Cipterbin (inetetamab) / 3SBio - LARVOL DELTA

Early use of CDK4/6 inhibitor combined with endocrine therapy plus anti-HER2 antibody may get more survival benefit in HR+/HER2+ advanced breast cancer: result from a phase II single-arm mini cohort study (CABC016) (SABCS 2025) - P2 | "Patients are treated with palbociclib at a dose of 125 mg daily on days 1 - 21 of a 28 - day cycle, plus trastuzumab (H, trastuzumab or inetetamab) or trastuzumab plus pertuzumab (HP) intravenously on day 1 of each 21-day cycle. ET options included aromatase inhibitor (AI), tamoxifen or fulvestrant depend on endocrine sensitivety, with ovarian suppression required for premenopausal patients... This mini cohort study showed palbociclib plus ET plus anti-HER2 antibody could be one of the optimal initial treatment options for metastatic setting of HR+/HER2+ breast cancer, especially for early use during ET-based regimen, even for stable brain disease."

Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Case Report: Effectiveness of Inetetamab combined with immunochemotherapy as first-line treatment in two cases of advanced gastric cancer with HER2 expression: a retrospective analysis. (PubMed, Front Oncol) - "They were treated with a combination of Inetetamab, Tislelizumab, and the XELOX regimen (Inetetamab 300mg administered on Day 1; Tislelizumab 200mg administered on Day 1; Oxaliplatin 150mg administered on Day 2; Capecitabine 1.5g orally twice daily on Days 1-14; repeated every 3 weeks per cycle). The findings of this study suggest a novel first-line treatment strategy for advanced gastric cancer, potentially improving treatment efficacy and quality of life for HER2-positive gastric cancer patients. Nevertheless, further clinical trials are warranted to validate the efficacy and safety of this treatment approach."

Journal • Retrospective data • Gastric Cancer • Oncology • Solid Tumor • HER-2

Combined treatment of inetetamab plus pyrotinib and vinorelbine in managing advanced HER2-positive breast cancer patients (ILLUMINE): a multicenter, retrospective, real-world study. (PubMed, Transl Breast Cancer Res) - "No severe TAAEs were observed during the investigation. The triple regimen of inetetamab plus pyrotinib and vinorelbine exhibited promising therapeutic effects and was tolerable for participants with HER2-positive ABC."

Journal • Real-world evidence • Retrospective data • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Leukopenia • Neutropenia • Oncology • Solid Tumor • HER-2

Efficacy and Safety of Inetetamab-Based Therapies in HER2-Positive Breast Cancer: A Systematic Review and Meta-Analysis (DGHO 2025) - "Inetetamab, a novel anti-HER2 monoclonal antibody, has shown promise as an alternative to trastuzumab, demonstrating comparable efficacy and safety in both neoadjuvant and metastatic settings. Inetetamab-based therapies demonstrate significant efficacy with a high CBR and ORR in HER2-positive breast cancer. While neutropenia and anemia are common adverse effects, their incidence is consistent with established HER2-targeted regimens. These findings support inetetamab as a viable therapeutic alternative, warranting further prospective validation to refine treatment protocols and enhance patient outcomes."

Retrospective data • Review • Anemia • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Neutropenia • Oncology • Solid Tumor • HER-2

Efficacy and Safety of Inetetamab-Containing Regimens in Patients with HER2-Positive Advanced Solid Tumors (ChiCTR) - P=N/A | N=30 | Not yet recruiting | Sponsor: Shanghai Geriatric Medical Center; Shanghai Geriatric Medical Center

New trial • Solid Tumor • HER-2

Evaluating the Impact of Monoclonal Antibodies on Survival Outcomes in Advanced Gastric Cancer: A Systematic Review of RCTs (ACG 2025) - "Pembrolizumab plus chemotherapy also significantly enhances survival outcomes. In Boku et al., 2021, nivolumab demonstrated a significant OS benefit over placebo (5.3 vs 4.1 months) and a modest PFS benefit (1.61 vs 1.45 months). In Kong et al., 2024, inetetamab improved PFS compared to trastuzumab (8.5 vs 7.3 months, P = 0.046), but OS (15.4 vs 14.3 months) was not significantly different. Kang et al., 2024 reported that bemarituzumab plus mFOLFOX6 significantly improved both PFS (12.9 vs 8.2 months) and OS (24.7 vs 12.9 months) compared to placebo."

