ESMO 2025 | First line IO102-IO103 vaccine plus pembrolizumab in advanced melanoma
Ines Pires da Silva, MD, PhD, Melanoma Institute Australia, Sydney, Australia, explores the Phase III IOB-013/KN-D18 trial (NCT05155254) evaluating IO102-IO103, a cancer vaccine targeting IDO1+ and PD-L1+ cells with pembrolizumab as first-line therapy for advanced melanoma. The combination showed a clinically meaningful improvement in progression-free survival compared with pembrolizumab alone, including in PD-L1–negative patients, and was well tolerated without added systemic toxicity. Vaccine-specific T cells were significantly expanded, highlighting the potential of IO102-IO103 to enhance anti-tumor immune responses in advanced melanoma. This interview took place at the European Society for Medical Oncology (ESMO) 2025 Congress in Berlin, Germany.
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Transcript
So, first of all, I want to congratulate the authors because this is a very interesting study, but complex, okay? So, I’m going to start with that. So, I think it’s an immunomodulatory vaccine. So, differently from the, for example, personalized vaccines, if mRNA or peptide, those personalized, they target that specific tumor from that specific patient, right? We have the vaccines that target the tumor and the specific antigens...
So, first of all, I want to congratulate the authors because this is a very interesting study, but complex, okay? So, I’m going to start with that. So, I think it’s an immunomodulatory vaccine. So, differently from the, for example, personalized vaccines, if mRNA or peptide, those personalized, they target that specific tumor from that specific patient, right? We have the vaccines that target the tumor and the specific antigens. But differently from all this, this one, it will modulate the tumor microenvironment because it’s going to target any cell, tumor and non-tumor cells, so immunosuppressive cells that express a specific marker. In this case, it was IDO1 and PD-L1, okay? So that’s what I want to highlight. The second thing is this is a first-line study, so untreated patients, okay? Of course, patients who had neo-adjuvant or adjuvant treatment could be included as far as the time between finishing the adjuvant and neo-adjuvant and starting this trial was six months, okay? But keeping this in mind, this is first-line, it was the vaccine plus Pembrolizumab versus Pembrolizumab, okay? So that’s one thing. So the trial was not positive, okay? In a sense that, but literally, it was by a little bit that it missed, okay? And then they put the threshold of 0.65 of hazard ratio, which is a big gap, right? So that’s one thing. But the concept is there, and the difference is there, specifically for specific subgroups of patients, such as PD-L1 negative, BRAF-mutated melanomas, and patients with LDH above the upper normal limit. And if you think about this, this is the group of difficult patients to treat, meaning the patients that most likely will be resistant, right? So this is the group of patients that we are really interested in, the patients that we normally treat with Nivolumab plus Ipilimumab. So I find these results, even though it’s by definition a negative study, I find these results very compelling, specifically for this subgroup of patients.
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