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

Anbenitamab plus chemotherapy for previously treated HER2-positive gastric or gastroesophageal carcinomas (GC/GEJC): Updated overall survival (OS) analysis of KC-WISE (ESMO 2026) - No abstract available

Clinical • Late-breaking abstract • Gastric Cancer • Gastroesophageal Cancer • Oncology • Solid Tumor • HER-2

Neoadjuvant Anbenitamab and HB1801 in ERBB2-Positive Breast Cancer: A Phase 3 Randomized Clinical Trial. (PubMed, JAMA Oncol) - P3 | "This randomized clinical trial found that neoadjuvant anbenitamab and HB1801 in patients with breast cancer significantly improved the tpCR rate compared with standard therapy with a highly manageable safety profile. This new combination may offer an improved treatment option, although long-term survival follow-up analyses are warranted."

Clinical • Journal • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Anbenitamab: First Approval. (PubMed, Drugs) - "Anbenitamab, in combination with chemotherapy, is approved for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have previously received at least one trastuzumab-containing therapy. This article summarizes the milestones in the development of anbenitamab leading to this first approval for gastric or GEJ cancer."

Journal • Breast Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Anbenitamab plus albumin-bound docetaxel (nab-docetaxel) ± carboplatin (Cb) versus trastuzumab and pertuzumab plus docetaxel (THP) ± Cb as neoadjuvant therapy for HER2-positive early or locally advanced breast cancer: A randomized, open-label, multicenter, phase 3 trial. (ASCO 2026) - P3 | "Anbenitamab plus nab-docetaxel ± Cb significantly improved tpCR rate compared with standard of care as neoadjuvant therapy in patients with early or locally advanced HER2-positive breast cancer, with a manageable safety profile. These results support Anbenitamab-based regimen as a potential new standard of care."

Clinical • Late-breaking abstract • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Leukopenia • Neutropenia • Oncology • Solid Tumor • HER-2

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

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

Anbenitamab plus albumin-bound docetaxel in patients (pts) with HER2-positive advanced breast cancer (BC): A randomized phase III study (ESMO 2026) - No abstract available

Clinical • Late-breaking abstract • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

HER2-Targeted Bispecific Antibodies in Advanced Gastric and Gastroesophageal Junction Cancer: A Systematic Review and Meta-Analysis (ACG 2026) - "Eligible studies included adults with HER2-positive advanced or metastatic gastric or gastroesophageal junction adenocarcinoma treated with zanidatamab or anbenitamab-based therapy versus trastuzumab-based or standard therapy. Four studies including 1,198 patients met eligibility criteria. HER2-targeted bispecific antibody combination therapy was associated with longer progression-free survival compared with control regimens (mean difference 4.27 months, 95% confidence interval 3.33â5.20; P=0.0026; I²=0%) and longer overall survival (mean difference 6.32 months, 95% confidence interval 0.38â12.26; P=0.0470; I²=0%). Any-grade treatment-related adverse events were not significantly different between groups (risk ratio 1.19, 95% confidence interval 0.20â7.24; I²=78.6%), and grade â¥3 treatment-related adverse events were also not statistically different (risk ratio 1.78, 95% confidence interval 0.01â280.23; I²=69.1%)."

Bispecific • Metastases • Retrospective data • Review • Gastric Adenocarcinoma • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2

Alphamab Oncology…announced that the New Drug Application (NDA) for the third indication of Anbenitamab…has been accepted by China’s National Medical Products Administration (NMPA) and included in the priority review and approval procedure. (Alphamab Press Release) - "The submitted indication is for the first‑line treatment of unresectable or metastatic HER2‑positive adult breast cancer in combination with docetaxel (albumin‑bound) (HB1801)...The NDA is primarily supported by a pivotal phase III clinical study (study code: KN026-003/Healer)."

China filing • Priority review • HER2 Positive Breast Cancer

SPC Pharmaceutical Group Limited…is pleased to announce that the new drug application for Anbenitamab (KN026)…in combination with the Group’s self-developed docetaxel for injection (albumin-bound) ('HB1801') for neoadjuvant treatment, has been accepted by…the NMPA…and has been included in the priority review and approval procedure (HKEXnews) - "The indication for this new drug application is Anbenitamab in combination with docetaxel (albumin-bound) ± carboplatin as neoadjuvant therapy for the treatment of HER2-positive early or locally advanced breast cancer in adults....This marketing application is primarily based on a pivotal Phase III clinical trial (Study No.: KN026-004/Neo-Healer) that enrolled patients with early-stage or locally advanced HER2-positive breast cancer."

China filing • Priority review • HER2 Positive Breast Cancer

KN026-004: 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 | Active, not recruiting | Sponsor: Shanghai JMT-Bio Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Prognostic and therapeutic implications of EGFR expression in HER2-positive advanced gastric cancer (ESMO-GI 2026) - "ORR was also lower in patients with high EGFR expression (33.3% vs 61.5%). Conclusions High EGFR expression was associated with inferior outcomes in patients with HER2-positive mGC/GEJC treated with trastuzumab-based chemotherapy, supporting the ongoing development of newer agents such as zanidatamab, anbenitamab or HLX22 that disrupt interactions between HER2 and EGFR in this population."

