TheraCIM (nimotuzumab) / Daiichi Sankyo, Biocon, Biotech Pharma - LARVOL DELTA

NOTABLE-309: Nimotuzumab Combined With Nab-paclitaxel/Gemcitabine in the Perioperative Treatment of High-risk Resectable/Borderline Resectable Pancreatic Cancer (clinicaltrials.gov) - P2 | N=156 | Not yet recruiting | Sponsor: The First Affiliated Hospital with Nanjing Medical University

New P2 trial • Oncology • Pancreatic Cancer • Solid Tumor

Exploration of the efficacy of nimotuzumab combined with induction chemotherapy in locally advanced nasopharyngeal carcinoma: A multicenter, prospective phase III study (ESMO Asia 2025) - "This study aims to explore the efficacy and safety of nimotuzumab combined with induction chemotherapy in the treatment of LANPC. All patients received induction chemotherapy (docetaxel 75mg/m2 or gemcitabine 1000 mg/m2, iv, d1; cisplatin 25 mg/ m2 iv, d1-3, Q3W) combined with CCRT (cisplatin: 25 mg/m2, iv, d1-3, Q3W; IMRT/VMAT: d1-5, 5 fractions for a week). Nimotuzumab during the induction period achieved better ORR and had lower side effects caused by radiotherapy."

Clinical • Metastases • P3 data • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Efficacy and safety of liposomal irinotecan plus nimotuzumab in immune checkpoint inhibitor–refractory recurrent or metastatic nasopharyngeal carcinoma: A single-arm, open-label, phase II trial (ESMO Asia 2025) - P2 | "Liposomal irinotecan combined with nimotuzumab demonstrated meaningful clinical activity with favorable tolerability in immunotherapy-refractory RM-NPC. This regimen provides an important treatment alternative, particularly for patients who cannot tolerate high-intensity chemotherapy."

Checkpoint inhibition • Clinical • Metastases • P2 data • Esophageal Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

A prospective phase II study of stratified treatment of initially resectable locally advanced head and neck squamous carcinoma (LA HNSCC) based on pathological response after neoadjuvant chemoimmunotherapy (ESMO Asia 2025) - "All patients received albumin-bound paclitaxel 260mg/m2, cisplatin 75mg/m2, and tislelizumab 200 mg on day 1 of every 3-week cycle for 2-3 cycles...Patients who did not achieve MPR received standard IMRT, 60-66 Gy (2.0 Gy/f), 5 times per week for 6-6.5 weeks with concurrent nimotuzumab 200 mg, every week for 7 cycles), and sequential tislelizumab. The primary endpoint was the event-free survival (EFS) rate in 2 years. Secondary endpoints were the objective response rate and pCR rate."

Clinical • Metastases • P2 data • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A single-arm, multicenter, prospective phase II study of tislelizumab in combination with nimotuzumab and GP induction followed by IMRT and tislelizumab plus nimotuzumab for high-risk locally advanced nasopharyngeal carcinoma (Recent Data Updates) (ESMO Asia 2025) - P2 | "The induction therapy regimen includes tislelizumab (200 mg, every 3 weeks) + nimotuzumab (200 mg, weekly) + GP chemotherapy (Gemcitabine 1 g/m2 on Day 1 and Day 8, cisplatin 80 mg/m2 on Day 1-3), administered for a total of 3-4 cycles. Subsequently, IMRT combined with tislelizumab and nivolumab was adopted... The combination of tislelizumab and nimotuzumab, when added to GP induction chemotherapy, has demonstrated a promising complete response (CR) rate in high-risk LA-NPC."

Clinical • Combination therapy • Metastases • P2 data • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Lost in translation: Do preclinical studies predict clinical failure in GBM? (SNO 2025) - "For the trials evaluated, no preclinical brain:plasma (B/P) data were reported for enzastaurin, cilengitide, nimotuzumab, Depatux-M, or bevacizumab, although IgG typically has a B/P ≈1%...The best response for each drug compared to relevant control (relative increase in median survival) was 22% (nimotuzumab), 31% (marizomib), 36% (sunitinib CD) / 5% (sunitinib PD), 63% (bevacizumab/temozolomide), 140% (imatinib), 157% (Depatux-M), 220% (veliparib/temozolomide), 300% (cediranib); median survival was not reached for cilengitide...The stunning lack of clinical progress in GBM is deeply discouraging, but is consistent with underwhelming preclinical testing and the contextual interpretation of those results. Acknowledging multifaceted reasons for failed clinical trials, a more rigorous and critical approach should be used in preclinical studies, coupled with follow-up surgical window of opportunity studies, to identify and promote only the most promising therapies into..."

Preclinical • Brain Cancer • CNS Disorders • Glioblastoma • Solid Tumor

Lost in translation: Do preclinical studies predict clinical failure in GBM? (SNO 2025) - "For the trials evaluated, no preclinical brain:plasma (B/P) data were reported for enzastaurin, cilengitide, nimotuzumab, Depatux-M, or bevacizumab, although IgG typically has a B/P ≈1%...The best response for each drug compared to relevant control (relative increase in median survival) was 22% (nimotuzumab), 31% (marizomib), 36% (sunitinib CD) / 5% (sunitinib PD), 63% (bevacizumab/temozolomide), 140% (imatinib), 157% (Depatux-M), 220% (veliparib/temozolomide), 300% (cediranib); median survival was not reached for cilengitide...The stunning lack of clinical progress in GBM is deeply discouraging, but is consistent with underwhelming preclinical testing and the contextual interpretation of those results. Acknowledging multifaceted reasons for failed clinical trials, a more rigorous and critical approach should be used in preclinical studies, coupled with follow-up surgical window of opportunity studies, to identify and promote only the most promising therapies into..."

Preclinical • Brain Cancer • CNS Disorders • Glioblastoma • Solid Tumor

Lost in translation: Do preclinical studies predict clinical failure in GBM? (WFNOS 2025) - "For the trials evaluated, no preclinical brain:plasma (B/P) data were reported for enzastaurin, cilengitide, nimotuzumab, Depatux-M, or bevacizumab, although IgG typically has a B/P ≈1%...The best response for each drug compared to relevant control (relative increase in median survival) was 22% (nimotuzumab), 31% (marizomib), 36% (sunitinib CD) / 5% (sunitinib PD), 63% (bevacizumab/temozolomide), 140% (imatinib), 157% (Depatux-M), 220% (veliparib/temozolomide), 300% (cediranib); median survival was not reached for cilengitide...The stunning lack of clinical progress in GBM is deeply discouraging, but is consistent with underwhelming preclinical testing and the contextual interpretation of those results. Acknowledging multifaceted reasons for failed clinical trials, a more rigorous and critical approach should be used in preclinical studies, coupled with follow-up surgical window of opportunity studies, to identify and promote only the most promising therapies into..."

Preclinical • Brain Cancer • CNS Disorders • Glioblastoma • Oncology • Solid Tumor

Lost in translation: Do preclinical studies predict clinical failure in GBM? (WFNOS 2025) - "For the trials evaluated, no preclinical brain:plasma (B/P) data were reported for enzastaurin, cilengitide, nimotuzumab, Depatux-M, or bevacizumab, although IgG typically has a B/P ≈1%...The best response for each drug compared to relevant control (relative increase in median survival) was 22% (nimotuzumab), 31% (marizomib), 36% (sunitinib CD) / 5% (sunitinib PD), 63% (bevacizumab/temozolomide), 140% (imatinib), 157% (Depatux-M), 220% (veliparib/temozolomide), 300% (cediranib); median survival was not reached for cilengitide...The stunning lack of clinical progress in GBM is deeply discouraging, but is consistent with underwhelming preclinical testing and the contextual interpretation of those results. Acknowledging multifaceted reasons for failed clinical trials, a more rigorous and critical approach should be used in preclinical studies, coupled with follow-up surgical window of opportunity studies, to identify and promote only the most promising therapies into..."

Preclinical • Brain Cancer • CNS Disorders • Glioblastoma • Glioma • Oncology • Solid Tumor

Clinical study on induction chemotherapy combined with concurrent chemoradiotherapy for oropharyngeal squamous cell carcinoma (PubMed, Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi) - "The treatments included induction chemotherapy (IC)+concurrent chemoradiotherapy (CCRT)±epidermal growth factor receptor (EGFR) molecular targeted therapy, including 126 patients treated with EGFR molecular targeted drugs during CCRT (124 with nimotuzumab+2 with cetuximab) and 32 patients with PD-1 immunotherapy during induction chemotherapy. Non-surgical comprehensive therapy (IC+CCRT±EGFR inhibitors) is an effective treatment modality for advanced OPSSC, and patients can generally tolerate the associated adverse reactions. Moreover, p16+ patients exhibit a higher survival rate compared to p16- patients."

Journal • Mucositis • Oncology • Oropharyngeal Cancer • Otorhinolaryngology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Phase I Study of Nimotuzumab With Nivolumab in Advanced Non-small Cell Lung Cancer and Head and Neck Squamous Cell Cancer (Cureus) - "Four patients (57.1%) had Kirsten rat sarcoma (KRAS) mutation. All patients had disease progression after platinum-based and anti-PD1 therapy prior to enrollment, except for two NSCLC patients who were enrolled to receive this treatment after initial platinum-based chemotherapy only. Four patients (two from each dose level) had troponin elevation (median = 0.1 ng/ml, range = 0.07 to 0.3 ng/ml) lasting at least 24 hours, which normalized next week without any associated chest pain, except for one patient (HNSCC) with potential treatment-related DLT."

P1 data • Non Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck

NOTABLE-309: Nimotuzumab Combined With Nab-paclitaxel/Gemcitabine in the Perioperative Treatment of High-risk Resectable/Borderline Resectable Pancreatic Cancer (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Biotech Pharmaceutical Co., Ltd. | N=156 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Oncology • Pancreatic Cancer • Solid Tumor

Nimotuzumab Plus Gemcitabine-based Adjuvant Chemotherapy for Resectable Pancreatic Cancer: A Retrospective Observational Study. (PubMed, Pancreas) - "By adding nimotuzumab to existing gemcitabine-based AC regimens, RPC patients would show a survival benefit trend with a satisfactory safety profile."

Journal • Observational data • Retrospective data • Hematological Disorders • Leukopenia • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

Glioblastoma Treatment in Latin America: A Scoping Review. (SNO 2025) - "Therapeutic approaches varied widely, with frequent use of surgery (including sodium fluorescein and awake craniotomy), 3D/IMRT radiotherapy (RT), and temozolomide in concurrent/adjuvant settings...Some studies reported carmustine, bevacizumab, or nimotuzumab...Intraoperative fluorescein and total resection were also associated with longer OS (15 vs 8 months, p=0.002; 30.7 vs 13.6 months, p=0.02). This review reveals heterogeneity in treatment, limited standardization, and a need for regionally adapted guidelines and access to innovative therapeutic options, resource-appropiate protocols and equitable care."

Review • Addiction (Opioid and Alcohol) • Brain Cancer • Glioblastoma • Solid Tumor

Outcome of nimotuzumab use on newly diagnosed and recurrent malignant gliomas: a Philippine retrospective study on two tertiary institutions: (SNO 2025) - "Chart review was done for all glioma patients treated with nimotuzumab in combination with standard of care or with bevacizumab alone or metronomic temozolomide l from 2007-2022 in two institutions in the Philippines. There is an increased survival benefit in combining nimotuzumab with the current treatments available for malignant gliomas."

Retrospective data • Brain Cancer • Glioblastoma • Glioma • High Grade Glioma • Solid Tumor • EGFR

Should the Carbon Footprint of Care be Taken into Account When Choosing a Treatment for Lymphoma? a Case Application on Mantle Cell Lymphoma (ASH 2023) - "Namely, we compared 1) immunochemotherapy induction (rituximab, dexamethasone, cytarabine, and a platinum derivative) followed by autologous stem-cell transplantation and 3-year rituximab maintenance (LyMa) to obinituzumab, ibrutinib, venetoclax combination (OIV), and 2) rituximab, bendamustine combination (RB) to rituximab, ibrutinib combination (RI)...A larger fraction (10-70%) of the carbon footprint of biotherapies (rituximab, obinituzumab) and low-cost small molecules (cotrimoxazole, valaciclovir) is related to their production while it is smaller (<10%) for high-cost small molecules (ibrutinib, venetoclax) that require higher R&D, sales, general and administrative costs...Drug specific carbon accounting methods seem more adapted than nonspecific ones to estimate the carbon footprint of high cost drugs . Future research is required to determine more precisely the carbon footprint of drugs and therapeutic strategies in patients with hematological malignancies."

Clinical • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology

Multi-omics analysis reveals the role of tumor-infiltrating CD4+CCR7+ T cells in EGFR antibody resistance and prognosis of hepatocellular carcinoma. (PubMed, BMC Cancer) - No abstract available

Journal • Hepatocellular Cancer • Oncology • Solid Tumor • CCR7 • CD4

HRS-4642 Combined With Nimotuzumab in the Treatment of Recurrent or Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov) - P1/2 | N=20 | Recruiting | Sponsor: West China Hospital | N=10 ➔ 20

Enrollment change • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

HRS-4642 in Combination With Nimotuzumab and Chemotherapy for BRPC With KRAS G12D Mutation (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Zhejiang University

New P2 trial • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

Outcome of nimotuzumab use on newly diagnosed and recurrent malignant gliomas: a Philippine retrospective study on two tertiary institutions: (WFNOS 2025) - "Chart review was done for all glioma patients treated with nimotuzumab in combination with standard of care or with bevacizumab alone or metronomic temozolomide l from 2007-2022 in two institutions in the Philippines. There is an increased survival benefit in combining nimotuzumab with the current treatments available for malignant gliomas."

Retrospective data • Brain Cancer • Glioblastoma • Glioma • High Grade Glioma • Oncology • Solid Tumor • EGFR

Glioblastoma Treatment in Latin America: A Scoping Review. (WFNOS 2025) - P2 | "Therapeutic approaches varied widely, with frequent use of surgery (including sodium fluorescein and awake craniotomy), 3D/IMRT radiotherapy (RT), and temozolomide in concurrent/adjuvant settings...Some studies reported carmustine, bevacizumab, or nimotuzumab...Intraoperative fluorescein and total resection were also associated with longer OS (15 vs 8 months, p=0.002; 30.7 vs 13.6 months, p=0.02). This review reveals heterogeneity in treatment, limited standardization, and a need for regionally adapted guidelines and access to innovative therapeutic options, resource-appropiate protocols and equitable care."

Review • Addiction (Opioid and Alcohol) • Brain Cancer • Glioblastoma • Solid Tumor

EBV-positive small cell neuroendocrine carcinoma of the nasopharynx with cervical lymph node metastasis: a case report and literature review. (PubMed, Front Oncol) - "The patient received two cycles of etoposide-cisplatin induction chemotherapy and one cycle of targeted therapy (nimotuzumab) combined with radical radiotherapy(intensity-modulated radiation therapy, IMRT) to the nasopharyngeal and cervical lymph node regions. Epstein-Barr virus-positive nasopharyngeal small cell neuroendocrine carcinoma is an extremely rare head and neck malignancy. Identification of this rare tumor is crucial for disease management and patient prognosis."

Journal • Endocrine Cancer • Epstein-Barr Virus Infections • Head and Neck Cancer • Nasopharyngeal Carcinoma • Neuroendocrine Carcinoma • Oncology • Solid Tumor

Comparative in-Vitro Efficacy of CD20xCD3 IgG Bispecific Biosimilar Constructs Against Diffuse Large B Cell Lymphoma (DLBCL) Cell Lines with Different Levels of Expression of CD20 (ASH 2024) - "Using biosimilar versions of glofitamab, epcoritamab, odronextamab and mosunetuzumab we compared head-to-head the in vitro activity of these constructs against a panel of DLBCL cell lines expressing variable levels of cell surface CD20.MethodsBsAb activity was assessed using a flow cytometry-based cytotoxicity assay...UoL-RAD and SU-DHL-10 were sensitive to obinituzumab (EC50 95pM and 99pM respectively), and UoL-RAD alone sensitive to rituximab (EC50 1437pM). Rituximab and obinutuzumab did not engage T cells, but induced activation and degranulation of NK cells.ConclusionsThese data indicate that CD20 monospecific and BsAbs may have variable effects on CD20+ B cell malignancies, independent of levels of cell surface expression of CD20...These data may have important clinical sequencing considerations as CD19 and CD20 antigen loss is reported as a result of selective pressure after CD19 and CD20 targeted T cell redirecting therapy. The biological basis of inherent..."

Preclinical • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CD69 • IL2RA • LAMP1

Nimotuzumab plus image-guided radiotherapy for elderly patients with locally advanced cervical squamous cell carcinoma: Interim analysis of a prospective multi-center phase Ⅱ trial. (PubMed, Int J Radiat Oncol Biol Phys) - "Among elderly LACSCC patients, nimotuzumab plus image-guided radiotherapy and brachytherapy was well tolerated and indicated promising clinical survival benefits. The robustness of efficacy and toxicity results might provide a novel treatment option for this population."

Journal • Cervical Cancer • Cervical Squamous Cell Carcinoma • Hematological Disorders • Leukopenia • Neutropenia • Oncology • Solid Tumor • Squamous Cell Carcinoma • EGFR

A Single-Arm, Prospective, Multi-Center Study on the Treatment of Unresectable Locally Advanced/Oligometastatic Pancreatic Cancer Using Iodine-125 Radioactive Particle Implantation Combined with Nimotuzumab and Chemotherapy (ChiCTR) - P4 | N=58 | Not yet recruiting | Sponsor: Qilu Hospital of Shandong University (Qingdao); Qilu Hospital of Shandong University (Qingdao)

New P4 trial • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CA 19-9