Intralesional BO-112 Shows Promise as Nonsurgical Approach for High-Risk BCC

Intralesional BO-112 demonstrated promising clinical and pathological responses in patients with resectable basal cell carcinoma (BCC), including patients with high-risk tumors of the head and neck, according to phase 2b results presented at the 2026 European Academy of Dermatology and Venereology (EADV) Congress in Vienna, Austria.¹

The findings from the multicenter, single-arm SPOTLIGHT-204 trial (NCT06422936) suggest that the investigational therapy could eventually offer a nonsurgical treatment option for selected patients with BCC, particularly when tumors occur in cosmetically or functionally sensitive areas.

In an interview with Dermatology Times, Josep Malvehy, MD, PhD, professor at the University of Barcelona and director of the Skin Cancer Program in the Dermatology Department at Hospital Clínic of Barcelona, highlighted the potential implications of reducing or avoiding surgery in this population.

“Many of these cancers are appearing on the face and very sensitive cosmetic areas,” Malvehy said. “It’s now the time that we are reconsidering that we can, in some cases, reduce the size of these tumors or even treat the tumors with complete responses with intralesional therapies.”

SPOTLIGHT-204 Results

SPOTLIGHT-204 evaluated the efficacy, safety, and tolerability of intralesional BO-112 in patients with resectable primary low- and high-risk BCC. The trial enrolled 50 patients, including 40 with high-risk disease and 10 with low-risk disease. Of the high-risk population, 36 patients had head and neck lesions.

Patients received 3 once-weekly intralesional injections of BO-112 followed by complete surgical excision at week 24. The median patient age was 75 years, and 48% of participants were women.

The modified intention-to-treat population included 46 patients with 54 evaluable lesions. At week 24, 61% (28/46) of patients achieved the study's primary composite end point of visual and pathological response across all treated lesions.

Responses were observed across risk groups, with 58% (21/36) of patients with high-risk BCC and 70% (7/10) of those with low-risk disease achieving visual and pathological responses.

Notably, complete visual and pathological responses were achieved in 56% (18/32) of patients with high-risk head and neck BCC and 62% (16/26) of patients with facial lesions.

For Malvehy, the responses observed among patients with more aggressive tumors were particularly noteworthy.

“This treatment was useful in high-risk pathological BCCs, so infiltrative, very aggressive [tumors],” he said. After reviewing the cases with the study team and dermatopathologist M. Teresa Fernández-Figueras, MD, PhD, Malvehy noted that many tumors were histologically aggressive. “They were responding in more than 50% of the cases. So we are really excited.”

Potential to Reduce Surgical Burden

Surgery remains central to the management of BCC and can achieve high cure rates. However, treatment can become more complicated when tumors arise on the nose, face, or other anatomically sensitive areas, where excision may carry cosmetic or functional consequences.^2,3

Malvehy explained that local therapies could potentially reduce tumor size before surgery or, if confirmed in further trials, allow some patients to avoid more extensive procedures.

“With some local therapies like this one, we can reduce significantly the amount of patients that are at the end requiring these surgeries, or even we can reduce, possibly, the damage or the surgeries,” he said.

Importantly, patients in SPOTLIGHT-204 still underwent excision at week 24, allowing investigators to assess whether apparent clinical responses corresponded with pathological clearance.

“We excised them all,” Malvehy said. “More than 50% are having complete responses at the pathological level and also the clinical dimension.”

He emphasized, however, that the findings should be interpreted in the context of the study's design.

“This is just a phase 2,” Malvehy said. “Phase 2 means we don’t have a comparative group versus surgery...so efficacy has always to be considered with caution.”

Despite that limitation, he described the results as promising given the number of patients with BCC who could potentially benefit from an effective local treatment.

Safety and Next Steps

BO-112 was also generally well tolerated. No serious adverse events, grade 3 or higher treatment-related adverse events, or treatment discontinuations were reported. Of treatment-related adverse events, 91% were grade 1, and 88% resolved within 3 days.

Malvehy similarly characterized tolerability as favorable, noting that investigators primarily observed inflammatory changes around treated tumors and relatively little pain.

“The patients had very low risk of having significant toxicities or significant problems during the treatment,” he said. “We saw some inflammatory changes in the tumor [and] not much pain compared to other intralesional therapies that we have today in clinical trials.”

BO-112 is a double-stranded RNA nanoparticle administered directly into the tumor. Its proposed immunotherapeutic activity involves activation of innate antiviral sensing pathways, induction of immunogenic tumor cell death, and development of tumor-specific adaptive immunity.

The phase 2b findings support further investigation of the therapy, with phase 3 development representing an important next step in determining whether the responses observed in SPOTLIGHT-204 translate into a viable alternative or complement to surgery.

“This is a very promising, very positive result because we have so many patients that could benefit,” Malvehy said.

References

1. Fernández-Figueras MT, et al. SPOTLIGHT-204: Primary results of intralesional BO-112 in resectable basal cell carcinoma. Presented at: European Academy of Dermatology and Venereology (EADV) Congress; September 30-October 3, 2026; Vienna, Austria. Abstract LB-309.
2. Dika E, Scarfì F, Ferracin M, et al. Basal cell carcinoma: a comprehensive review. Int J Mol Sci. 2020;21(15):5572. doi:10.3390/ijms21155572
3. Bichakjian C, Armstrong A, Baum C, et al. Guidelines of care for the management of basal cell carcinoma. J Am Acad Dermatol. 2018;78(3):540-559.