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Soo Park, MD
Soo Park, MD
Posted: Thursday, September 19, 2024
A combination of the CD40 agonist sotigalimab with the PD-1 inhibitor pembrolizumab may clinically benefit patients with metastatic melanoma, according to Adi Diab, MD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues. In fact, they reported, sotigalimab plus pembrolizumab was well tolerated and produced good clinical outcomes in this patient population. The findings of this phase I/II study were presented at the European Society for Medical Oncology (ESMO) Congress 2024 (Abstract 71MO).
“While checkpoint inhibitors provide significant clinical benefit for patients with metastatic melanoma, many still develop treatment resistance,” according to an MD Anderson press release. “[This] study demonstrated that sotigalimab effectively engaged the CD40 pathway, boosting the infiltration and activation of antigen-presenting cells, [and] was well tolerated and safe....”
A total of 32 patients with untreated metastatic melanoma received sotigalimab intratumoral injections in combination with pembrolizumab therapy. Gene-expression analysis and multiplex immunofluorescence imaging were used to evaluate the local immune response using 23 matched tumor biopsies obtained before and 24 hours after treatment. Single-cell multiome profiling was used to identify immune cell activation. T-cell receptor sequencing addressed T-cell clonality.
With the recommended phase II dose of sotigalimab, the objective response rate was 50%, with a disease control rate of 91%. The combination was reported to be well tolerated, with injection-site reactions, pruritus, and fatigue as the most common adverse events. Local and distant tumors both exhibited an increase in T-cell clonality and shared new clones. The alterations in T-cell clonality were found to be associated with clinical response.
Disclosure: The study authors reported no conflicts of interest.
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