Rindopepimut Explained

Rindopepimut (CDX-110) is an injectable peptide cancer vaccine which targets a mutant protein called EGFRvIII present in about 25% to 30% of glioblastoma cases.

The vaccine consists of the EGFRv3-specific peptide (a 13-amino acid mutant vIII epitope^[1]) conjugated to the non-specific immunomodulator keyhole limpet hemocyanin (KLH).^[2]

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.^[3] __TOC__

Clinical trials

Glioblastoma

The phase II ACT III study reported encouraging results in June 2015.^[4]

The ReACT clinical trial for glioblastoma reported encouraging results in 2015.^[5]

In March 2016 the phase III ACT IV trial ^[6] was terminated because it did not increase overall survival.^[7]

Notes and References

1. Web site: FDA Grants Rindopepimut Breakthrough Designation for EGFRvIII-Positive Glioblastoma. Feb 2015 . 2016-04-18 . 2016-05-05 . https://web.archive.org/web/20160505191143/http://global.onclive.com/web-exclusives/FDA-Grants-Rindopepimut-Breakthrough-Designation-for-EGFRvIII-Positive-Glioblastoma . dead .
2. http://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=546970 rindopepimut definition
3. Book: Khleif . Samir N. . Rixe . Olivier . Skeel . Roland . Skeel's Handbook of Cancer Therapy . 2016 . Lippincott Williams & Wilkins . 9781496353399 . en.
4. Outcomes of the ACT III Study: Rindopepimut (CDX-110) Therapy for Glioblastoma. . Neurosurgery . 76 . 6 . N17 . 10.1227/01.neu.0000465855.63458.0c . 25985004 . Zussman . 2015 . etal. free .
5. https://www.wsj.com/articles/celldex-vaccine-rindopepimut-cuts-death-risk-from-brain-cancer-study-shows-1448058339 Celldex Vaccine Rindopepimut Cuts Death Risk From Brain Cancer, Study Shows. WSJ Nov 2015
6. https://clinicaltrials.gov/ct2/show/NCT01480479 Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma (ACT IV)
7. Web site: Rindopepimut Misses OS Endpoint in Phase III Glioblastoma Trial. March 2016 . 2016-04-18 . 2016-05-05 . https://web.archive.org/web/20160505231208/http://global.onclive.com/web-exclusives/rindopepimut-misses-os-endpoint-in-phase-iii-glioblastoma-trial . dead .