On the sun-exposed faces of older adults, where skin cancer meets the mirror of identity, a new injectable therapy called BO-112 has offered a glimpse of a future where surgery is not always the first answer. Presented at a major European dermatology congress in Vienna, phase 2b trial results showed the drug clearing aggressive basal cell carcinomas—visibly and at the cellular level—in more than half of treated patients. The findings do not yet prove superiority over surgery, but they open a quieter question: how much of what we cut away might one day be dissolved from within.
Intralesional BO-112 Achieves 56% Complete Response Rate in High-Risk Head and Neck BCC
More than half of aggressive tumors responded completely, at the cellular level.
Mark
So this drug is injected directly into the tumor itself? That seems almost too simple.
Mimi
It is direct, yes. Three injections over three weeks, straight into the lesion. The drug activates the immune system to recognize and kill the cancer cells. What makes it interesting is that it worked in more than half of aggressive, high-risk cancers—the kind that are hardest to treat.
Luke
But here's the thing—all 50 patients still had surgery afterward. So we don't actually know if BO-112 alone can cure anyone. We know it can shrink tumors or clear them, but the study design required surgical removal at week 24.
Mimi
That's true, and Malvehy himself said you have to be cautious about phase 2 results. But the point is that when they removed the tissue and looked at it under a microscope, 56 percent of the high-risk head and neck cases showed complete pathological clearance. That's not just the tumor looking smaller—it was actually gone at the cellular level.
Mark
Why does it matter that these are on the face and neck specifically?
Mimi
Because surgery on the face leaves scars. It can affect how you look, how you smile, how you move. For a 75-year-old with a cancer on their nose, avoiding surgery or reducing how much tissue needs to be removed is a real quality-of-life issue.
Luke
The median age was 75, and 48 percent were women. So we're talking about a population that cares about appearance and may have other health issues that make surgery riskier. That context matters. But I want to flag that this is still a small trial—50 patients total, 40 with high-risk disease. Phase 3 will need to be much larger.
Mark
What about side effects?
Mimi
Remarkably mild. No serious adverse events. Most side effects were grade 1—basically inflammation at the injection site and minimal pain. 88 percent resolved within three days.
Luke
That's genuinely good news. But again, this is a short-term safety picture. We don't know long-term outcomes, recurrence rates, or how it compares to surgery in a head-to-head trial.
Mark
So what happens next?
Mimi
Phase 3. That's where they'll compare BO-112 to standard surgery and see if the responses hold up in a larger, more diverse population. If it works, it could change how dermatologists treat skin cancer on sensitive areas.
Luke
And that's the honest answer—we're still in the "promising" stage. The data is real and encouraging, but it's not yet proof that this replaces surgery or is better than surgery. That's what phase 3 will test.
Der Puls
- Basal cell carcinoma, the world's most common skin cancer, disproportionately strikes the face of aging patients, where surgical scars carry lasting cosmetic and functional consequences.
- BO-112, an immune-activating nanoparticle injected directly into tumors, achieved complete clinical and pathological responses in 56–62% of high-risk facial cases, including the notoriously stubborn infiltrative subtype.
- The drug's safety profile was strikingly clean—91% of side effects were mild, 88% resolved within three days, and no serious adverse events occurred across 50 trial participants.
- Because SPOTLIGHT-204 was a single-arm phase 2 trial with no surgical comparison group, its lead investigator urged caution, framing the results as promising but not yet practice-changing.
- The field now looks toward a phase 3 trial to determine whether BO-112 can replace surgery for some patients or serve as a tumor-shrinking prelude that reduces the extent of what must be removed.
On the sun-exposed faces of older adults, where skin cancer meets the mirror of identity, a new injectable therapy called BO-112 has offered a glimpse of a future where surgery is not always the first answer. Presented at a major European dermatology congress in Vienna, phase 2b trial results showed the drug clearing aggressive basal cell carcinomas—visibly and at the cellular level—in more than half of treated patients. The findings do not yet prove superiority over surgery, but they open a quieter question: how much of what we cut away might one day be dissolved from within.
This fall in Vienna, at the European Academy of Dermatology and Venereology Congress, dermatologist Josep Malvehy of Hospital Clínic of Barcelona presented results that quietly challenged one of skin cancer medicine's longest-standing assumptions: that surgery is always the answer.
The drug at the center of the story is BO-112, a double-stranded RNA nanoparticle that works by hijacking a tumor's own antiviral sensing pathways, causing cancer cells to die in a way that signals the immune system to finish the job. In the SPOTLIGHT-204 phase 2b trial, 50 patients with basal cell carcinoma received three weekly injections directly into their tumors before undergoing surgical removal four weeks later—a design that let researchers confirm whether what disappeared visually had also disappeared under the microscope. Among the 46 evaluable patients, 61% met that dual standard. For those with high-risk head and neck lesions, the complete response rate was 56%; for facial lesions specifically, 62%.
