Amongst sufferers with treatment-naïve superior melanoma, therapy with the investigational immune-modulatory therapeutic most cancers vaccine IO102-IO103 plus Keytruda (pembrolizumab) has been discovered to be related to a clinically significant enchancment in median progression-free survival (PFS) in contrast with Keytruda alone in sufferers with treatment-naïve superior melanoma, based on information from the section 3 IOB-013/KN-D18 trial introduced in the course of the 2025 ESMO Congress in Berlin.
“These information assist the potential advantage of this immune-modulatory most cancers vaccine together with pembrolizumab for sufferers with untreated, superior melanoma,” acknowledged Dr. Jessica C. Hassel, in her presentation of the findings on the assembly.
Hassel works within the Division of Dermatology at Heidelberg College, in addition to on the Nationwide Centre for Tumor Illnesses in Heidelberg, Germany.
Glossary
Development-free survival (PFS): That is the size of time a affected person lives with most cancers with out the illness getting worse or “progressing.”
Total response fee (ORR): That is the proportion of sufferers whose most cancers considerably shrinks or disappears fully after receiving a particular therapy.
Total survival (OS): That is the median or common size of time from the beginning of a scientific trial or therapy that sufferers with a particular most cancers are nonetheless alive.
Length of response (DOR): That is the size of time {that a} affected person’s most cancers continues to shrink or keep secure after a therapy has achieved a response.
After a median follow-up of roughly two years, the mix of IO102-IO103 and Keytruda improved median PFS by 8.4 months in contrast with Keytruda monotherapy. Median PFS within the experimental arm was 19.4 months versus 11 months for Keytruda alone. Though the pre-specified statistical significance threshold was not met, the PFS enchancment favored the mix routine throughout all predefined subgroups.
Amongst sufferers with PD-L1–detrimental illness, the median PFS was 16.6 months with the mix versus three months with Keytruda alone.
Moreover, the general response fee (ORR) was 44.8% within the vaccine arm and 41.2% within the Keytruda monotherapy arm.
Security Findings from the Part 3 IOB-013/KN-D18 Trial
It was additional reported that the mix routine didn’t end in an elevated frequency of immune-mediated or treatment-related unwanted side effects in contrast with Keytruda monotherapy.
Immune-mediated unwanted side effects occurred in 34% of sufferers receiving the mix versus 38.4% receiving Keytruda alone, and grade 3 (extreme) or increased treatment-related unwanted side effects occurred in 14.5% and 15.6% of sufferers, respectively. Injection-site reactions associated to the vaccine have been predominantly reported to be grades 1 (gentle) and a pair of (average) in severity.
IO102-IO103 Mechanism of Motion
IO102-IO103, Hassel defined, is an off-the-shelf immune-modulatory most cancers vaccine designed to focus on each tumor cells and immune-suppressive cells throughout the tumor microenvironment. The vaccine stimulates activation and growth of T cells towards IDO1-positive and PD-L1–constructive cells, enhancing antitumor immune exercise.
IOB-013/KN-D18 Trial Design, Affected person Eligibility and Extra Efficacy Outcomes
The section 3 IOB-013/KN-D18 trial enrolled 407 sufferers with treatment-naïve superior melanoma throughout roughly 100 world websites. Sufferers have been randomized to obtain both subcutaneous IO102-IO103 (85 μg of every part) together with Keytruda (200 mg intravenously each three weeks; 203 sufferers) or Keytruda alone (204 sufferers) for as much as two years.
The first finish level was PFS, with an information cutoff of Could 30, 2025. Secondary finish factors included total survival (OS), ORR by BICR, length of response (DoR), and security. Vaccine-specific immune response in peripheral blood mononuclear cells served as an exploratory finish level.
Eligible sufferers had unresectable stage 3 or metastatic stage 4 melanoma, measurable illness, and an ECOG efficiency standing of 0 or 1. Prior adjuvant or neoadjuvant remedy was permitted if the final dose occurred greater than six months earlier than examine entry. Sufferers with secure central nervous system (CNS) illness have been eligible.
Baseline demographics and illness traits have been balanced between therapy arms. The median age was 71 years within the mixture arm and 69 years within the Keytruda-alone arm. Most sufferers have been male (mixture, 67%; Keytruda-alone, 58.8%) and had cutaneous melanoma (86.2%; 85.3%). PD-L1 positivity was noticed in 63.5% and 62.3% of sufferers within the respective arms.
In line with ClinicalTrials.gov, the trial started in Could 2022 and reached its main completion in Could 2025. The examine is predicted to conclude in September 2027.
References
- “LBA53 – IO102-IO103 most cancers vaccine plus pembrolizumab for first-line (1L) superior melanoma: Main section III outcomes (IOB-013/KN-D18),” by Dr. Jessica C. Hassel et al., introduced on the European Society for Medical Oncology (ESMO) Congress 2025; October 17-21, 2025; Berlin, Germany. Summary LBA53.
- “IO102-IO103 in Mixture With Pembrolizumab Versus Pembrolizumab Alone in Superior Melanoma (IOB-013 / KN-D18), clinicaltrials.gov.,” accessed Oct. 20, 2025; https://clinicaltrials.gov/examine/NCT05155254
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