Metastases • Review • Gastric Cancer • Oncology • Solid Tumor

Personalized Treatment for Invasive Ductal Breast Carcinoma with Lung and Liver Metastases Based on Patient-Derived Organoids: A Case Report. (PubMed, Onco Targets Ther) - "After treatment with erebulin, carboplatin and inetetamab sensitive revealed by the organoid drug sensitivity testing, partial response in lung metastasis and stable disease in liver metastasis were achieved. This typical case suggests that for the individual patients with advanced refractory breast cancer, especially those exhausting the standard treatment options, the PDOs may serve as an effective model for assessing individual drug sensitivity to optimize treatment decisions and improve treatment response."

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

A retrospective multicenter cohort study on the efficacy and safety of inetetamab and pyrotinib combined with chemotherapy (IPyC) for HER2+ metastatic breast cancer (ESMO 2025) - "Funding Fujian Provincial Health Technology Project (grant number: 2022GGB012). Table: 545P Characteristics 1st L 2nd L Higher L Median age (range), years 47 (26-65) 49 (27-78) 47 (27-74) ER/PR Positive 51 48 47 Negative 45 50 60 HER2 status IHC 3+ 69 80 91 IHC 2+ & FISH + 27 18 16 Previous anti-HER2 therapy H or HP only 53 92 15 H or HP combined with TKI 0 5 81 Naïve 43 0 0 ADCs 0 1 11 Tumor thrombus Yes 30 32 24 No 66 66 83 Multiple metastases <3 sites 65 60 44 ≥3 sites 31 38 63 Metastatic sites Visceral 60 71 88 Non-visceral 36 27 19 Trastuzumab resistance status Sensitivity 96 0 0 Resistance 0 98 107 TKI resistance status Sensitivity 96 73 18 Resistance 0 25 89 Conclusions IPyC regimen achieves durable disease control with manageable toxicity, offering a CNS-protective strategy. Legal entity responsible for the study The authors."

Metastases • Retrospective data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PGR

The necessity of adding anti-HER2 antibody to TKI in trastuzumab-resistant, HER2-positive ABC: A multicenter real-world study (ESMO 2025) - "Methods This real-world study consecutively enrolled HER2-positive ABC patients treated with TKI alone or combined with antibody (inetetamab/trastuzumab) at 3 institutions (including the National Cancer Center, China) from October 2014 to April 2024. Further studies are warranted to identify the population that may benefit from the antibody-combined therapy. Legal entity responsible for the study Chinese Academy of Medical Sciences and Peking Union Medical College - National Cancer Center, Cancer Hospital."

Clinical • Real-world • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

SHINE-HER: SKB264 Plus Inetetamab in HER2-Positive Metastatic Breast Cancer Patients Progressing After T-DXd Treatment (clinicaltrials.gov) - P2 | N=48 | Recruiting | Sponsor: Fudan University

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Real-world efficacy and safety of inetetamab-based therapy in HER2-positive metastatic breast cancer patients with prior exposure to trastuzumab. (PubMed, Front Oncol) - "The most common all-grade AEs were neutropenia (182/500, 36.4%) and leukopenia (157/500, 31.4%). Inetetamab was promising in HER2-positive MBC patients who had prior exposure to trastuzumab, offering a new option for patients with a prior failure of trastuzumab."

Journal • Real-world evidence • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Leukopenia • Neutropenia • Oncology • Solid Tumor • HER-2

The efficacy and safety of neoadjuvant Ineteramab, Pertuzumab, Toripalimab and Paclitaxel in Patients With Her2-Positive Breast Cancer (A Single-Center Clinical Trial) (ChiCTR) - P4 | N=47 | Not yet recruiting | Sponsor: Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center

New P4 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Real-world efficacy and safety of inetetamab-based therapy in HER2-positive metastatic breast cancer patients with prior exposure to trastuzumab (Frontiers) - "A multicenter retrospective study collected clinicopathological data from a total of 500 patients between Jul 2020 and Oct 2023...In the overall cohort, we observed a median PFS of 8.0 months, an ORR of 28.6% and a DCR of 89.2% (median treatment line: third line). Meanwhile, patients who received a combination treatment regime of inetetamab + tyrosine kinase inhibitors (TKIs) + chemotherapy achieved the most prolonged PFS of 9.0 months and the higher ORR of 29.3%. Ki67 index, distant lymph nodes metastasis and treatment strategy were independent predictors of PFS. The most common all-grade AEs were neutropenia (182/500, 36.4%) and leukopenia (157/500, 31.4%).Inetetamab was promising in HER2-positive MBC patients who had prior exposure to trastuzumab, offering a new option for patients with a prior failure of trastuzumab."