Metastases • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • EGFR • HER-2

Alphamab Oncology has announced that China’s National Medical Products Administration (NMPA) granted a breakthrough therapy designation to its anti-HER2 bispecific antibody, Anbenitamab. (TipRanks) - "Co-developed with JMT-Bio, a subsidiary of CSPC Group, the drug received this designation for the first-line treatment of unresectable or metastatic HER2-positive breast cancer in combination with albumin-bound docetaxel...The decision is supported by data from a Phase III clinical trial, where the combination of Anbenitamab and HB1801 significantly improved progression-free survival compared to the standard THP regimen, while maintaining a favorable safety profile."

Breakthrough therapy • Non-US regulatory • HER2 Positive Breast Cancer

Comparative efficacy of HER2-targeted therapies in previously treated HER2-positive gastric cancer: a network meta-analysis (EACR 2026) - "In contrast, trastuzumab emtansine, trastuzumab continuation, and lapatinib-based therapy did not show improved survival compared with chemotherapy. This network meta-analysis suggests that recent HER2-targeted therapies, including trastuzumab deruxtecan and anbenitamab, may improve survival in previously treated HER2-positive gastric cancer. These findings may help support treatment selection in this setting."

Retrospective data • Gastric Cancer • Oncology • Solid Tumor

A Clinical Study of SYS6023 Combination Therapy for Advanced Breast Cancer (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd. | Not yet recruiting ➔ Recruiting | N=114 ➔ 36

Enrollment change • Enrollment open • Breast Cancer • Oncology • Solid Tumor

Bispecific antibodies in breast cancer: A systematic landscape analysis of clinical trials. (ASCO 2026) - "Across three phase II HER2-directed BsAb studies, objective response rates ranged 27–76%, with complete responses observed in at least five patients (zenocutuzumab n = 2, KN026 n = 3). The BsAb clinical landscape in breast cancer is rapidly expanding with marked mechanistic heterogeneity and enrichment of HER2-directed strategies. Early outcomes from select agents show meaningful antitumor activity, supporting continued development of oncogene-targeted and immune-modulating BsAbs. Distribution of bispecific antibody clinical trials in breast cancer by target combination and phase."

Bispecific • Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Neutropenia • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD73 • HER-2 • ICOS • MSLN • TIGIT

PHASE III clinical study of anbenitamab (KN026) as first-line treatment for HER2+ advanced breast cancer met primary endpoint (HKEXnews) - "As assessed by the IDMC, KN026 in combination with HB1801 significantly prolonged PFS and reduced the risk of disease progression or death as compared with the THP regimen, and also showed a trend of overall survival benefit. Detailed data from the study will be presented at an upcoming international academic conference."

DSMB • P3 data • HER2 Positive Breast Cancer

Recent Advances in the Treatment of HER2-Altered Solid Tumors (PubMed, Gan To Kagaku Ryoho) - "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)...."

IO biomarker • Journal • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Interstitial Lung Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • HER-2

ASCO 2026: Anbenitamab Improves Pathologic Complete Response in HER2-Positive Early Breast Cancer (DocWire) - "Patients treated with the anbenitamab-based regimen achieved a significantly higher BIRC-assessed tpCR rate compared with those receiving THP (62.4% vs 51.2%) meeting its primary endpoint. This represented an absolute improvement of 11.4% and was statistically significant (one-sided P = .0036). Similar findings were observed using investigator-assessed tpCR rates, which were 63.9% and 51.2%, respectively. The benefit of anbenitamab was consistent across all prespecified subgroups. Breast pCR rates were also significantly higher with anbenitamab than with THP (64.6% vs 55.0%; one-sided P = .0099)."

P3 data • HER2 Positive Breast Cancer

CSPC Pharmaceutical Group announced that Anbenitamab Injection, marketed as Ennituo and co-developed with Jiangsu Alphamab Biopharmaceuticals, has received marketing authorisation from China’s National Medical Products Administration. (TipRanks) - "The approval is backed by pivotal Phase II/III data showing Ennituo plus chemotherapy significantly extended progression-free and overall survival versus standard chemotherapy, with consistent benefits across subgroups and a favourable safety profile."

China approval • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

A Clinical Study of SYS6023 Combination Therapy for Advanced Breast Cancer (clinicaltrials.gov) - P2 | N=114 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

New P2 trial • Breast Cancer • Oncology • Solid Tumor

Case Report: Sustained complete response achieved in a patient with advanced HER-2 positive gastric cancer after 4 years of chemotherapy-free treatment. (PubMed, Front Oncol) - "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."

Journal • Gastric Adenocarcinoma • Gastric Cancer • Oncology • Solid Tumor • HER-2

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

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

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

2026 ASCO Preview | Results from Phase III Study of Anbenitamab (KN026) Combined with HB1801 in Neoadjuvant Treatment for Breast Cancer Selected for LBA Oral Presentation (PRNewswire) - "The results demonstrated that compared with the current standard of care regimen (TCbHP), the KN026 combination therapy significantly improved the total pathological complete response (tpCR) in patients."

Late-breaking abstract • P3 data • HER2 Positive Breast Cancer