July 02, 2014
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Glioblastoma vaccine improved OS vs. standard care

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The addition of heat shock protein-peptide complex-96 vaccine significantly extended OS compared with standard care alone among patients with newly diagnosed glioblastoma multiforme, according to phase 2 final data analysis.

In a single-arm, multi-institutional, open-label, phase 2 study, 46 patients with newly diagnosed glioblastoma multiforme were treated with surgical resection, radiation and temozolomide as the standard of care in addition to heat shock protein-peptide complex-96 (HSPPC-96; Prophage G-100, Agenus Inc.) vaccination.

Patients who received HSPPC demonstrated a median OS of 23.8 months vs. 14.6 months among patients who received standard treatment alone. Additionally, 33% of patients remained alive at 2 years and continued to be followed for survival compared with standard of care, in which 26% of patients were alive at 2 years.

 

Andrew Parsa

“These data suggest that Prophage is generating an effective immune response which is translating into an extension in survival far beyond what is historically seen in patients with [glioblastoma multiforme]. These data provide the impetus for a definitive, randomized clinical trial,” Andrew Parsa, MD, PhD, chair of the department of neurological surgery at the Feinberg School of Medicine at Northwestern University, said in a press release. “Glioblastoma tumors are often resistant to standard therapies and the extended progression-free survival and proportion of long-term survivors is very encouraging.”

Besides the long-term survival data, patients treated with HSPPC exhibited a median PFS of 17.8 months, approximately two to three times longer than patients treated with standard of care treatment alone.

Researchers noted that the response to HSPPC seems to be more distinct among those patients with less expression of the checkpoint ligand PD-L1 on the white blood cells, indicating that combinations of HSPPC with checkpoint modulators, such as PD-1 antagonists, could increase HSPPC effectiveness in a greater percentage of patients with glioblastoma multiforme.

“We believe that Prophage may play an important role in changing the treatment paradigm for patients with glioblastoma multiforme,” Garo Armen, PhD, CEO and chairman of Agenus Inc., said in a press release. “We are exploring partnerships for phase 3 studies of Prophage in glioblastoma multiforme. Additionally, we are excited about the potential combinations of Prophage with PD-1 antagonists and other checkpoint modulators in glioblastoma multiforme.”