EMA Asked to Conditionally Approve Gliovac, Cancer Vaccine, for Recurrent Glioblastoma

EMA Asked to Conditionally Approve Gliovac, Cancer Vaccine, for Recurrent Glioblastoma

ERC Belgium has asked the European Medicines Agency (EMA) to give conditional approval to its investigational anti-cancer vaccine Gliovac (ERC1671) for the treatment of recurrent glioblastoma, an aggressive form of brain cancer.

Gliovac, which the company also refers to as Sitoiganap, is an advanced form of immunotherapy made up of cancer cells and other tumoral components freshly collected from the patient (autologous tissue) and three or more other people with the same type of brain tumor (allogeneic tissue).

Upon injection, Gliovac is expected to work like a standard vaccine, boosting a patient’s immune system to mount an immune response against glioblastoma cells, eliminating them.

The company’s request was submitted as a marketing authorization application to the EMA. It is supported by interim data from a Phase 2 trial (NCT01903330) investigating the safety and effectiveness of Gliovac in recurrent glioblastoma patients in combination with Leukine (sargramostim) and cyclophosphamide, plus the cancer medicine bevacizumab.

The trial, designed to enroll up to 84 patients, is determining whether the combination therapy containing Gliovac and bevacizumab is safe and superior to a placebo plus bevacizumab at prolonging median overall survival in patients. Progression free survival — the time patients live without disease worsening — and immune responses are also being examined.

Interim study findings, in a total of nine patients whose data could be “unblinded,” showed that the Gliovac combination therapy lengthened overall survival, from a median of 7.6 months on bevacizumab alone to 12.1 months with the combo treatment. One person in the Gliovac group lived for more than two years, while all those given bevacizumab plus a placebo died within one year.

Gliovac’s use also prolonged the time these people lived without disease progression — 7.3 months vs. 5.4 months.

The percentage of patients responding to treatment was also higher among the Gliovac combo therapy (75%) group, compared with those given bevacizumab alone (25%).

Combination treatment patients also attained durable responses, with one who achieved a partial response (partial cancer elimination) after one treatment cycle maintaining it from more than seven months.

Higher numbers of immune T-cells — indicative of the therapy’s effectiveness — were also found to be associated with improvements in patients’ overall survival among those on the combination therapy. Similar correlations were not found among those on bevacizumab alone.

“We are excited to see such strong results from Sitoiganap, especially the high number of patients going into remission,” Apostolos Stathopoulos, MD, PhD, president and CEO of ERC, said in a press release.

“The beneficial advantage that we are bringing to patients suffering from this orphan disease like GBM [glioblastoma] is groundbreaking, especially being able to help those patients who have advanced to a stage without alternative therapeutic options,” Stathopoulos added.

The combination therapy was also found to be safe. No life-threatening or fatal adverse events were reported.

The distribution of adverse events was similar in both treatment groups, with the most common being injection site reactions. Headaches were the most frequent severe adverse event observed.

“Preliminary analysis of interim results from our study indicates that the addition of ERC1671 [plus sargramostim, and] cyclophosphamide to bevacizumab resulted in a clinically meaningful survival benefit with minimal additional toxicity,” the trial investigators wrote.

A conditional marketing authorization is given by the EMA to medicines for serious or life-threatening diseases where benefit is being shown to speed patient access. Specific obligations, including further data from ongoing or new studies, are typically required for full approval.