Current Edition

Early findings from a phase 3 clinical trial report promising results

The interim results from a phase 3 clinical trial testing DCVax®-L, a dendritic cell treatment, show increased overall survival for patients with glioblastoma.

Dendritic cells are a type of immune cell that function to help the body’s immune system recognise and attack tumour cells. DCVax®-L is a personalised immune therapy that is made from each patient’s own dendritic cells.
The process of making this treatment is complex and involves taking both tumour cells and blood from the patient. Immune cells are separated from the patient’s blood and exposed to the tumour cells – it is through this process that dendritic cells learn to recognise the specific markers and proteins associated with the patient’s tumour cells. The “educated” dendritic cells are then injected back into the patient where they go on to recruit and “teach” other immune cells to recognise and attack the cancerous cells.
DCVax®-L, developed by Northwest Biotherapeutics, is currently being tested in a phase 3 clinical trial consisting of 331 individuals with glioblastoma, an aggressive and lethal form of brain cancer.
All the participants in the trial underwent the current standard of treatment, which included surgery, followed by 6 weeks of radiotherapy and chemotherapy with temozolomide. Following this initial treatment phase, patients were randomised 2:1 to receive either DCVax®-L plus temozolomide (232 patients), or a placebo (a harmless substitute for DCVax®-L) plus temozolomide (99 patients).
However, the study was designed in such a manner that all patients who experienced tumour recurrence were offered DCVAx®-L, and at the time of the interim analysis, majority of the trial participants (86.4%) had received the treatment.
The results of this international, multicentre trial show an increased median overall survival rate of 23.1 months for patients receiving DCVax®-L in addition to the current standard of treatment. In comparison, the median overall survival rate is 15-17 months for patients receiving only the current standard of treatment.
Unlike chemotherapy and radiotherapy, DCVax®-L, which is administered by an intra-dermal injection in the arm (similar to a flu jab), caused no reported major side effects in the vast majority of patients. The researchers say that only seven of the 331 patients who took part reported any significant side effects that may have been related to their treatment.
If DCVax®-L is shown to be effective upon the successful completion of this phase 3 clinical trial, it could lead to a paradigm shift in the treatment of brain tumours. The therapy may be administered in a wide range of clinical settings, as well as be used in combination with a wide range of other treatments.