Biofrontera AG, the specialist for suninduced skin cancer, has announced the full results of its Phase III clinical trial evaluating BF-200 ALA for the treatment of basal cell carcinoma (BCC) that demonstrate the study met its regulatory endpoints. The analysis fully confirmed the preliminary results, which were initially reported on January 28th 2016.
Results of the EU multi-center study confirm that 93.4% of patients treated with BF-200 ALA were cleared of all BCCs, compared to only 91.8% of patients treated with the comparator treatment, methyl aminolaevulinate (MAL) photodynamic therapy, which is marketed as Metvix® or Metvixia®.
In the study, 281 patients with 1 to 3 non-aggressive BCCs, including both superficial and nodular BCC subgroups, up to a thickness of 2 mm were treated. The analysis of the individual BCCs yielded a complete clearance rate of 94.6% after treatment with BF-200 ALA, compared to 92.9% with MAL (all values refer to the per protocol group). A stronger deviation of efficacy between the two drugs became apparent in thicker tumors. While 96.4% of tumors between 0 and 1 mm thickness were completely removed by treatment with BF-200 ALA (95.7% MAL), the value decreased in 1-2 mm tumors to 72.7% with BF-200 ALA and 66.7% with MAL. 89.3% of nodular BCCs, a subgroup of non-aggressive BCCs, were completely cleared with BF-200 ALA in comparison to only 78.6% with MAL.
In addition, treatment with BF-200 ALA resulted in an excellent cosmetic outcome. In 60.0 % of patients treated with BF-200 ALA, skin aesthetic appearance was strongly improved and rated by study physicians as very good to excellent, compared to only 48.6 % of patients treated with MAL. To evaluate these characteristics, various skin parameters had been qualified by the study physicians and graded by the severity of skin damage. The improvement of each parameter was documented and included in the analysis. An unsatisfactory result without cosmetic improvement was observed in 17.1% of BF-200 ALA patients and 18.9 % of patients treated with MAL.
"These are excellent results for the treatment of an infiltrating skin cancer, which we anticipate will aid in obtaining European labeling extension of BF-200 ALA for basal cell carcinoma potentially in Q4 of this year, which goes beyond the initial approval in actinic keratosis (AK) obtained in 2011. These results clearly demonstrate the high efficacy of PDT with BF-200 ALA's to destroy BCC tumor tissue across a range of tumor thicknesses without the formation of scar tissue and instead the promotion of skin regeneration for positive aesthetic outcomes. EMA approval of BF-200 ALA in BCC will significantly expand the market potential of BF-200 ALA in the EU", said Prof. Hermann Lübbert, CEO of Biofrontera AG.