Peptide
Mifamurtide (Mepact)
Mifamurtide is a synthetic muramyl tripeptide immunomodulator for osteosarcoma. EMA-approved March 2009 (FDA denied 2007). Phase 3 INT-0133 (n=662): 6-year overall survival 78% vs 70% with chemotherapy alone. 28% relative reduction in death risk (HR 0.72, P=0.031). Indicated for high-grade, non-metastatic, resectable osteosarcoma ages 2-30 combined with post-operative chemotherapy. First immunotherapy approved for osteosarcoma. LIMITATIONS: Not FDA-approved; EMA approval based on single trial with statistical controversies.
- Updated
- How we grade
- 38 studies cited
Research notice. This page is for education and research. Peptides may not be FDA-approved for human use and may only be legally available for research. Talk to a qualified clinician before considering any peptide.
- Best evidence
- Grade A
- Conditions studied
- 1
- Outcomes
- 10
- Graded outcomes
- 1423
Evidence by condition
- Strong
- Moderate
- Limited
- Very limited
General
Key findings
- Flu-like SymptomsChanges; see studies
- Anti-Cancer ActivityImproves (the measure goes up)
- Immune FunctionImproves (the measure goes up)
Safety notes in the studies
- Relative risk reduction 28% (HR 0.72; 95% CI 0.53-0.97; P=0.031).
- Represents one-third reduction in death risk.
- Significant interaction between mifamurtide and ifosfamide identified.
Studies cited
38 studies from PubMed
- Tumor Immune Microenvironment-Associated Prognostic and Mifamurtide-Response Gene Signatures for Localized Osteosarcoma: A Correlative Study of the ISG/OS-2 Trial.
- The benefits of combining an immunomodulator with a chemotherapy agent in chondrosarcoma-a proof of concept with mifamurtide.
- Long-Circulating and Targeted Liposomes Co-loading Cisplatin and Mifamurtide: Formulation and Delivery in Osteosarcoma Cells.
- Microbe-mediated intestinal NOD2 stimulation improves linear growth of undernourished infant mice.
- The addition of the immunomodulator mifamurtide to adjuvant chemotherapy for early osteosarcoma: a retrospective analysis.
- Mucosal Adjuvants Delivered by a Mucoadhesive Patch for Sublingual Administration of Subunit Vaccines.
- Gut microbial DL-endopeptidase alleviates Crohn's disease via the NOD2 pathway.
- Phase 2 study for nonmetastatic extremity high-grade osteosarcoma in pediatric and adolescent and young adult patients with a risk-adapted strategy based on ABCB1/P-glycoprotein expression: An Italian Sarcoma Group trial (ISG/OS-2).
- Strategies for Using Muramyl Peptides - Modulators of Innate Immunity of Bacterial Origin - in Medicine.
- The perplexing role of immuno-oncology drugs in osteosarcoma.
- Improved osteosarcoma survival with addition of mifamurtide to conventional chemotherapy - Observational prospective single institution analysis.
- Delivery strategies for macromolecular drugs in cancer therapy.
- Harnessing the untapped potential of nucleotide-binding oligomerization domain ligands for cancer immunotherapy.
- Incorporating individual historical controls and aggregate treatment effect estimates into a Bayesian survival trial: a simulation study.
- Liposomal Formulations to Modulate the Tumour Microenvironment and Antitumour Immune Response.
- The Efficiency and Toxicity of Mifamurtide in Childhood Osteosarcoma.
- The Role of Mifamurtide in Chemotherapy-induced Osteoporosis of Children with Osteosarcoma.
- Osteogenic Sarcoma: Systemic Chemotherapy Options for Localized Disease.
- Immune Therapy for Sarcomas.
- Characteristics and outcomes of patients with advanced sarcoma enrolled in early phase immunotherapy trials.
- Effectiveness of mifamurtide in addition to standard chemotherapy for high-grade osteosarcoma: a systematic review.
- Osteosarcoma After Hematopoietic Stem Cell Transplantation in Children and Adolescents: Case Report and Review of the Literature.
- Lifetime effectiveness of mifamurtide addition to chemotherapy in nonmetastatic and metastatic osteosarcoma: a Markov process model analysis.
- Review and comparison of clinical evidence submitted to support European Medicines Agency market authorization of orphan-designated oncological treatments.
- An update on chemotherapy for osteosarcoma.
- The addition of mifamurtide to chemotherapy improves lifetime effectiveness in children with osteosarcoma: a Markov model analysis.
- Mifamurtide in metastatic and recurrent osteosarcoma: a patient access study with pharmacokinetic, pharmacodynamic, and safety assessments.
- Pharmacokinetics and pharmacodynamics of liposomal mifamurtide in adult volunteers with mild or moderate hepatic impairment.
- Osteosarcoma treatment - where do we stand? A state of the art review.
- Review of mifamurtide in the treatment of patients with osteosarcoma
- Mifamurtide: a review of its use in the treatment of osteosarcoma
- Mifamurtide in osteosarcoma--a practical review.
- Osteosarcoma: the addition of muramyl tripeptide to chemotherapy improves overall survival--a report from the Children's Oncology Group
- Gateways to clinical trials.
- Liposomal muramyl tripeptide phosphatidyl ethanolamine: ifosfamide-containing chemotherapy in osteosarcoma.
- Systemic targeting of liposome-encapsulated immunomodulators to macrophages for treatment of cancer metastasis.
- Osteosarcoma and other cancers of bone.
- Biological response modifiers in cancer therapeutics: potentialities and limitations.