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Soo Park, MD
Soo Park, MD
Posted: Monday, December 2, 2024
Use of the combination of the Toll-like receptor 9 (TLR9) agonist vidutolimod and the PD-1 inhibitor nivolumab before surgery may improve outcomes in patients with stage III cutaneous melanoma, based on a prospective phase II trial published in the journal Cancer Cell. Lead study author Diwakar Davar, MD, of the University of Pittsburgh Medical Center Hillman Cancer Center, and colleagues, believe their research findings provide insights that may advance research on this combination immunotherapy for use in cutaneous melanoma as well as other cancer types.
“This is the first and only clinical trial so far to test the novel combination of nivolumab and the experimental drug vidutolimod in the neoadjuvant setting,” stated Dr. Davar in an institutional press release. “It’s exciting that we saw a response rate of 55%, which is on par with currently approved immunotherapy combinations.”
In this study, 31 patients with high-risk, resectable stage III cutaneous melanoma were assigned to receive seven injections of vidutolimod into their tumors and three rounds of intravenous nivolumab prior to surgery. Following surgery, they continued to receive both drugs every 4 weeks for 1 year.
After presurgical therapy, the patients who responded to treatment (55%) had less than 10% of viable tumor cells remaining—which previous research has shown to be a good predictor of long-term survival in this patient population. In the patients with the greatest responses to the combination therapy, the 2-year recurrence-free survival and metastasis-free survival rates were 88% and 94%, respectively.
After comparing tumors and blood from the highest responding patients with those who didn’t respond as well, the researchers found that plasmacytoid dendritic cells and myeloid cells were enriched in the former compared with the latter. Neither plasmacytoid dendritic cells nor myeloid cells are typically enriched in patients treated with nivolumab alone, so these observations revealed that vidutolimod may have stimulated antitumor immunity in a unique way.
Disclosure: For full disclosures of the study authors, visit cell.com.
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