Dr. Khushalani on Reasoning for the CA045-001 Trial

Nikhil Khushalani, MD, vice chair, Department of Cutaneous Oncology, Moffitt Cancer Center, discusses the CA045-001 study, a phase III, randomized study that compared bempegaldesleukin (NKTR-214) plus nivolumab (Opdivo) versus nivolumab monotherapy in patients with previously untreated, unresectable, or metastatic melanoma.

Aldesleukin (Proleukin) has been around for 20 years and is approved for the treatment of patients with advanced melanoma; however, the agent is limited by its toxicity and is therefore unable to be used in many patients, according to Khushalani. Response rates have traditionally been 14% to 15%, though some of the responses have been long-lasting. Bempegaldesleukin is a modified version of aldesleukin that provides more tumor-infiltrating lymphocytes, Khushalani explains.

Nivolumab, an anti—PD-1 agent, alone is a standard of care. The response rates to nivolumab by itself are approximately 40%, Khushalani says. The hope, according to Khushalani, is that the combination will offer more efficacy with less toxicity.