN026 combined with chemotherapy as second-line or above treatment for HER2-positive GC/GEJ; (ii) Enrollment of all patients will be completed in the phase III clinical trial of KN026 combined with albumin-bound docetaxel HB1801 as neoadjuvant treatment of HER2-positive early or locally advanced BC."

China filing • Enrollment status • Gastric Cancer • Gastroesophageal Cancer • HER2 Positive Breast Cancer

Longitudinal tissue analysis and correlation of microenvironmental changes with combined immunotherapy and targeted therapy response in metastatic breast cancer. (ASCO 2025) - P2 | "Funded by Guangdong Science and Technology Department(2023B1212060013, 2022B1515020100, 2022A1515012238), the Natural Science Foundation of China (82273033, 82072924, 82072906) Clinical Trial Registration Number: NCT04521179 Background: The ability to interrogate changes within the tumor microenvironment before, during and following therapeutic intervention could yield important understanding of treatment response and causes for disease progression.Here we conducted a multicenter phase II clinical trial (NCT04521179) examining the effect of a novel CTLA-4/PD-L1 bispecific (KN046) antibody in combination with a a novel anti-HER2 bispecific (KN026) antibody in treatment resistant metastatic breast cancer... We identified that regulatory T cells are activated while effector T cells, natural killer cells, and dendritic cells were significantly depleted in non-responding tumors. The immune response in responsive patients was effectively enhanced, whereas in nonresponsive..."

Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CD4 • CD8 • CTLA4

JSKN003 Combined Treatment of HER2-positive Gastric Cancer (clinicaltrials.gov) - P2 | N=153 | Not yet recruiting | Sponsor: Shanghai JMT-Bio Inc.

New P2 trial • Gastric Cancer • Oncology • Solid Tumor

Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer. (clinicaltrials.gov) - P3 | N=880 | Recruiting | Sponsor: Shanghai JMT-Bio Inc. | Not yet recruiting ➔ Recruiting | Trial primary completion date: Jul 2026 ➔ Jul 2025

Enrollment open • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A Phase III Study of KN026 in Combination With HB1801 ± Carboplatin as Neoadjuvant Treatment for Early or Locally Advanced HER2-Positive Breast Cancer (clinicaltrials.gov) - P3 | N=520 | Recruiting | Sponsor: Shanghai JMT-Bio Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

A Pivotal Phase II/III Clinical Study of Anti-HER2 Bispecific Antibody KN026 Have Met the Primary Endpoint of PFS at Interim Analysis (PRNewswire) - P2/3 | N=286 | NCT05427383 | Sponsor: Shanghai JMT-Bio Inc. | "Alphamab Oncology...and CSPC Pharmaceutical Group...jointly announced that a phase II/III clinical trial of anti-HER2 bispecific antibody KN026 (Study ID: KN026-001) in combination with chemotherapy as second-line or above treatment of HER2-positive gastric cancer (GC) (including gastroesophageal junction cancer (GEJ)), has completed the first interim analysis and met the pre-specified primary endpoint of progression-free survival (PFS) as evaluated by an Independent Data Monitoring Committee (IDMC), with both statistical significance and clinical relevance....The interim PFS analysis results demonstrated that, compared to the current standard treatment, KN026 in combination with chemotherapy significantly improved PFS, reduced the risk of disease progression or death, and showed a trend toward OS benefit. Detailed data from this study will be presented at an upcoming international academic conference."

P2/3 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • HER-2

Safety and Efficacy of KN046 in combination with KN026 in Patients with advanced HER2-positive Breast Cancer: a Phase II Trial. (PubMed, Clin Cancer Res) - "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."

Journal • P2 data • Breast Cancer • Dermatology • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Pruritus • Solid Tumor • HER-2

Efficacy and safety of KN026, a bispecific anti-HER2 antibody, in combination with KN046, an anti-CTLA4/PD-L1 antibody, in patients with advanced HER2-positive nonbreast cancer: a combined analysis of a phase Ib and a phase II study. (PubMed, Signal Transduct Target Ther) - "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."

Journal • P1 data • P2 data • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CD4 • CTLA4 • HER-2

KN026 Plus Docetaxel Demonstrates Efficacy in HER2+ Metastatic Breast Cancer (OncLive) - P2 | N=68 | NCT04165993 | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd | "In the open-label, single-arm trial, among efficacy-evaluable patients (n = 55), the combination generated an objective response rate (ORR) of 76.4% (95% CI, 63.0%-86.8%), including 3 complete responses and 39 partial responses. The median duration of response (DOR) was not yet reached (NR; 95% CI, 20.7 months-NR). The 12-, 24-, and 30-month DOR rates were 85.2%, 59.3%, and 51.6%, respectively. Furthermore, the clinical benefit rate (CBR) was 85.5% (95% CI, 73.3%-93.5%)...At a median follow-up of 31.1 months (range, 0.8-41.4), among the safety-evaluable population, the median PFS was 27.7 months (95% CI, 18.0-NR); the 6-, 12-, 24-, and 30-month PFS rates were 87.4% (95% CI, 75.4%-93.8%), 76.3% (95% CI, 62.6%-85.5%), 54.2% (95% CI, 39.7%-66.6%), and 45.2% (95% CI, 30.9%-58.4%), respectively."

P2 data • Breast Cancer • HER2 Positive Breast Cancer

Exploring the role of bispecific and CAR-T cell therapies in gastric cancer: A systematic review and meta-analysis. (ASCO-GI 2025) - "Bispecific antibodies were MCLA-128 (25/138), catumaxomab (15/138), AK104 PD-1/CTLA-4 (16/138), ABL 001 DLL4VEGFA (19/138), and KN026 (25/138) while CART therapy was CT041 (38/138)... This analysis shows promising results in GC patients using bi-specific antibodies and CAR-T cell therapy. However, further clinical trials are needed to fully explore their potential."

CAR T-Cell Therapy • Retrospective data • Review • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CTLA4 • PD-1

Efficacy and safety of KN026 and docetaxel for HER2-positive breast cancer: a phase II clinical trial. (PubMed, Cancer Commun (Lond)) - "KN026 plus docetaxel showed promising efficacy and a manageable safety profile in first-line treatment of HER2-positive recurrent/metastatic breast cancer."

Journal • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2