Agenus Prophage (Heat-Shock Protein Peptide Complex-96) Vaccine

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Drug Name Agenus Prophage (Heat-Shock Protein Peptide Complex-96) Vaccine
FDA Approval In clinical trials; not yet FDA-approved
Used for Recurrent heavily pretreated glioblastoma multiforme (GBM) and newly diagnosed GBM
Clinical Trial Phase Phase II
Clinical Trial Explanation Not specified
Common Side Effects Not explicitly detailed; similar immunotherapy treatments often include flu-like symptoms, injection site reactions, fatigue
OS without Historical controls suggest a median survival time of 6 months for recurrent GBM
OS with Median survival of 42.6 weeks (~9.8 months) in recurrent GBM; Median survival of 23.8 months in newly diagnosed GBM when combined with the Stupp protocol
PFS without Typically less than 7 months for newly diagnosed GBM under standard treatment
PFS with 17.8 months for newly diagnosed GBM, possibly the longest PFS seen in a phase II trial for GBM
Usefulness Rating 4
Usefulness Explanation The vaccine shows promise, especially in extending progression-free survival in newly diagnosed GBM. It offers a novel approach by leveraging the patient's immune system, potentially improving outcomes in a disease with few effective treatments.
Toxicity Level 2
Toxicity Explanation While specific side effects are not detailed, similar vaccines have been associated with manageable side effects like flu-like symptoms, suggesting a relatively low toxicity level.


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From Ben Williams Book: A variation in the use of dendritic cells first subjected tumor tissue to a heat-shock treatment to elevate the expression of heat-shock proteins, which were extracted from the blood and incubated with dendritic cells from individual patients. In a clinical trial (163) conducted at UCSF and Columbia for patients with recurrent heavily pretreated tumors, the vaccine produced a median survival of 42.6 weeks (about 9.8 months), which compares favorably to the 6-month survival time for historical controls, and is comparable to the 9-11 months when Avastin is used with patients with recurrent tumors.

A subsequent news release from Agenus, Inc, a biotech company sponsoring the research, reported the results of phase II clinical trial in which the heat-shock dendritic vaccine was combined with the standard Stupp protocol (164). Median progression-free survival was 17.8 months and median survival was 23.8 months. This median progression-free survival of 17.8 months is perhaps the longest PFS yet seen in any substantially sized phase 2 trial for newly diagnosed glioblastoma.

Follow-up data (reference 339, abstract 2011) presented at the ASCO 2015 conference revealed that patients with high PD-L1 expression (the ligand for the PD-1 immune checkpoint on the surface of immune cells which is the target for the therapeutic antibodies nivolumab and pembrolizumab) had a median survival of 18 months, while those with low expression of PD-L1 had a median survival of 44.7 months. This finding suggests that efficacy of the heat shock protein peptide vaccine could be greatly improved by co-administration of PD-1 antibodies such as nivolumab or pembrolizumab.Property "Has original text" (as page type) with input value "A variation in the use of dendritic cells first subjected tumor tissue to a heat-shock</br>treatment to elevate the expression of heat-shock proteins, which were extracted from the</br>blood and incubated with dendritic cells from individual patients. In a clinical trial (163)</br>conducted at UCSF and Columbia for patients with recurrent heavily pretreated tumors,</br>the vaccine produced a median survival of 42.6 weeks (about 9.8 months), which</br>compares favorably to the 6-month survival time for historical controls, and is</br>comparable to the 9-11 months when Avastin is used with patients with recurrent tumors.</br></br>A subsequent news release from Agenus, Inc, a biotech company sponsoring the research,</br>reported the results of phase II clinical trial in which the heat-shock dendritic vaccine was</br>combined with the standard Stupp protocol (164). Median progression-free survival was</br>17.8 months and median survival was 23.8 months. This median progression-free</br>survival of 17.8 months is perhaps the longest PFS yet seen in any</br>substantially sized phase 2 trial for newly diagnosed glioblastoma.</br></br>Follow-up data (reference 339, abstract 2011) presented at the ASCO 2015 conference</br>revealed that patients with high PD-L1 expression (the ligand for the PD-1 immune</br>checkpoint on the surface of immune cells which is the target for the therapeutic</br>antibodies nivolumab and pembrolizumab) had a median survival of 18 months, while</br>those with low expression of PD-L1 had a median survival of 44.7 months. This finding</br>suggests that efficacy of the heat shock protein peptide vaccine could be greatly improved</br>by co-administration of PD-1 antibodies such as nivolumab or pembrolizumab." contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process.

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