Biology: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
Glioblastoma
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
- ↑ 1.0 1.1 Zussman (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.
- ↑ 2.0 2.1 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". http://global.onclive.com/web-exclusives/FDA-Grants-Rindopepimut-Breakthrough-Designation-for-EGFRvIII-Positive-Glioblastoma.
- ↑ rindopepimut definition
- ↑ Khleif, Samir N.; Rixe, Olivier; Skeel, Roland (2016) (in en). Skeel's Handbook of Cancer Therapy. Lippincott Williams & Wilkins. ISBN 9781496353399. https://books.google.com/books?id=NCzfCwAAQBAJ&pg=PT464.
- ↑ 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". http://global.onclive.com/web-exclusives/rindopepimut-misses-os-endpoint-in-phase-iii-glioblastoma-trial.
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