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    DRUG:

    TheraCIM (nimotuzumab)

    i
    Other names: DE-766, h-R3, OSAG101, anti-EGFR mAb hR3, DE 766, DE766, OSAG-101, OSAG 101
    Company:
    Biocon, Biotech Pharma, Daiichi Sankyo
    Drug class:
    EGFR inhibitor
    Related drugs:
    5d
    Induction chemotherapy plus PD-1 blockade and nimotuzumab for locoregionally advanced nasopharyngeal carcinoma: a propensity-matched retrospective study. (PubMed, Jpn J Clin Oncol)
    Adding PD-1 inhibitor plus nimotuzumab to induction chemotherapy improved early tumor shrinkage while maintaining an acceptable safety profile. These encouraging early data reinforce the need for ongoing prospective trials to confirm long-term benefit and to refine patient selection.
    Retrospective data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR expression
    |
    TheraCIM (nimotuzumab)
    7d
    Compare Radiotherapy Plus Nimotuzumab Versus Radiotherapy Alone in Platinum-ineligible Patients With Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P3, N=335, Recruiting, Shandong Cancer Hospital and Institute
    New P3 trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    TheraCIM (nimotuzumab)
    8d
    A Phase I Study of Nimotuzumab With Nivolumab in Advanced Non-small Cell Lung Cancer and Head and Neck Squamous Cell Cancer. (PubMed, Cureus)
    Asymptomatic troponin elevation was seen with this combination treatment. While there were no clinically significant adverse cardiac outcomes, further development was terminated due to the competitive landscape.
    P1 data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation
    |
    Opdivo (nivolumab) • TheraCIM (nimotuzumab)
    9d
    The efficacy of combination therapy versus monotherapy in patients with glioblastoma with abnormal epidermal growth factor receptor (EGFR) genes, a systematic review and network meta-analysis. (PubMed, Neuroscience)
    The analysis revealed that combination therapies generally demonstrated superior efficacy compared to the single ones, while monotherapies exhibited greater potency than temozolomide (TMZ). In terms of median progression-free survival (PFS), the combinations of Afatinib plus TMZ (SUCRA: 62.28%), rindopepimut (CDX-110) plus TMZ (SUCRA: 62.27%), and depatuxizumab mafodotin (Depatux M) plus TMZ (SUCRA: 54.4%) ranked among the top tier. For median overall survival (OS), the combinations of CDX-110 plus TMZ (SUCRA: 68.8%), Depatux M plus TMZ (SUCRA: 68.3%), and Nimotuzumab plus TMZ (SUCRA: 52.5%) were positioned in the upper echelon. In terms of prolonging both median PFS and median OS in GB, CDX-110 plus TMZ and Depatux M plus TMZ have shown slightly better than comparable therapies. However, further clinical trials are needed to confirm the effectiveness of other drugs in this respect.
    Retrospective data • Review • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    Gilotrif (afatinib) • temozolomide • TheraCIM (nimotuzumab) • depatuxizumab mafodotin (ABT-414) • Rintega (rindopepimut)
    10d
    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. (PubMed, J Gynecol Oncol)
    The current standard for treating locally advanced cervical cancer is cisplatin-based concurrent chemoradiotherapy (CCRT). Patient enrollment was started in April 2024 with an estimated completion date of April 2030. ClinicalTrials.gov Identifier: NCT06333821.
    Clinical • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    cisplatin • TheraCIM (nimotuzumab)
    19d
    Nimotuzumab,Camrelizumab, and Neoadjuvant Chemotherapy（nCT） in the Treatment of Esophageal Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=48, Enrolling by invitation, Peking University
    New P2 trial
    |
    cisplatin • AiRuiKa (camrelizumab) • albumin-bound paclitaxel • TheraCIM (nimotuzumab)
    20d
    Sintilimab-Nimotuzumab Induction Followed by Chemoradiation-Nimotuzumab in LA-HNSCC: Single-Arm Phase II (clinicaltrials.gov)
    P2, N=23, Not yet recruiting, Fujian Cancer Hospital
    New P2 trial
    |
    cisplatin • paclitaxel • Tyvyt (sintilimab) • TheraCIM (nimotuzumab)
    1m
    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, The First Affiliated Hospital with Nanjing Medical University
    New P2 trial
    |
    gemcitabine • albumin-bound paclitaxel • TheraCIM (nimotuzumab)
    1m
    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.
    Observational data • Retrospective data • Journal
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12D • KRAS G12
    |
    gemcitabine • TheraCIM (nimotuzumab)
    2ms
    HRS-4642 in Combination With Nimotuzumab and Chemotherapy for BRPC With KRAS G12D Mutation (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Zhejiang University
    New P2 trial
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    paclitaxel • TheraCIM (nimotuzumab) • HRS-4642
    2ms
    HRS-4642 Combined With Nimotuzumab in the Treatment of Recurrent or Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
    P1/2, N=20, Recruiting, West China Hospital | N=10 --> 20
    Enrollment change
    |
    TheraCIM (nimotuzumab) • HRS-4642