Novel Photodynamic Therapy Yields Clearance in Basal Cell Carcinoma

Investigators of the double-blind, placebo-controlled, multicenter ALA-BCC-CT013 study (NCT03573401) are assessing 187 patients with at least 1 clinically and histologically confirmed sBCC.

Treatment with the investigational photodynamic therapy (PDT) Ameluz in combination with the BF-RhodoLED lamp produced statistically significant outcomes among patients with superficial basal cell carcinoma (sBCC), according to findings from the phase 3 ALA-BCC-CT013 study (NCT03573401).¹

PDT with Ameluz achieved complete clinical and histological clearance of a preselected “main target” BCC lesion among 65.5% (n = 95/145) of patients compared with a success rate of 4.8% (n = 2/42) among those who received placebo-PDT (P <.0001). Additionally, complete histological clearance was reported in 75.9% (n = 110/145) and 19.0% (n = 8/42) of patients, respectively. Data also showed a complete clinical clearance rate of 83.4% (n = 121/145) and 21.4% (n = 8/42) in each respective arm.

Investigators highlighted that all other secondary efficacy end points reached statistical significance in the trial (P <.0001). Total clearance of all sBCC lesions occurred in 64.1% of patients who received Ameluz-PDT compared with 4.8% of those who received placebo-PDT. Additionally, 64.3% and 22.2% of patients in the Ameluz arm evaluated their overall treatment satisfaction and aesthetic outcome as “very good” or “good,” respectively.

“I have used Ameluz-PDT in my practice for many years for the treatment of Actinic Keratosis, and we were pleased to be a part of such an extensive and rigorous study to examine its use in patients with [sBCC],” coordinating study investigator David M. Pariser, MD, of Virginia Clinical Research and Pariser Dermatology, stated in a press release.¹

According to Hermann Luebbert, PhD, chief executive officer and chairman of Biofrontera—the developers of Ameluz-based PDT—the completion of the 1-year follow-up portion of the study is anticipated to take place in December 2024. Following the conclusion of this phase, developers look to submit a dossier to the FDA between the second and third quarter of 2025 in support of Ameluz-PDT for patients with sBCC.

Investigators of the double-blind, placebo-controlled, multicenter ALA-BCC-CT013 study are assessing 187 patients with at least 1 clinically and histologically confirmed sBCC. Patients were randomly assigned to receive a topical application of Ameluz containing 7.8% 5-aminolevulinic acid (5-ALA) or a topical application vehicle containing no active ingredient.²

The trial’s primary end point is the complete clinical and histological response of a patient’s main target lesion at 12 weeks following the initiation of the last PDT cycle directed towards the main target lesion. Secondary end points include the main target lesion clinical response rate, the main target lesion histological response rate, the patient complete clinical response rate, and patient satisfaction with aesthetic outcomes and treatment.

Patients 18 years and older with the presence of 1 or more sBCC lesions in the face or forehead, bald scalp, and extremities and/or neck or trunk were eligible for enrollment on the trial. Other requirements for study entry included having willingness to undergo up to 4 cycles of PDT within 3.5 months, no significant physical abnormalities within the potential treatment field, acceptance to abstain from extensive sunbathing, and willingness to stop using moisturizers or any other cosmetics within the treatment field.

Those with a history of hypersensitivity to 5-ALA, current treatment with immunosuppressive therapy, or evidence of clinically significant unstable medical conditions such as metastatic tumors were ineligible for enrollment on the trial.

“I am excited that the potential FDA approval may provide me with a new noninvasive option for my patients that may not involve potential scarring, or repeated office visits for ionizing radiation, and which could therefore lead to reduced patient burden and a beneficial cosmetic outcome,” main study contributor Todd Schlesinger, MD, FAAD, FASMS, a board-certified dermatologist and Mohs surgeon, concluded.¹

References

1. Biofrontera Inc. announces highly significant results in phase 3 study of Ameluz-photodynamic therapy (PDT) regarding the treatment of superficial basal cell carcinoma (sBCC). News release. Biofrontera, Inc. October 31, 2024. Accessed November 4, 2024. https://tinyurl.com/5kyk2u4n
2. Study to evaluate the safety and efficacy of BF-200 ALA (Ameluz) and BF-RhodoLED in the treatment of superficial basal cell carcinoma (sBCC) with photodynamic therapy (PDT). ClinicalTrials.gov. Updated June 26, 2024. Accessed November 4, 2024. https://tinyurl.com/2s49kbdm