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Jump to Key Points VIENNA — More than half of patients with high-risk basal cell carcinoma (BCC) of the head and neck (18 of 32; 56%) had no visible tumor and no viable tumor on pathology 24 weeks after three intralesional injections of the experimental RNA immunotherapy BO-112, a phase 2b trial found.
The complete response rate was slightly higher among the subgroup of patients with high-risk facial lesions, at 62% (16 of 26).
Across the 46-patient efficacy population, 28 patients (61%) met the trial’s broader primary endpoint: None of their treated lesions had visibly grown, and no more than 50% viable tumor remained on pathology.
Data from the SPOTLIGHT-204 study were presented here during the first late-breaking news session of the European Academy of Dermatology and Venereology (EADV) 2026 Congress.
- BO-112: intralesional RNA immunotherapy for resectable high-risk BCC.
- 56% complete response at 24 weeks; facial lesions 62%.
- 61% met broader endpoint: no growth + ≤50% viable tumor.
- Three injections days 1, 8, 15; all lesions excised at week 24.
- No serious AEs; most reactions mild, transient injection-site/flu-like.
Novel Nonsurgical Approach
Dermatopathologist Maria Teresa Fernandez-Figueras, MD, who runs a lab at Centro Médico ADAME in Barcelona, Spain, reported that BO-112 is a noncoding synthetic double-stranded RNA nanoparticle designed for direct injection into BCC lesions as a nonsurgical option.
“Basal cell carcinoma has the ability to hide the tumor from immune surveillance,” she explained to Medscape News Europe. The treatment unmasks tumor cells, producing an antiviral response that causes direct, immune-meditated cell death, followed by innate and adaptative immune response activation. “So it’s lots of cytotoxic CD8+ T-cells destroying the tumor,” she said.
Fernandez-Figueras added that it quickly becomes obvious if a patient will respond to treatment, which is usually a complete response in that case. She added that even when a patient does not completely respond, the residual tumor is often smaller and more superficial, potentially making surgical excision easier.
The SPOTLIGHT-204 Trial
SPOTLIGHT‑204 is an open-label, nonrandomized, multicenter, single‑arm clinical trial evaluating the efficacy, safety and tolerability of intralesional BO‑112 in patients with primary resectable BCC.
Fifty patients were enrolled in the trial overall; 40 with high-risk BCC, most of whom presented with tumors affecting the head and neck. The median age of participants was 75 years (range, 34-90) and 48% of patients were women.
At study entry, all participants had a punch biopsy of their lesions before receiving three separate injections of BO-112 on days 1, 8, and 15.
Standardized clinical photography was used to assess the short-term effects of the intralesional treatment at weeks 7, 12, and 18. Complete surgical excision of the studied lesions was done at week 24, with histopathologic assessment. Excision was performed even if there were no visible lesions present, albeit a smaller area of tissue removed for examination.
Importantly, no serious adverse events were reported during the trial, while almost all (91%) reactions that did occur were grade 1 and most (88%) resolved within 3 days. The most common adverse reactions were related to the injection site or mimicked a light cold, said Fernandez-Figueras. These included symptoms such as fever in 10 patients; headache in six patients; an influenza-like illness in four patients; and body weakness, malaise, or muscle aches in 10 patients.
Surgery Remains Standard
Marcus Muche, MD, PhD, a specialist in dermato-oncology and Mohs micrographic surgery, who practices at Mohs Klinieken Hoorn in Netherlands, told Medscape News Europe that the approach currently lacks the certainty and efficacy of conventional Mohs surgery and he is not convinced to use it if it were available.
“That’s not because I am a surgeon,” he said. Instead, it’s because surgical excision is usually a “simple 50-minute” procedure, followed by “the certainty that everything is gone.”
“So, if you come with something which I had to inject, and then it’s a 61% [response] after a couple of months, then I would tell the patient [that surgery takes] 50 minutes and it’s 95%-96% [effective],” he said.
Patients with BCC are closely followed up after surgery, he added, not because of concerns that the treated tumor will recur but because people with BCC often develop further distinct tumors that are not due to metastasis.
Currently, there really is no option other than Mohs surgery for BCC, Muche stated. Even radiotherapy has not hit the mark of matching surgical outcomes in the trials that have been conducted. Still, Muche said he has no doubt that one day a noninterventional option, such as a cream, might become available.
“At the moment, I favor surgical therapy. But of course, it depends on the single case,” he said. In someone who was heavily treated, had a lot of scars, or someone with a special genetic syndrome who developed hundreds or thousands of BCCs, or whose BCC developed another color, “then of course you may think about it.”
SPOTLIGHT-204 was funded by Spanish biotech company Highlight Therapeutics. Fernandez-Figueras was a member of the trial’s Central Review Committee and has received honoraria from Highlight Therapeutics.
Muche reported no relevant financial relationships.
Sara Freeman, MSc, is a freelance medical journalist based in London, UK. She has been reporting for specialist healthcare news organizations for more than 20 years.