The stakes are personal for the patients most affected. Basal cell carcinoma grows most often on the nose, cheeks, and other features where surgery leaves marks that outlast the cancer itself. The median age in this trial was 75—a population for whom repeated or extensive operations carry real burden. Malvehy noted that even the most aggressive tumor subtype, infiltrative basal cell carcinoma, responded in more than half of cases, a result he described as genuinely surprising.
The safety data added to the optimism. No serious adverse events occurred. Ninety-one percent of side effects were grade 1, and 88% resolved within three days—a profile that compares favorably to other experimental intralesional therapies currently in development.
Malvehy was careful to frame the results within their limits. SPOTLIGHT-204 had no comparison group, and phase 2 trials are built to establish signal, not superiority. A phase 3 trial comparing BO-112 to standard surgical care will be necessary before the drug can reshape clinical practice. But the direction of travel is clear: an effective nonsurgical option, or even a therapy that reduces tumor size before surgery, would meaningfully change how dermatologists protect both the health and the faces of their patients.
A new injectable therapy has shown the ability to clear aggressive skin cancers on the face and neck without surgery in more than half of treated patients, according to results presented this fall at the European Academy of Dermatology and Venereology Congress in Vienna. The drug, called BO-112, was tested in a phase 2b trial called SPOTLIGHT-204 involving 50 patients with basal cell carcinoma—the most common form of skin cancer. Among the 40 patients with high-risk tumors, 58 percent achieved a complete response, meaning the cancer disappeared both visibly and at the cellular level when examined under a microscope. For the subset of 36 patients with aggressive cancers on the head and neck, the response rate climbed to 56 percent.
The appeal of this approach lies in where these cancers grow. Basal cell carcinomas frequently appear on the nose, cheeks, and other parts of the face where surgical removal can leave scars or affect how someone looks or functions. Surgery remains the standard treatment and works well, but it carries real consequences for patients, particularly older adults who make up the bulk of skin cancer cases. The median age in this trial was 75 years. Josep Malvehy, a dermatologist at Hospital Clínic of Barcelona who presented the findings, noted that intralesional therapy—injecting medication directly into the tumor—could eventually reduce the number of patients who need extensive surgical procedures. "Many of these cancers are appearing on the face and very sensitive cosmetic areas," he 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."
BO-112 works by activating the body's immune system. The drug is a double-stranded RNA nanoparticle that triggers antiviral sensing pathways within tumor cells, prompting them to die in a way that alerts the immune system to attack remaining cancer cells. Patients in the trial received three weekly injections directly into their tumors, then underwent surgical removal four weeks later. This design allowed researchers to verify that clinical responses—what doctors and patients could see—matched pathological responses confirmed by pathologists examining tissue samples under a microscope. Of the 46 patients evaluated, 61 percent achieved the primary endpoint of both visual and pathological response. Among patients with facial lesions specifically, 62 percent showed complete responses.
What surprised Malvehy and his colleagues was how well the drug worked against the most aggressive tumor types. Infiltrative basal cell carcinomas, which grow into surrounding tissue and are harder to treat, responded in more than 50 percent of cases. "They were responding in more than 50% of the cases. So we are really excited," Malvehy said after reviewing pathology reports with colleagues. The safety profile was equally encouraging. No serious adverse events occurred. Of all treatment-related side effects, 91 percent were mild—grade 1 on the standard toxicity scale—and 88 percent resolved within three days. Patients experienced some inflammation around the injection site and minimal pain, a significant advantage over other experimental intralesional therapies currently in trials.
Malvehy emphasized that these results must be interpreted carefully. SPOTLIGHT-204 was a single-arm trial, meaning there was no comparison group receiving standard surgery or placebo. Phase 2 trials are designed to test whether a drug works and is safe, not to prove it is better than existing treatments. "This is just a phase 2," he said. "Phase 2 means we don't have a comparative group versus surgery...so efficacy has always to be considered with caution." The next step is a phase 3 trial, which would compare BO-112 to standard care and involve more patients across more centers. Such a trial could determine whether the drug can eventually replace surgery for some patients or serve as a first step before surgery, reducing the extent of tissue that needs to be removed.
For dermatologists and patients, the potential is significant. Basal cell carcinoma affects hundreds of thousands of people each year, and the incidence is rising. Most cases occur on sun-exposed skin, particularly the face. While surgery works, it is not without burden—especially for older patients or those with multiple cancers. An effective nonsurgical option, or a therapy that could shrink tumors before surgery, would change how dermatologists approach treatment in cosmetically sensitive areas. Malvehy summed up the stakes: "This is a very promising, very positive result because we have so many patients that could benefit." The field now waits to see whether phase 3 data will support that optimism.
Bemerkenswerte Zitate
Many of these cancers are appearing on the face and very sensitive cosmetic areas. 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.— Josep Malvehy, MD, PhD, University of Barcelona and Hospital Clínic of Barcelona
This is just a phase 2. Phase 2 means we don't have a comparative group versus surgery...so efficacy has always to be considered with caution.— Josep Malvehy, MD, PhD
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