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Soo Park, MD
Soo Park, MD
Posted: Tuesday, September 27, 2022
Dual checkpoint inhibition with nivolumab and ipilimumab may prove to be a viable first-line and salvage therapy alternative for some patients with advanced Merkel cell carcinoma. According to Sungjune Kim, MD, of H. Lee Moffitt Cancer Center, University of South Florida, and colleagues, the combination resulted in high overall response rates in immune checkpoint inhibitor–naive patients as well as clinical benefits in patients previously treated with anti–PD-1 and PD-L1 therapy. These findings from this phase II clinical trial were presented at the European Society for Medical Oncology (ESMO) Annual Congress 2022 (Abstract LBA42) and published in The Lancet.
“In this study, first-line therapy with nivolumab plus ipilimumab in patients with advanced Merkel cell carcinoma demonstrated an exceptionally high overall response rate of 100%, with durable responses and a manageable safety profile,” the authors concluded.
The randomized, open label trial enrolled patients with unresected, recurrent, or stage IV Merkel cell carcinoma with at least two measurable tumor lesions. Patients in arm A received 240 mg of intravenous nivolumab every 2 weeks plus 1 mg/kg of intravenous ipilimumab every 6 weeks. Patients in arm B received the same schedule of nivolumab plus ipilimumab and additional stereotactic body radiation therapy to 24 Gy in three fractions during week 2 of treatment.
By December 2021, 50 patients (25 in each arm) were enrolled in the study. Arm A included 13 immune checkpoint inhibitor–naive patients, and arm B included 11. All immune checkpoint inhibitor–naive patients had a confirmed objective response (complete or partial response), with 41% being a complete response. The confirmed objective response in patients with previous exposure to an immune checkpoint inhibitor was 31%, with 15% being a complete response. Objective response rates between the two arms were not significantly different (P = .26). Grade 3 or 4 treatment-emergent adverse events were reported in 40% of patients in arm A and 32% of patients in arm B.
Disclosure: For full disclosures of the study authors, visit oncologypro.esemo.org.
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