OPDIVO (nivolumab) is an intravenous treatment often used in conjunction with YERVOY (ipilimumab) for advanced renal cell carcinoma (RCC), though it can be used on its own.
Researchers became interested in whether alternate OPDIVO formulations could show promise for advanced or metastatic clear cell RCC. This RCC subtype accounts for approximately 80% of renal cell carcinoma cases and is named for the presentation of cells under a microscope, which are clear and bubble-like.
This question led to the Phase 3 CheckMate -67T study. Within the study, researchers evaluated the safety, efficacy, and pharmacokinetics of intravenous nivolumab vs. subcutaneous nivolumab co-formulated with recombinant human hyaluronidase. Specifically, the researchers focused on the impact on individuals who had received prior systemic therapy.
Subcutaneous or Intravenous: Which Modality is Stronger?
A late January 2024 news release from Bristol Myers Squibb (BMS) covered newly disclosed topline data from the study. 495 people enrolled. The group was split into two cohorts: one which received subcutaneous OPDIVO and the other which received intravenous OPDIVO. From there, researchers analyzed time-averaged serum concentration over 28 days (Cavgd28) and trough serum concentration at steady-state (Cminss). The study found that subcutaneous OPDIVO showed noninferiority in Cavgd28 and Cminss, as well as the objective response rate, which refers to how many people responded (in any way) to treatment.
In terms of progression-free survival, rates were slightly higher in the group receiving subcutaneous OPDIVO. Those in the subcutaneous group had an average progression-free survival of 7.23 months compared to 5.65 months for the intravenous formulation. Finally, both subcutaneous and intravenous OPDIVO were similarly safe. More common side effects included injection-site reactions. Serious and/or treatment-related adverse reactions were slightly more common in the intravenous group.
OPDIVO is also used to treat other oncological conditions. These include unresectable or metastatic melanoma, resected stage IIB-IV melanoma; resectable non-small cell lung cancer; metastatic NSCLC without EGFR or ALK mutations; metastatic NSCLC that has progressed while using chemotherapy; unresectable malignant pleural mesothelioma; relapsed or progressed Hodgkin’s lymphoma; recurrent or metastatic squamous cell carcinoma of the head and neck; advanced or metastatic urothelial carcinoma; MSI-H or dMMR metastatic colorectal cancer; sorafenib-treated hepatocellular carcinoma; recurrent or metastatic esophageal squamous cell carcinoma; and resected esophageal or gastroesophageal junction cancer, among others. Learn more about OPDIVO.
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Identifying Renal Cell Carcinoma (RCC): What You Should Know
Also known as: Conventional renal cell carcinoma
Renal cell carcinoma is a form of kidney cancer that begins in small tubes called tubules in the kidneys. It usually forms in one kidney but can be found in both. Clear cell RCC is the most common form; rarer subtypes include papillary and chromophobe. Renal cell carcinoma is the most common form of kidney cancer in adults, and most often affects people between 50 to 70 years old. It is also more common in males and people who smoke.
Renal cell carcinoma develops without causing symptoms in early stages. As it progresses, symptoms may include hematuria (blood in the urine), persistent abdominal or side/back pain, an abdominal lump, fatigue, intermittent fever, losing weight without meaning to, enlarged testicle or varicose testis vein, high blood pressure, and vision abnormalities.
Available treatments for RCC include chemotherapy, ablation, hormone treatments, Nexavar, OPDIVO, Proleukin, Afinitor, and surgical removal of the kidney, bladder, and affected tissue. However, the 5-year survival rate for advanced RCC is just 14%. Early detection and treatment are crucial for improving outcomes, as is the development of therapeutics for those with advanced disease.
clear renal cell carcinoma research
Last modified: February 28, 2024
