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Karl D. Lewis, MD


Oncolytic HSV-1 Plus Nivolumab in Head and Neck Non-Melanoma Skin Cancer

By: Kayci Reyer
Posted: Thursday, April 7, 2022

Research presented at the 2022 Multidisciplinary Head and Neck Cancers Symposium (Abstract 12) suggests that a combination therapy of the oncolytic virus RP1 and the checkpoint inhibitor nivolumab may prove to be a safe and effective treatment option for patients with non-melanoma skin cancer of the head and neck. Intratumoral RP1, an enhanced potency oncolytic herpes simplex virus type 1 (HSV-1), plus intratumoral nivolumab appeared to result in clinical responses for patients with cutaneous squamous cell carcinoma, angiosarcoma, Merkel cell carcinoma, or basal cell carcinoma.

“Responses have also been observed to be durable and to deepen over time,” noted Jiaxin Niu, MD, PhD, of the Banner MD Anderson Cancer Center, Gilbert, Arizona, and colleagues.

As of May 25, 2021, the phase II IGNYTE trial had enrolled 33 patients with non-melanoma skin cancer. Of them, 26 patients—15 with cutaneous squamous cell carcinoma, 4 with basal cell carcinoma, 4 with angiosarcoma, and 3 with Merkel cell carcinoma—have either had one or more postbaseline scans or died. As of June 6, 2021, patients with cutaneous squamous cell carcinoma had an interim objective response rate of 60%, a complete response rate of 46.6%, and a not-reached duration of response. The objective response rate varied across the remaining groups at 25%, 66%, and 75% for basal cell carcinoma, angiosarcoma, and Merkel cell carcinoma, respectively. PD-L1 and CD8 staining were observed to increase in tumor biopsies.

Fatigue, pruritus, constipation, decreased appetite, and nausea each occurred in more than 20% of patients. Dehydration and hypotension associated with RP1 treatment occurred as serious adverse events in two patients but resolved without long-term consequences. No deaths related to treatment occurred.

Disclosure: For full disclosures of the study authors, visit

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