(CHICAGO, IL) – Nimotuzumab does not improve survival among newly diagnosed glioblastoma patients when added to standard temozolomide chemoradiotherapy, but warrants further study among patients with MGMT nonmethylated glioblastoma, according to a randomized multicenter phase 3 study reported at the 2012 American Society of Clinical Oncology Annual Meeting.
The lead author for this open-label, multicenter, randomized phase 3 trial was Manfred Westphal, MD, Department of Neurosurgery, UKE Hamburg, Hamburg, Germany. The trial was conducted to determine the efficacy of nimotuzumab in the treatment of gliomas, since it is known that nimotuzumab binds preferentially to cells that are highly overexpressing epidermal growth factor receptor (EGF-R), a cell division signaling protein consistently expressed or over-expressed in malignant glioma cells.
Newly diagnosed patients with histology-confirmed glioblastoma were randomized to nimotuzumab treatment (n=71) following 12 weeks of standard temozolomide chemotherapy and radiotherapy, or chemotherapy alone (n=71).
Survival rates were not statistically significant between treatment and control arm patients. Overall survival (OS) was 22.3 months (CI:17.2–26.6) vs 19.6 (CI:14.8–24.0) months.
Tumor EGF-R, hypoxia, and DNA repair enzyme O-6-methylguanine-DNA methyltransferase (MGMT) were also assessed. For nonmethylated MGMT-tumor patients in the treatment arm (n=28), median OS was 19.6 months (CI:15.8–28.0) vs 15.0 months (CI:13.0–20.3) among 28 patients in the control arm.
Tumor hypoxia was not predictive of outcomes the overall group but could prove relevant in subgroups, Dr. Westphal reported. He added that adverse events, “did not reveal a new specific toxicity profile beyond the known side effects from glioma treatment with current standard.”
In conclusion, Dr. Westphal and colleagues said that “nimotuzumab shows a clear trend towards efficacy in MGMT nonmethylated glioblastoma patients. And the safety profile and indications for subgroup efficacy potentially justify focused evaluation of antibody therapy against glioblastoma.”