Transgene SA is to collaborate with the European Organization for Research and Treatment of Cancer (EORTC) for the conduct of a randomized phase 2b study of TG4001 in patients with HPV16 positive Oropharyngeal Squamous Cell Carcinomas (OSCCs).
The study will be a multinational, placebo controlled, randomized, phase 2b trial led by the EORTC in which TG4001 will be administered in combination with chemo-radiotherapy in patients with HPV16 positive OSCCs whose tumor is locally advanced (non-metastatic). The main objective of the study will be to show a reduction in the relapse rate in patients receiving TG4001 in addition to this standard of care. Approximately 200 patients should be enrolled.
“The EORTC welcomes this new partnership with Transgene aiming at improving outcomes for the HPV16-positive subset of patients” said EORTC Director Dr. Denis Lacombe. He added: “Currently the standard treatment is chemo-radiotherapy and we believe combining it with TG4001, an HPV-targeted immunotherapy, could potentially improve the survival rate of patients.”
The trial is scheduled to start in late 2013 and should deliver its first safety and efficacy results in 2016. Under certain conditions, to be further discussed between Transgene and EORTC, this clinical trial could be extended to a phase 3 that could serve as a registrational study for TG4001 in this indication.
Since 2011, Transgene has regained full rights to TG4001 from Roche. Clinical results (released in 2012) from a phase 2b trial conducted by Roche in 206 high grade cervical dysplasia (CIN2/3) patients demonstrated a significant level of activity of the therapeutic vaccine compared to placebo.
"We are very pleased to announce this collaboration with the EORTC, a leading independent European cancer research organisation which is at the forefront of the development new cancer treatment strategies” said Philippe Archinard, President and CEO of Transgene. He added: “This is an opportunity to improve the cure rate for patients and also a good opportunity for Transgene to explore and extract value from this asset, for which interesting proof of concept data were previously obtained in a monotherapy trial. The combination of therapeutic vaccine and chemotherapy is based on a strong clinical rationale as evidenced by Transgene in a previous trial combining TG4010, an MVA-MUC1 vaccine, to chemotherapy in non-small cell lung cancer."
The market for head and neck cancers was valued by Transgene at $1 billion in annual sales in 2010. It is currently growing fast and is expected to reach close to $2 billion in value by 2017. This growth is primarily attributed to the increasing prevalence and diagnosis rate of the disease but also to the introduction of new effective therapies as unmet medical needs are significant. Transgene estimates the eligible population (incidence) for the combination of TG4001 and radio-chemotherapy in the HPV16-related head and neck squamous cell carcinomas (HNSCC) to be between 10,000 and 15,000 patients. As the only HPV-targeted therapy in advanced clinical development in HNSCC, the combination could expect a penetration superior to 50% of the eligible population