DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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http://clinicaltrials.gov/ct2/show/NCT01480479
MAR 2013
Rindopepimut
Immunotherapeutic vaccine called Rindopepimut showed positive results in prolonging survival in patients with newly diagnosed EGFRvIII-positive glioblastoma (GB), one of the most aggressive forms of brain cancer
Celldex Therapeutics’ brain cancer vaccine, rindopepimut, also known as CDX-110, targets EGFRvIII, an activated mutation of the epidermal growth factor receptor (EGFR). This mutation is found in about 31% of cases of glioblastoma multiforme, a form of fast-growing brain cancer and the most common type of primary brain tumor. It can contribute to tumor growth, and is linked with poor long-term survival. It is not seen in normal tissue.
In the ACT III Phase II trial, which involved people with newly diagnosed EGFRvIII-positive glioblastoma, 65 patients were given rindopepimut in combination with standard-of-care treatment (temozolomide), after having undergone surgery and standard chemotherapy and radiation therapy.
focus on is Rindopepimut, an immunotherapy treatment that targets EGFRvIII. As it’s not found at significant levels in normal tissues but expressed in 30ish% of primary glioblastoma, it’s an ideal target that has produced promising results to date. The drug candidate has shown consistent benefit for patients across three phase 2 studies- that’s no fluke! It’s currently in a global phase 3 trial in patients with newly diagnosed glioblastoma with results due in a couple years
| Phase 3 Study of Rindopepimut in Patients With Newly Diagnosed Glioblastoma (ACT IV) | |
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| Design: | Phase 3, double-blind, study of rindopepimut compared with KLH control |
| Status: | Currently enrolling at multiple centers in the US; additional centers outside the US planned to be activated in 2012 |
ABOUT THE CLINICAL TRIAL
This 2-arm, randomized, Phase 3 study will investigate the efficacy and safety of the addition of rindopepimut to the current standard of care, temozolomide, in patients with recently diagnosed EGFRvIII positive glioblastoma. All patients will be administered temozolomide. Half the patients will be randomly assigned to receive rindopepimut (given along with GM-CSF as a vaccine adjuvant) and half the patients will be randomly assigned to receive a keyhole limpet hemocyanin (KLH). Patients will be treated in a blinded fashion (neither the patient nor the doctor will know which arm of the study the patient is on). Patients will be treated until disease progression or intolerance to therapy and all patients will be followed for survival.
All patients enrolled in the study will be closely monitored to determine if their cancer is responding to treatment and for any side effects that may occur.
New Drug Approvals 
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