Highlight Therapeutics announced positive Phase 2b results for its investigational intralesional basal cell carcinoma treatment, BO-112, at the European Academy of Dermatology and Venereology Congress in Vienna. The study met its primary endpoint of visual and pathological response at week 24 in patients with resectable primary low- and high-risk forms of the disease.
Phase 2b Trial Results at EADV Congress
The SPOTLIGHT-204 clinical trial evaluated 46 modified intention-to-treat patients with 54 evaluable lesions. According to trial data presented in Vienna, 61 percent of patients, or 28 out of 46, achieved the composite primary endpoint of visual and pathological response with a grade of 3 or better.
Stratified response rates showed that 70 percent of low-risk patients, or 7 out of 10, achieved the endpoint. Meanwhile, 58 percent of high-risk patients, or 21 out of 36, reached the same threshold.
The results were presented by Prof. Teresa Fernández-Figueras MD, PhD, during a late-breaking news session on Wednesday, 30 September, from 15:00 to 15:15. The presentation, identified as Abstract ID: LB-309, titled “SPOTLIGHT-204: Primary Results of Intralesional BO-112 in Resectable Basal Cell Carcinoma,” detailed the multicenter, single-arm Phase 2b trial (NCT06422936).
Facial lesion patients reach high complete response rates
Among high-risk head and neck patients, 56 percent achieved a complete visual and pathological response. For patients with facial lesions specifically, 62 percent reached complete response.
Josep Malvehy, Director of Skin Cancer Program, Dermatology Department, Hospital Clínic of Barcelona, noted that effective non-surgical options remain an unmet clinical need for this specific group. Mercedes Diz, chief executive officer of Highlight Therapeutics, stated in the company release that these findings give the firm strong conviction to advance BO-112 into late-stage development.
Trial reports mild adverse events without serious complications
The trial reported no serious adverse events and no treatment-related adverse events of grade 3 or higher.
The vast majority of treatment-related adverse events were mild. Ninety-one percent of reported events were graded as grade 1, and 88 percent resolved within three days.
Comparison with Existing Therapies
Basal cell carcinoma remains the most common human malignancy globally. While Mohs micrographic surgery and conventional surgery achieve high cure rates, they often cause significant scarring and functional compromise in sensitive areas like the face, head, and neck.
Existing approved treatments for advanced forms of the disease include Sanofi and Regeneron’s PD-1 targeted antibody Libtayo, approved by the FDA in 2021, alongside Novartis’ Odomzo and Genentech’s oral drug Erivedge. BO-112 differs by being a double-stranded RNA nanoparticle administered intralesionally to activate innate antiviral sensing pathways and induce tumor cell death.
Company Background
Highlight Therapeutics was established in 2010 as Bioncotech Therapeutics. In 2019, the firm collaborated with MSD, a Merck subsidiary, for a phase 2 trial combining BO-112 with Keytruda for patients with liver metastases from advanced solid tumors.
Frequently Asked Questions About SPOTLIGHT-204
What is the primary endpoint of the SPOTLIGHT-204 trial?
The primary endpoint is a composite of visual and pathological response at week 24, assessed by a central review committee.
What adverse events were reported during treatment?
No serious adverse events or grade 3 or higher treatment-related adverse events were reported, with 91 percent of adverse events classified as mild grade 1.
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