Rindopepimut
Rindopepimut (CDX-110) is an injectable peptide cancer vaccine[1] which targets a mutant protein called EGFRvIII present in about 25% to 30% of glioblastoma cases.[2]
The vaccine consists of the EGFRv3-specific peptide (a 13-amino acid mutant vIII epitope[3]) conjugated to the non-specific immunomodulator keyhole limpet hemocyanin (KLH).[4]
The US FDA granted it Breakthrough Therapy designation for glioblastoma in Feb 2015 meaning that it might be able to get approval sooner if it is effective.[5]
Clinical trials
[edit]Glioblastoma
[edit]The phase II ACT III study reported encouraging results in June 2015.[1]
The ReACT clinical trial for glioblastoma reported encouraging results in 2015.[2]
In March 2016 the phase III ACT IV trial [6] was terminated because it did not increase overall survival.[7]
References
[edit]- ^ a b Zussman; et al. (2015). "Outcomes of the ACT III Study: Rindopepimut (CDX-110) Therapy for Glioblastoma". Neurosurgery. 76 (6): N17. doi:10.1227/01.neu.0000465855.63458.0c. PMID 25985004.
- ^ a b Celldex Vaccine Rindopepimut Cuts Death Risk From Brain Cancer, Study Shows. WSJ Nov 2015
- ^ "FDA Grants Rindopepimut Breakthrough Designation for EGFRvIII-Positive Glioblastoma. Feb 2015". Archived from the original on 2016-05-05. Retrieved 2016-04-18.
- ^ rindopepimut definition
- ^ Khleif, Samir N.; Rixe, Olivier; Skeel, Roland (2016). Skeel's Handbook of Cancer Therapy. Lippincott Williams & Wilkins. ISBN 9781496353399.
- ^ Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma (ACT IV)
- ^ "Rindopepimut Misses OS Endpoint in Phase III Glioblastoma Trial. March 2016". Archived from the original on 2016-05-05. Retrieved 2016-04-18.
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