Real-world • Real-world evidence • HER2 Positive Breast Cancer

Inetetamab triggers cardiotoxicity through its interaction with apoptosis, oxidative stress and autophagy pathways. (PubMed, Sci Rep) - "Furthermore, Inetetamab administration significantly modulated the expression of apoptosis- and autophagy-related proteins both in vivo and in vitro. Our study highlights Inetetamab induces cardiotoxicity by affecting apoptosis, oxidative stress and autophagy."

Journal • Breast Cancer • Cardiovascular • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • NPPB • TNNI3

Efficacy and safety of inetetamab-containing regimens in patients with HER2-positive metastatic breast cancer in first-line/second-line setting. (PubMed, Front Oncol) - "Patients treated with first-line regimens benefited the most, with a median PFS of 15.0 versus (vs.) 10.0 months (first-line- vs. second-line inetetamab plus pyrotinib, p <0.001), 19.0 vs. 17.0 months (first-line- vs. second-line inetetamab plus pertuzumab, p=0.096), and 13.0 vs. not reached months (first-line- vs. second-line inetetamab plus chemotherapy, p=0.229). Diarrhea (39.2%), white blood cell count decreased (33.0%), and myelosuppression (18.6%) as the most frequent ones. Following the first- and second-line of treatment, inetetamab- containing combinations demonstrated promising clinical activity and a manageable safety profile in patients with HER2-positive MBC, especially in the first-line treatment."

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

Advancing Neoadjuvant Therapy with Inetetamab for HER2-Positive Breast Cancer. (PubMed, Cancer Lett) - "Although HER2-targeted therapies such as trastuzumab and pertuzumab result in significantly improved clinical outcomes, the total pathological complete response (tpCR) rate remains suboptimal, particularly among hormone receptor (HR)-positive patients [2]. In this issue of Cancer Letters, Zuo and colleagues present findings from a single-arm, multicenter phase II clinical trial investigating a neoadjuvant regimen combining inetetamab, pertuzumab, and nab-paclitaxel (TIP regimen) in patients with early-stage or locally advanced HER2-positive breast cancer [5]. Through comprehensive evaluation of both efficacy and safety, the study demonstrates exceptional therapeutic potential of the TIP regimen, with a high tpCR rate observed in estrogen receptor (ER)-negative patients, indicating particular promise for this subgroup of HER2-positive breast cancer."

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

Spatial discovery of pyrotinib overcoming HER2-positive breast cancer resistance by breaking fibroblast-induced immune barriers. (PubMed, Drug Resist Updat) - "Spatial organization of cellular interactions in the tumor microenvironment (TME) provides insights into prognosis beyond pathological subtypes. The role of NeoPICD in disruption of fibroblast barriers and enhancement of immune cell function suggests therapeutic advantages in overcoming resistance to anti-HER2 therapies. This research offers new strategies for precision treatment of locally advanced HER2-positive breast cancer."

Journal • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PD-L1

Exploration of neoadjuvant therapy regimens and prediction of immune effects for HER2-positive locally advanced breast cancer. (ASCO 2025) - P2 | "Phase II clinical trial included HER2-positive LABC patients (stages IIA-IIIC), who received 6-8 cycles of TCbIP (inetetamab combined with pertuzumab, paclitaxel, and carboplatin) regimen. In the NAT of HER2-positive breast cancer, the efficacy of inetetamab is comparable to trastuzumab. In vivo experiments confirm that the addition of immunotherapy can effectively reshape the immune environment and enhance systemic anti-tumor immune responses. The results of the clinical study further highlight the potential of inetetamab to improve therapeutic efficacy."

Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CD8 • HER-2

Efficacy and safety of inetetamab-containing regimens in patients with HER2-positive metastatic breast cancer in first-line/second-line setting (Frontiers) - "A total of 329 patients were enrolled and included in the efficacy analysis. The most frequently used treatment strategy was contained inetetamab plus pyrotinib (205/329, 62.3%). Patients treated with first-line regimens benefited the most, with a median PFS of 15.0 versus (vs.) 10.0 months (first-line- vs. second-line inetetamab plus pyrotinib, p <0.001), 19.0 vs. 17.0 months (first-line- vs. second-line inetetamab plus pertuzumab, p=0.096), and 13.0 vs. not reached months (first-line- vs. second-line inetetamab plus chemotherapy, p=0.229). The complete response (CR) was observed in 16 (4.9%) patients of all cohort, with the ORR was 51.1% (95% confidence interval [CI], 45.7%-56.4%), and the DCR was 96.4% (95% CI, 93.7%-97.9%). The grade 3 or higher adverse events (AEs) were observed in 29.5% of the whole study cohort. Diarrhea (39.2%), white blood cell count decreased (33.0%), and myelosuppression (18.6%) as the most frequent ones."

Retrospective data • HER2 Positive Breast Cancer

A Study on the Efficacy and Safety of IPyC for HER2+ MBC (clinicaltrials.gov) - P=N/A | N=301 | Completed | Sponsor: Fujian Medical University

New trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Efficacy and safety of inetetamab plus pertuzumab and nab-paclitaxel as neoadjuvant therapy for HER2+ breast cancer: A single-arm multicenter phase II clinical trial. (PubMed, Cancer Lett) - "The combination of inetetamab and vinorelbine has demonstrated survival benefits with an acceptable toxicity profile in HER2+ metastatic breast cancer (MBC) patients. No death occurred during the neoadjuvant treatment. Neoadjuvant treatment with inetetamab, in combination with pertuzumab and nab-paclitaxel, demonstrates good efficacy and tolerability, especially in ER-negative patients."

Journal • P2 data • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Infectious Disease • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • ER • HER-2

Efficacy and safety of inetetamab-based therapies in HER2-positive breast cancer: A systematic review and meta-analysis (ESMO-BC 2025) - "Inetetamab, a novel anti-HER2 monoclonal antibody, has shown promise as an alternative to trastuzumab, demonstrating comparable efficacy and safety in both neoadjuvant and metastatic settings. Inetetamab-based therapies demonstrate significant efficacy with a high CBR and ORR in HER2-positive breast cancer. While neutropenia and anemia are common adverse effects, their incidence is consistent with established HER2-targeted regimens. These findings support inetetamab as a viable therapeutic alternative, warranting further prospective validation to refine treatment protocols and enhance patient outcomes."

Retrospective data • Review • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Efficacy and Safety Study of Inetetamab and Pyrotinib Combined with Chemotherapy as First-Line Treatment for HER2-Expressing Advanced Cholangiocarcinoma (ChiCTR) - P4 | N=24 | Not yet recruiting | Sponsor: Beijing Chao-Yang Hospital, Capital Medical University; Beijing Chao-Yang Hospital, Capital Medical University

New P4 trial • Biliary Cancer • Cholangiocarcinoma • Gallbladder Cancer • Hepatology • Oncology • Solid Tumor

Confronting Barriers in HER2-Positive Metastatic Breast Cancer: Insights from a Phase II Trial of Inetetamab, Pyrotinib, and Chemotherapy (SG-BCC 2025) - P2 | "While HER2-targeted therapies like trastuzumab and pertuzumab have improved survival, resistance and brain metastases remain critical challenges. Inetetamab, pyrotinib, and chemotherapy demonstrated significant efficacy and good safety, offering a new therapeutic option for HER2-positive metastatic breast cancer after trastuzumab failure. The study identified potential biomarkers and molecular pathways for resistance and metastasis, supporting optimized patient selection and advancing personalized treatment strategies."

IO biomarker • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CAFs • HER-2 • PD-L2 • PLA2G2A • SLC2A3 • THY1

Comprehensive analysis of anti-HER2 antibodies-insensitive HER2-positive breast cancer patients in neoadjuvant therapy: a multi-center real-world study (SG-BCC 2025) - " This study consecutively included HER2-positive breast cancer patients who underwent NAT with chemotherapy and anti-HER2 monoclonal antibody (regimens including trastuzumab, trastuzumab plus pertuzumab or inetetamab plus pertuzumab) at National Cancer Center and two other hospitals from Jan 2017 to Dec 2023. HR positivity, HER2 2+/FISH+, and single-agent anti-HER2 therapy are associated with NAT-insensitivity. NAT-insensitive patients demonstrated poorer EFS. Further investigation is warranted to identify the underlying mechanisms."

Clinical • Real-world • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor