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

Long-Term Survival and Biomarker-Based Exploratory Analysis of Nimotuzumab Combined with SIB-IMRT in Locally Advanced Esophageal Cancer: Insights from a Phase II Clinical Trial (ASTRO 2026) - P=N/A | "The updated survival outcomes showed promising efficacy of nimotuzumab plus SIB-IMRT in locally advanced ESCC. Persistent positivity for TP53 mutation after treatment may indicate a poorer prognosis and nucleosome positioning was a promising biomarker worthy of further exploration."

Biomarker • Clinical • Metastases • P2 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma • EGFR • TP53

Efficacy and safety of radiotherapy in combination with S-1 and nimotuzumab in elderly patients with esophageal cancer: a prospective single-arm study (ESMO 2026) - No abstract available

Clinical • Combination therapy • Esophageal Cancer • Oncology

Nimotuzumab Plus Concurrent Chemoradiotherapy Sequential Maintenance Treatment for Locally Advanced Cervical Squamous Cell Carcinoma (NOTABLE-306): A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial (ASTRO 2026) - P3 | "Purpose/Objective(s): The current standard for treating locally advanced cervical cancer is cisplatin-based concurrent chemoradiotherapy (CCRT). Not applicable"

Clinical • Metastases • Cervical Cancer • Cervical Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma • EGFR

Tislelizumab Combined with Nimotuzumab and Chemotherapy without Concurrent Cisplatin for Local Advanced Nasopharyngeal Carcinoma (ASTRO 2026) - "Materials/ Patients with III-IVa (AJCC 8th edition) NPC were recruited to receive tislelizumab and nimotuzumab plus taxanes-nedaplatin induction chemotherapy and concurrent tislelizumab plus nimotuzumab-radiotherapy (platin-free). Removing concurrent cisplatin and adding tislelizumab and nimotuzumab provides better response and lower toxicity for patients with LANPC."

Metastases • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Prospective Phase II Single-Arm Multicenter Study of Nimotuzumab plus Benmelstobart and Platinum-Based Doublet Neoadjuvant Therapy for Locally Advanced Head and Neck Squamous Cell Carcinoma (ASTRO 2026) - "In patients with locally advanced HNSCC, nimotuzumab plus benmelstobart and platinum-based doublet neoadjuvant therapy demonstrated an excellent ORR (100%) in these cases. Adverse events linked to treatment were predictable and under control, indicating the need for more research."

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

Safety and Feasibility of Nimotuzumab Combined with Gemcitabine and SABR-Boosted Concurrent Radiotherapy for Muscle Invasive Bladder Cancer: Initial Results from a Phase I/II Trial (ASTRO 2026) - P1 | "The combination of Nimotuzumab and low-dose Gemcitabine with concurrent radiotherapy demonstrated a manageable safety profile in this initial cohort. The regimen showed limited mucocutaneous toxicity and controlled hematologic events without febrile neutropenia. These preliminary findings support the continued accrual of this trial to further evaluate efficacy and safety."

Clinical • P1/2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Efficacy and Safety of an Adaptive Treatment Strategy for Locoregionally Advanced Nasopharyngeal Carcinoma Based on Response Stratification to Nimotuzumab Plus Induction Chemotherapy: A Prospective Multicenter Phase II Clinical Study (ASTRO 2026) - P2 | "All patients received three cycles of IC with NTZ, gemcitabine, and nedaplatin. A response-adapted strategy based on NTZ plus IC allows safe de-escalation of concurrent therapy during radiotherapy in good responders without compromising survival outcomes, supporting personalized treatment for LA-NPC and warranting validation in phase III trials. (Registration No. ChiCTR2000041139)."

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

Nimotuzumab Combined with Chemoradiotherapy vs. Chemoradiotherapy Alone in Advanced Esophageal Cancer: A Systematic Review and Meta-Analysis of Survival and Safety Outcomes (ASTRO 2026) - "Prespecified subgroup analyses were conducted by chemotherapy regimen (paclitaxel plus cisplatin [TP] versus fluorouracil plus cisplatin [FP]) and clinical stage (locally advanced). For locally advanced and metastatic esophageal cancer, the addition of nimotuzumab to chemoradiotherapy improved short term efficacy and overall survival without a significant increase in treatment related toxicity."

Metastases • Retrospective data • Review • Esophageal Cancer • Oncology • Squamous Cell Carcinoma

Nimotuzumab plus standard adjuvant chemotherapy after curative resection for pancreatic cancer: preliminary results of a prospective single-arm, two-cohort phase II study (ESMO 2026) - No abstract available

Clinical • P2 data • Oncology • Pancreatic Cancer • Solid Tumor

A Phase Ib/II Study of HRS-4642 plus Nimotuzumab in Patients with KRAS G12D-Mutant Advanced Pancreatic Ductal Adenocarcinoma (ESMO 2026) - No abstract available

Clinical • Metastases • P1/2 data • Oncology • Pancreatic Ductal Adenocarcinoma • KRAS

3-year survival outcomes of image-guided radiotherapy combined with nimotuzumab for elderly patients with locally advanced cervical squamous cell carcinoma: a multi-center phase 2 trial (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Cervical Cancer • Cervical Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Neoadjuvant toripalimab plus nimotuzumab combined with taxol-based chemotherapy in locally advanced penile squamous cell carcinoma: Five-year survival update of the phase II TNT trial (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Oncology • Penile Cancer • Squamous Cell Carcinoma

Mechanism-guided radiosensitization strategies for nasopharyngeal carcinoma: Current evidence and translational perspectives (Review). (PubMed, Oncol Lett) - "In selected patients with locoregionally advanced disease and a suboptimal response to induction chemotherapy, the addition of nimotuzumab to CCRT did not improve 2-year progression-free survival (81.0 vs. 80.8%; hazard ratio=0.93). By contrast, tislelizumab combined with chemotherapy markedly improved progression-free survival in recurrent or metastatic disease (hazard ratio=0.52), highlighting that systemic efficacy in this setting should not be conflated with radiosensitization during definitive radiotherapy...Key challenges include heterogeneous evidence quality, uncertain treatment sequencing and overlapping toxicities. Future treatment intensification should be biomarker-informed and tailored to disease stage, patient fitness and therapeutic index."

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

Neoadjuvant chemoradiation with camrelizumab and nimotuzumab for initially inoperable esophageal squamous cell carcinoma: A single-arm phase 2 trial. (PubMed, Eur J Cancer) - P2 | "NCRCN regimen was a promising treatment strategy with a high surgical conversion rate in initially inoperable patients with LAESCC. TRIAL REGISTRATION CLINICALTRIALS."

Journal • P2 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Disorder • Hematological Disorders • Neutropenia • Oncology • Squamous Cell Carcinoma • CD8 • FOXP3

Camrelizumab plus nimotuzumab as second-line therapy for advanced esophageal squamous cell carcinoma: a multicenter phase II study. (PubMed, J Immunother Cancer) - P2 | "Camrelizumab combined with nimotuzumab demonstrated encouraging antitumor activity and a manageable safety profile as second-line therapy for advanced ESCC."

IO biomarker • Journal • P2 data • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma • MTAP • MUC16 • NOTCH3

High-grade gliomas H3G34-mutant in pediatric and AYA population: a single center experience (EANO 2026) - "First-line chemotherapy included Nimotuzumab/Vinorelbine regimen (NV) (3/12), NV plus Temozolomide (TMZ) (4/12), TMZ alone (3/12), and TMZ plus Bevacizumab (1/12).Best response included partial response in 3/12 and stable disease in 1/12...At progression, one patient received re-irradiation and NV; 4/8 received second-line strategies, including TMZ plus Regorafenib (1/4), TMZ plus sirolimus (1/4), Nivolumab (1/4) and Bevacizumab (1/4), with limited impact on long-term outcomes... Although limited in size, this case series underscores the poor prognosis of HGG G34 in pediatric and young adult patients, characterized by infiltrative growth, restricted surgical resectability, and suboptimal response to current treatment modalities. These findings highlight the urgent need for the development of novel therapeutic strategies and more effective molecularly targeted approaches to address this rare yet highly aggressive malignancy."

Clinical • Brain Cancer • Glioma • High Grade Glioma • Oncology • Solid Tumor • CHEK2 • MSH3 • NBN • POLD1

Phase III trial of adjuvant nimotuzumab plus cisplatin-based chemoradiotherapy in resected stage III/IV head and neck squamous cell carcinoma (ESMO 2025) - P3 | "Weekly cisplatin had lower toxicity than 3-weekly regimens without compromising efficacy. Investigator-initiated multi-centre trials such as this demonstrate the potential of assembling institutions beyond existing cooperative groups, using well-established independent QA systems in place."

Clinical • P3 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR

Nimotuzumab plus concurrent chemoradiotherapy for locally advanced cervical squamous cell carcinoma: The randomized, phase 3 CC3 study. (ASCO 2024) - P=N/A | " All patients with locally advanced cervical squamous cell carcinoma were randomized (1:1) to receive nimotuzumab (400mg, iv, weekly, for 6 weeks) combined with CCRT (cisplatin: 40 mg/m 2 , weekly, for 6 weeks; IMRT/VMAT: 45-50.4 Gy/25-28f; high-dose rate brachytherapy: 30-40 Gy, in 8 weeks) or CCRT alone. Nimotuzumab combined with CCRT showed significant ORR improvement, longer trend in PFS and good safety in the treatment of LACC patients."

Clinical • Metastases • P3 data • Cervical Cancer • Oncology • Squamous Cell Carcinoma • EGFR

Nimotuzumab combined with gemcitabine versus gemcitabine in K-RAS wild-type locally advanced or metastatic pancreatic cancer: A prospective, randomized-controlled, double-blinded, multicenter, and phase III clinical trial. (ASCO 2022) - "Nimotuzumab combined with gemcitabine increases OS and PFS in patients with K-Ras wild-type locally advanced or metastatic pancreatic cancer, particularly for those without treatment of biliary obstruction. The safety profile of nimotuzumab is similar to placebo."

Clinical • Late-breaking abstract • P3 data • Gastrointestinal Cancer • Hematological Disorders • Hepatology • Leukopenia • Neutropenia • Oncology • Pancreatic Cancer • Solid Tumor • Thrombocytopenia • KRAS

Nimotuzumab Plus Gemcitabine for K-Ras Wild-Type Locally Advanced or Metastatic Pancreatic Cancer. (PubMed, J Clin Oncol) - P3 | "In patients with locally advanced or metastatic K-Ras wild-type PC, nimotuzumab plus gemcitabine significantly improved OS and PFS with a good safety profile."

Journal • Metastases • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • KRAS • RAS

Neoadjuvant toripalimab plus nimotuzumab combined with taxol-based chemotherapy in locally advanced penile squamous cell carcinoma. (PubMed, Cancer Cell) - P2 | "Biomarker analysis identified PD-L1 expression, TP53 mutation status, and CD8+ T cell density as potential predictive markers. Therefore, neoadjuvant TNT shows promising anti-tumor activity and acceptable toxicity."

IO biomarker • Journal • Oncology • Penile Cancer • Squamous Cell Carcinoma • CD8 • PD-L1 • TP53

Nimotuzumab plus concurrent chemo-radiotherapy versus chemo-radiotherapy in unresectable locally advanced esophageal squamous cell carcinoma (ESCC): Interim analysis from a prospective, randomized-controlled, double-blinded, multicenter, and phase III clinical trial (NXCEL1311 Study). (ASCO 2022) - " Unresectable locally advanced ESCC patients were randomized (1:1) to receive Nimo (400 mg, qw) or placebo in combination with concurrent chemo-radiotherapy (paclitaxel+ cisplatin+3DCRT/IMRT) for seven weeks. This interim analysis showed that nimotuzumab in combination with chemo-radiotherapy is safe and can increase the CRR and ORR of the treated patients. The OS needs to be followed and finally analyzed."

Clinical • P3 data • P3 data: top line • Agranulocytosis • Anemia • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Granulocytopenia • Hematological Disorders • Immunology • Inflammation • Leukopenia • Oncology • Squamous Cell Carcinoma • Thrombocytopenia

Nimotuzumab combined with paclitaxel and cisplatin as first-line treatment for metastatic esophageal squamous cell carcinoma: A prospective, multicenter, double-blind, randomized controlled clinical study. (ASCO 2026) - "Such as traditional two drugs chemotherapy (5-Fluorouracil and Cisplatin) as first-line treatment for metastatic and recurrent ESCC has an efficacy of 25-35%. In patients with metastatic EGFR gene amplification ESCC, nimotuzumab plus TP as first-line treatment significantly improved OS and PFS with a good safety profile."

Clinical • Metastases • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Prospective, Single-Arm, Phase Ⅱ Clinical Study of Nimotuzumab Combined with Chemotherapy as Neoadjuvant Therapy in Patients with Locally Advanced Head and Neck Squamous Cell Carcinoma (ChiCTR) - P2 | N=42 | Not yet recruiting | Sponsor: Department of Oncology, the Sixth Medical Center of PLA General Hospital, Beijing, China; Department of Oncology, the Sixth Medical Center of PLA Gene

New P2 trial • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR

NCRHNC: Nimotuzumab Plus Radiotherapy in Elderly Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=46 | Not yet recruiting | Sponsor: Ke Hu

New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR