PhotoCure ASA announced today, positive results from its first phase III study on primary superficial basal cell carcinoma (BCC). In this study, more than 90% of the skin cancer lesions were completely cured three months after treatment with Metvix®, a topical photodynamic therapy (PDT). The two standard existing therapies for these lesions both have detrimental side-effects. Excision surgery can cause scarring and cryotherapy can lead to hypopigmentation.
The high cure rate after Metvix® PDT on these skin cancer lesions, confirms the positive results from previous phase II studies. The results from the initial response evaluation of this important phase III study, show that Metvix® PDT is equally effective as cryotherapy in removing this type of skin lesion. The study also shows that Metvix® PDT gives a better cosmetic outcome than cryotherapy. A total of 120 patients were enrolled in the study, involving 13 clinical centres in seven European countries.
Professor Nicole Basset-Séguin at St Louis Hospital in Paris, the study co-ordinator, was very satisfied with the results after three months which confirm the previous clinical experience at her institution. She commented further, “The high cure rate and excellent cosmetic outcome resulting from Metvix® PDT is very encouraging and if long term follow-up confirms these results, Metvix® PDT gives us a promising new treatment modality for this type of skin cancer.”
President and CEO, Vidar Hansson, is also very pleased with the results and comments, “We now have positive results from Metvix® PDT for treatment of primary BCC in addition to the previous published results in “high risk” BCC and pre-malignant actinic keratosis. Thus, we are on track in the documentation process for regulatory approval for all three indications. This will give more patients access to the benefits of this new treatment.”
BCC accounts for approximately 80% of non-melanoma skin cancers. There are over 1.7 million cases of BCC each year in Europe, the U.S. and Australia, and the incidence of the disease has grown at 5% per annum in the last decades. BCC is a locally invasive, slowly spreading tumour arising from the basal cell layer of the epidermis. The overall metastasis rate is very low, but if the tumour is not initially adequately treated, it may become more difficult to cure. Furthermore, the location of BCC has significant influence on its behaviour. The lesions that occur in the centre of the face tend to be more invasive and destructive, with greater risk of recurrence, and are more difficult to treat effectively. BCC on the nose is considered to be the location with highest risk and the most common location of recurrence. Patients with a primary BCC have a 47% chance of developing a second primary lesion within 3.5 years indicating the need for good follow-up in these patients.