dm+d

Unassigned

New Medicines

ProphageGlioblastoma multiforme (GBM), newly diagnosed - first-line in combination with pembrolizumab

Information

Prophage
New molecular entity
Agenus
Agenus

Development and Regulatory status

None
None
Phase II Clinical Trials
Yes
Yes
Nov 20Agenus thinks that the probability of future clinical development efforts leading to marketing approval and commercialization of Prophage vaccines is highly uncertain. Prophage vaccines have been in clinical development for over 17 years, including multiple Phase 1 and 2 trials in eight different tumour types as well as randomised Phase 3 trials in metastatic melanoma and adjuvant renal cell carcinoma. To date, the only marketing approval for Prophage is in Russia where commercialisation of the approved product was unsuccessful. All currently planned trials involving Prophage are intended to be sponsored by third parties, and there is no guarantee that they will occur at all [9].
Nov 19Agenus has research and development operations in the UK and expects to pursue pathways to develop and commercialise its product candidates in both US and ex-US jurisdictions [8].
Jan 17Agenus and National Cancer Institute plan a phase II trial of vitespen and pembrolizumab for Glioma (Combination therapy, Newly diagnosed) in USA [4]
Sep 13Agenus is planning an end of PII meeting with the US FDA to discuss a pivotal PIII trial [2].
Sep 13Has orphan status in the EU & US for glioma [2].

Category

An autologous cancer vaccine that consists of purified tumour-derived heat shock proteins (HSPs), specifically HSP-96, that are complexed to tumour antigen peptides.
In England and Wales, about 1,860 gliomas are diagnosed each year, of which 740 to 840 are GBM (grade 4 glioma). Median survival is 11 mths. Glioblastoma Additional Details: multiforme (GBM), newly diagnosed - first-line in combination with pembrolizumab
Glioblastoma multiforme (GBM), newly diagnosed - first-line in combination with pembrolizumab
Intradermal

Trial or other data

Nov 21PII study (NCT03018288) has finished recruiting, after enrolling 90 participants. Collection of primary outcome data now expected to finish Jan 23 [11].
Dec 20Recruitment continues in PII study (NCT03018288), with an increased target of 108. Collection of primary outcome data not expected to complete until Mar 22 [10].
Dec 19PII study (NCT03018288) is recruiting [7].
Jun 19PII study (NCT03018288) is still recruiting; collection of primary outcome data now due to complete Jan 21 [6].
Dec 17PII study (NCT03018288) is still recruiting [5].
Jan 17PII study toevaluate the effect of vitespen, in combination with pembrolizumab on 1-year overall survival rate of patients with newly diagnosed glioblastoma (ndGBM) starts (NCT03018288). The efficacy-assessment trial will include two arms, where one arm will receive pembrolizumab as a monotherapy, and the other arm will receive both drugs in combination. The trial will be conducted by the Brain Tumor Trials Collaborative (BTTC) and will include 90 patients, 45 in each arm. Agenus will be responsible for supplying vitespen, while Merck will provide pembrolizumab for the trial. Collection of primary outcome data due to complete May 18 [5].
Jul 14Agenus announce final results from a PII study showing that patients with newly diagnosed glioblastoma multiforme (GBM) who received Agenus´ Prophage autologous cancer vaccine added to the standard of care treatment, lived nearly twice as long as expected. 50% of patients lived for two years, an encouraging result for a cancer that often kills patients within one year. Prophage patients demonstrated a median overall survival of approximately 24 months and 33% of patients remain alive at 2 years and continue to be followed for survival. Vaccine treated patients had a median PFS of nearly 18 months, approximately two to three-times longer than patients treated with radiation and temozolomide alone. 22% of patients were alive and without progression at 24 months [1].