Date: 2017-02-24
Type of
information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at the American Society of Clinical Oncology and Society for Imumunotherapy of Cancer (ASCO-SITC) Clinical Immuno-Oncology Symposium
Company: Oxford Biomedica (UK)
Product: TroVax® (MVA-5T4 Immunotherapy)
Action
mechanism:
- immunotherapy product/therapeutic vaccine. TroVax® is a therapeutic vaccine that stimulates the immune system to destroy cancerous cells expressing the 5T4 tumour antigen which is present on most solid tumours. The product comprises a modified vaccinia virus Ankara (MVA) vector, encoding the 5T4 antigen. Vaccinia viruses are commonly used as delivery systems for the development of antigen-specific vaccines.
- Results from 10 previous clinical trials in colorectal, renal and prostate cancer have shown that TroVax® is safe and well tolerated in over 500 patients; can be administered in combination with various other treatments and show clear indication of efficacy.
- Approximately 90% of patients treated with TroVax® mounted an anti-cancer immune response to the 5T4 antigen. TroVax® is currently in Phase II development for hormone refractory prostate cancer.
Disease: colorectal cancer
Therapeutic
area: Cancer - Oncology (UK)
Country: UK
Trial
details: The randomised, open-label Phase II study, entitled “TaCTiCC” (TroVax® and Cyclophosphamide Treatment in Colorectal Cancer), builds on four previous Phase I/II trials conducted by Oxford BioMedica where TroVax® was given to patients with CRC, in addition to research into CRC undertaken by Dr Andrew Godkin and Dr Awen Gallimore at Cardiff University, Wales. Led by Dr Andrew Godkin, the study will enrol up to 54 patients with inoperable metastatic CRC. The study will evaluate whether TroVax®, administered alone or in combination with cyclophosphamide, is effective in the treatment of CRC. The study will assess anti-5T4 immune responses following treatment, in addition to secondary measures of clinical benefit including progression-free survival, objective response rate and overall survival.
Latest
news:
- • On February 24, 2017, Oxford BioMedica notes the results from a Phase I/II clinical trial of MVA-5T4 immunotherapy (TroVax®) and low dose cyclophosphamide in patients with advanced colorectal cancer (TaCTiCC). A poster was presented by the clinical investigators in a poster session at the American Society of Clinical Oncology and Society for Imumunotherapy of Cancer (ASCO-SITC) Clinical Immuno-Oncology Symposium on 23 February 2017 in Orlando, USA.
- The poster described the open-label Phase I/II clinical trial involving 53 patients with inoperable, metastatic colorectal cancer who were randomised to receive either no treatment, low dose cyclophosphamide, TroVax® only or low dose cyclophosphamide followed by TroVax®. The primary study endpoint was to assess increased anti-5T4 responses after treatment on day 43 and the secondary endpoints were progression free /overall survival and anti-5T4 responses over the trial period.
- The study findings demonstrated that significant anti-5T4 immune responses were generated at treatment day 43. Secondary analysis revealed that both cyclophosphamide and TroVax® independently induced highly beneficial anti-tumour immune responses, resulting in significant survival of end stage colorectal cancer patients, without any major toxicity. This was the first randomised study to show a benefit of immunotherapy in advanced colorectal cancer patients.
Is
general: Yes
