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A phase II, multicenter trial of rindopepimut (CDX-110) in newly diagnosed glioblastoma: the ACT III study
James Schuster1, Rose K Lai1, Lawrence D Recht1
1Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania (J.S.); The Neurological Institute of Columbia University, New York, New York (R.K.L.); Stanford Cancer Center, Stanford, California (L.D.R.); Duke University Medical Center, Durham, North Carolina (D.A.R., G.E.A., D.D.B., J.H.S.); Evanston Northwestern Healthcare, Evanston, Illinois (N.A.P.); University of Texas M.D. Anderson Cancer Center, Houston, Texas (M.D.G.); University of Washington School of Medicine, Seattle, Washington (M.M.M.); Huntsman Cancer Institute at the University of Utah, Salt Lake City, Utah (R.J.); Yale University School of Medicine, New Haven, Connecticut (J.M.B); University Hospital-Case Medical Center & Case Comprehensive Cancer Center, Cleveland, Ohio (A.S.); Scott Cruickshank & Associates, Inc., Santa Barbara, C alifornia (S.C.); Celldex Therapeutics, Inc., Hampton, New Jersey (J.A.G., T.K., T.A.D.); University of Texas M.D. Anderson Cancer Center, Houston, Texas (A.B.H.).
Background:
The epidermal growth factor receptor variant III deletion mutation, EGFRvIII, is expressed in ∼30% of primary glioblastoma and linked to poor long-term survival. Rindopepimut consists of the unique EGFRvIII peptide sequence conjugated to keyhole limpet hemocyanin. In previous phase II trials (ACTIVATE/ACT II), rindopepimut was well tolerated with robust EGFRvIII-specific immune responses and promising progression-free and overall survival. This multicenter, single-arm phase II clinical trial (ACT III) was performed to confirm these results.
Methods:
Rindopepimut and standard adjuvant temozolomide chemotherapy were administered to 65 patients with newly diagnosed EGFRvIII-expressing (EGFRvIII+) glioblastoma after gross total resection and chemoradiation.
Results:
Progression-free survival at 5.5 months (∼8.5 mo from diagnosis) was 66%. Relative to study entry, median overall survival was 21.8 months, and 36-month overall survival was 26%. Extended rindopepimut vaccination (up to 3.5+ years) was well tolerated. Grades 1-2 injection site reactions were frequent. Anti-EGFRvIII antibody titers increased ≥4-fold in 85% of patients, and increased with duration of treatment. EGFRvIII was eliminated in 4/6 (67%) tumor samples obtained after >3 months of therapy.
Conclusions:
This study confirms, in a multicenter setting, the preliminary results seen in previous phase II trials of rindopepimut. A pivotal, double-blind, randomized, phase III trial ("ACT IV") is under way.
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