Videos

Dr Khushalani provides insights into real-world data that was recently discussed at ESMO 2022 assessing the use of cemiplimab in patients with advanced cSCC.

Real-World Data of Cemiplimab in Patients with Advanced cSCC

Nikhil Khushalani, MD, comments on updated data evaluating the use of cemiplimab in the neoadjuvant setting for patients with cSCC.

Role of Cemiplimab in the Neoadjuvant Setting for Patients with cSCC

An overview of treatment options for patients for with cSCC, focusing on the neoadjuvant setting.

Treatment Options for Patients with cSCC in the Neoadjuvant Setting

Dr Khushalani defines cutaneous squamous cell carcinoma (cSCC), reviews the risk factors associated, and explains the staging system for patients diagnosed with cSCC.

Overview of Cutaneous Squamous Cell Carcinoma (cSCC)

Nikhil Khushalani, MD, vise chair, Department of Cutaneous Oncology, Moffitt Cancer Center, discusses the mechanism of action vusolimogene oderparepvec (RP1) in cancer care.

RP1 is a next generation of talimogene laherparepvec (T-VEC; Imlygic), Khushalani says. RP1 is a selectively replication-specific herpes simplex virus-1 (HSV-1) for intertumoral injection, Khushalani says. What differentiates RP1 from T-VEC is the presence of a construct of HSV-1 where the neurovirulence factor gene has been deleted, allowing the virus to replicate within the tumor cells without harming normal cells through a bystander effect, Khushalani explains. Additionally, a granulocyte-macrophage colony-stimulating factor payload is encoded into RP1 to directly destroy tumors and generate an antitumor immune response, Khushalani adds.

RP1 also features an encoding codon for the glycoprotein, GALV-GP, with the deletion of the R sequence, Khushalani continues. This promotes cell-to-cell adhesion-related cytotoxicity, and tumor cells that are adjacent to one another when exposed to the agent undergo cytotoxic death, Khushalani concludes.

Nikhil Khushalani, MD, discusses the mechanism of action vusolimogene oderparepvec in cancer care.


Dr. Khushalani on the Mechanism of Action of RP1 in Cancer Care

Nikhil Khushalani, MD, vice chair, Department of Cutaneous Oncology, Moffitt Cancer Center, discusses the plans for the CA045-001 trial, an international, multicenter study that is comparing bempegaldesleukin (NKTR-214) plus nivolumab (Opdivo) versus nivolumab monotherapy in patients with previously untreated, unresectable, or metastatic melanoma.

This trial intends to accrue 764 patients globally in a 1:1 unblinded randomized fashion, explains Khushalani. In the initial 45 patients, a key endpoint is pharmacokinetics to understand how the body responds to and works with bempegaldesleukin.

After 480 patients are randomized, researchers will examine the overall response rate. Investigators are hopeful to increase the response rate by at least 21% compared with nivolumab alone. The co-primary endpoints are progression-free survival (PFS) and overall survival. This trial would be considered a success if the hazard ratio is met at 0.7, which means a 30% improvement on historical PFS with nivolumab by itself, according to Khushalani.

Nikhil Khushalani, MD, vice chair, Department of Cutaneous Oncology, Moffitt Cancer Center, discusses the plans for the CA045-001 trial, an international, multicenter study that is comparing bempegaldesleukin plus nivolumab versus nivolumab monotherapy in patients with previously untreated, unresectable, or metastatic melanoma.

Dr. Khushalani on Goals for the CA045-001 Trial in Melanoma

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.

Nikhil Khushalani, MD, discusses the CA045-001 study, a phase III, randomized study that compared bempegaldesleukin plus nivolumab versus nivolumab monotherapy in patients with previously untreated, unresectable, or metastatic melanoma.

Nikhil Khushalani, MD

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