Head and neck cancer clinical trial reports high complete pathological response rate

BioVex announces that the data from its completed phase one/two clinical study of OncoVexGM-CSF for the first line treatment of head and neck cancer is being published in Clinical Cancer Research.

The previously announced top line results report a high complete pathological response rate and a low relapse rate in combination with cisplatin and radiation, combined with a relatively benign side effect profile.

Following from this data, a phase three study, also in patients with previously untreated squamous cell carcinoma of the head and neck, will begin later this year under an SPA (Special Protocol Assessment) from the FDA.

In the study published, OncoVexGM-CSF was injected into 17 patients’ cancer-affected lymph nodes in up to four doses, and the patients were also given radiotherapy and chemotherapy. Head and neck tumour shrinkage could be seen on scans for 14 patients (82.3 percent), while 93 per cent of patients had no trace of residual cancer in their lymph nodes when subsequently surgically removed.

After an average follow-up time of 29 months (19 to 40 months), 82.4 percent of patients remained alive. Only two of 13 patients given the top virus treatment dose relapsed, and no patient had recurrent loco-regional disease.

Side-effects were generally mild to moderate, and most, except fever and fatigue, were thought to be due to the chemotherapy or radiotherapy.

OncoVexGM-CSF has previously shown promising results when administered on its own in patients with other cancer types, including a phase two trial in metastatic melanoma patients where a phase three trial is currently underway.

Around 650,000 people are diagnosed with squamous cell cancer of the head and neck each year worldwide, and around 350,000 die from the disease annually.

Dr Robert Coffin, founder and CTO, BioVex, said: “Up to half of patients given the current standard treatment of chemotherapy combined with radiotherapy typically relapse within two years, following which the prognosis is grim, so these results compare very favorably. This, combined with the very high complete pathological response rate indicates that OncoVexGM-CSF may provide significant additional clinical benefit to chemotherapy and radiotherapy alone, hence our decision to move directly to a pivotal phase three trial.

In addition to head and neck cancer, and melanoma where a pivotal phase three trial is currently underway, we also believe that OncoVexGM-CSF has significant potential to treat a wide variety of other tumor types either alone or in combination with other therapies, for which the planning of additional clinical trials is underway.”