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DRUG:

Stimuvax (tecemotide)

i
Other names: ONO-7165 , EMD 531444, BLP25 liposomal vaccine, L BLP25, L-BLP25
Associations
Company:
EMD Serono, Ono Pharma, Pfizer
Drug class:
Immunostimulant, MUC1 inhibitor
Related drugs:
Associations
1m
Monocyte subsets in breast cancer patients under treatment with aromatase inhibitor and mucin-1 cancer vaccine. (PubMed, J Transl Med)
This study identified classical monocytes to be associated with ER positive BC and with patient response to neoadjuvant endocrine treatment and cancer vaccination.
Journal
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ER (Estrogen receptor) • MUC1 (Mucin 1)
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ER positive
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letrozole • Stimuvax (tecemotide)
almost3years
Immunotherapy (excluding checkpoint inhibitors) for stage I to III non-small cell lung cancer treated with surgery or radiotherapy with curative intent. (PubMed, Cochrane Database Syst Rev)
The immunological interventions were active immunotherapy Bacillus Calmette-Guérin (BCG) adoptive cell transfer (i.e. transfer factor (TF), tumour-infiltrating lymphocytes (TIL), dendritic cell/cytokine-induced killer (DC/CIK), antigen-specific cancer vaccines (melanoma-associated antigen 3 (MAGE-A3) and L-BLP25), and targeted natural killer (NK) cells...Two trials provided health-related quality of life results with contradicting results.  AUTHORS' Based on this updated review, the current literature does not provide evidence that suggests a survival benefit from adding immunotherapy (excluding checkpoint inhibitors) to conventional curative surgery or radiotherapy, for people with localised NSCLC (stages I to III). Several ongoing trials with immune checkpoints inhibitors (PD-1/PD-L1) might bring new insights into the role of immunotherapy for people with stages I to III NSCLC.
Review • Journal • Checkpoint inhibition
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MAGEA3 (MAGE Family Member A3)
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Stimuvax (tecemotide)
over3years
Conventional versus reverse sequence of neoadjuvant epirubicin/cyclophosphamide and docetaxel: sequencing results from ABCSG-34. (PubMed, Br J Cancer)
Upfront docetaxel did not improve chemotherapy activity or tolerability; these results suggest that upfront neoadjuvant treatment with anthracyclines remains a valid option.
Clinical • Journal
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HER-2 (Human epidermal growth factor receptor 2) • MUC1 (Mucin 1)
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HER-2 negative
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docetaxel • epirubicin • Stimuvax (tecemotide)
almost4years
[VIRTUAL] Immunotherapy as a second-line or later treatment modality for advanced non-small cell lung cancer: A review of safety and efficacy (ASHP 2020)
The eligible trials studied the following therapies: nivolumab (3 trials), pembrolizumab (1 trial), durvalumab (2 trials), atezolizumab (2 trials), avelumab (1 trial), PPV (3 trials), and tecemotide (2 trials). Recent evidence shows durability and limited toxicity of immune-based therapies in the treatment of advanced NSCLC. The majority of research has identified PD-1/PD-L1 immune-checkpoint inhibitors exhibiting favorable toxicity when compared to standard treatment. These modalities have also shown efficacy in NSCLC patients who have failed first-line treatment.
Clinical • Review
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MUC1 (Mucin 1)
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Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • Bavencio (avelumab) • Stimuvax (tecemotide)
4years
Clinical • P2 data • Journal
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • MUC1 (Mucin 1)
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MUC1 overexpression • TILs
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docetaxel • letrozole • epirubicin • Stimuvax (tecemotide) • cyclophosphamide intravenous
4years
Adjuvant MUC vaccination with tecemotide after resection of colorectal liver metastases: a randomized, double-blind, placebo-controlled, multicenter AIO phase II trial (LICC). (PubMed, Oncoimmunology)
Resection of colorectal liver metastases (CRLM) is a potential curative treatment for patients with metastatic colorectal cancer (mCRC) with liver-limited disease (LLD). MUC1 expression was not associated with outcome.EudraCT No: 2011-000218-20Clinical Trial Information: NCT01462513Financial Support: Merck KGaA, Darmstadt, Germany. AE: adverse event; CP: cyclophosphamide; CRC: colorectal cancer; CT: computed tomography; ECOG: Eastern Cooperative Oncology Group; FU: follow-up; HR: hazard ratio; IHC: immunohistochemical staining; ITT: intention-to-treat; DSMB: Data Safety Monitoring Board; LLD: liver-limited disease; mCRC: metastatic colorectal cancer; MPLA: monophosphoryl lipid; AMRI: magnetic resonance imaging; MUC1: mucin 1; NA: not applicable; NCI-CTCAE: National Cancer Institute Common Terminology Criteria for Adverse Events; NS: normal saline; NSCLC: non-small-cell lung carcinoma; OS: overall surviva; lPP: per protocol; RAS: Rat sarcoma; RFS: recurrence-free survival; TEAE: treatment-emergent adverse event; UICC: Union for International Cancer Control; US: ultrasound; vs.: versus.
Clinical • P2 data • Journal
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MUC1 (Mucin 1)
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Stimuvax (tecemotide) • cyclophosphamide intravenous
4years
Phase II Study of Immunotherapy With Tecemotide and Bevacizumab After Chemoradiation in Patients With Unresectable Stage III Non-Squamous Non-Small-Cell Lung Cancer (NS-NSCLC): A Trial of the ECOG-ACRIN Cancer Research Group (E6508). (PubMed, Clin Lung Cancer)
This cooperative group trial met its endpoint, demonstrating tolerability of bevacizumab + tecemotide after CRT and consolidation. In this selected group of patients, the median progression-free survival and overall survival are encouraging. Given that consolidation immunotherapy is now a standard of care following CRT in patients with LA-NSCLC, these results support a role for continued investigation of antiangiogenic and immunotherapy combinations in LA-NSCLC.
Clinical • P2 data • Journal
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MUC1 (Mucin 1)
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Avastin (bevacizumab) • carboplatin • paclitaxel • Stimuvax (tecemotide)