Immuno-oncology firm Argos Therapeutics has completed the enrolment of patients in its Phase III ADAPT clinical trial of AGS-003.
The company has enrolled around 450 randomised patients in the trial of AGS-003 in combination with standard targeted therapy to treat metastatic renal cell carcinoma (mRCC).
AGS-003 is an autologous dendritic-cell based immunotherapy that is being developed to induce a memory T-cell response specific to each patient’s unique tumour antigens.
ADAPT trial co-principal investigator Dr Robert Figlin said: "Strong partnerships and coordination across our global study base to identify eligible patients and collect tumour samples have led to successful enrolment for the largest clinical trial ever conducted in patients with newly diagnosed, unfavourable risk, synchronous metastatic RCC."
AGS-003 has been produced through using a small sample from a patient’s own tumour and dendritic cells derived from a leukapheresis procedure.
In an open-label phase II study, treatment with AGS-003 plus sunitinib demonstrated a median overall survival of around 30 months in newly diagnosed and unfavourable risk mRCC patients, said Argos.
Argos Therapeutics clinical and medical affairs vice-president Doug Plessinger said: "We continue to believe that the combination of standard treatment with our personalised immunotherapy has the potential to bring new hope to mRCC patients, and we look forward to the next interim data review from the ADAPT trial in the first part of 2016."
The firm’s Arcelis is a fully personalised immunotherapy technology, which captures mutated and variant antigens that are specific to each patient’s disease.
The company has designed the technology to overcome immunosuppression by producing a durable memory T-cell response without adjuvants that may be associated with toxicity.