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news.Cell Therapeutics' (CTI) preliminary results of a Phase II study of Paclitaxel poliglumex (OPAXIO) combined with Temozolomide (TMZ) and radiotherapy (RT) in patients with newly diagnosed high-grade gliomas, demonstrated high rate of complete and partial responses (CR and PR) and, a high rate of 6 month progression-free survival (PFS).
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CTI said that in the current study, patients received PPX with TMZ and RT for six weeks and the main toxicity was grade 4 thrombocytopenia and neutropenia in 6/25 patients, 5 patients of which were receiving concomitant medications which are known to be associated with thrombocytopenia; only 1 of 14 patients not receiving these concomitant medication developed grade 4 thrombocytopenia with PPX in combination with TMZ.
The study was presented by Suriya Jeyapalan, Heinrich Elinzano and Mark Goldman, assistant professors of Neurology and Neurosurgery, Brown University Oncology Group at the 2010 Scientific Meeting of the Society of Neuro-Oncology in Montreal, Canada.
The overall response rate was 45% (10 of 22) with 27% (6 of 22) of patients achieving a complete response and with a median follow up of 10.2 months, 76% of patients remained free from disease progression or death (so called progression free survival or PFS) at 6 months.
Suriya Jeyapalan said that standard therapy for patients with malignant brain tumors, like glioblastoma multiforme (GBM) employs a chemotherapy drug TMZ and RT and results in a PFS of 54% at 6 months.
"We were impressed by the high rate of complete and overall responses and importantly the durability of responses with the 6 month progression free survival being substantially longer than that reported with TMZ and RT alone," Jeyapalan said.
"Given that 55% of GBM tumors express MGMT, a gene responsible for inactivating the effectiveness of allkylating chemotherapy agents like TMZ, we are exploring whether or not PPX results in this trial were associated with anti-tumor activity in this otherwise TMZ resistant population which could lead to an accelerated clinical development path for PPX in MGMT+ GBM."
CTI chief medical officer Jack Singer said that the results were provocative when considering that standard of care with TMZ and RT results in a 6 month PFS of 54%.
"Given the high rate of response and durable PFS observed in this trial and the role of MGMT in conferring resistance to TMZ in more than half of GBM patients treated with the standard of care regimen (TMZ+RT) it is important to investigate whether PPX is able to bypass MGMT resistance as this could identify a genomically targeted population of patients with GBM for which PPX could provide meaningful durable responses and a potential additional accelerated route to approval," Singer said.