Dr. Pavlick on the IGNYTE Trial in Patients With Melanoma Following Anti–PD-1 Progression

Anna C. Pavlick, DO, professor of medicine, the Division of Hematology and Medical Oncology, Weill Cornell Medicine, founding director, the Cutaneous Oncology Program, Weill Cornell Medicine and New York-Presbyterian, discusses the phase 2 IGNYTE trial (NCT03767348) examining vusolimogene oderparepvec (RP1), an oncolytic vaccine based on a proprietary new strain of herpes simplex virus, in combination with nivolumab (Opdivo) in 3 tumor-specific cohorts, including 1 featuring patients with anti–PD-1–failed cutaneous melanoma.

The IGNYTE trial began as a phase 2 study, and investigators added an expansion arm investigating the combination of RP1 and nivolumab in patients with cutaneous melanoma, Pavlick begins. The expansion cohort aimed to enroll 125 patients with cutaneous melanoma who progressed on anti–PD-1 therapy, and data from the first 75 patients treated in the expansion cohort who had at least 6 months of follow-up. All patients in this group were pretreated with anti–PD-1 therapy and needed to have confirmation that they progressed while on anti–PD-1 therapy, Pavlick notes.

Among these 75 patients, the overall response rate was 36%, including a complete response (CR) rate of 20%. These responses were consistent with initial data from the trial, which showed that 16 patients with cutaneous melanoma experienced an ORR of 37.5% and a CR rate of 12.5%. Approximately half of patients in the expansion cohort have experienced a CR, partial response, or stable disease, Pavlick continues.

Given that these patients progressed on a prior anti–PD-1 agent, the number of complete responders to the combination of RP1 and nivolumab was impressive, Pavlick concludes.