Subcutaneous Opdivo demonstrated similar efficacy to intravenous administration for patients with kidney cancer.
Subcutaneous (SC) administration of Opdivo (nivolumab) was not inferior to intravenous (IV) delivery of the drug with regard to pharmacokinetics (the activity of the drug in the body over time) and response to the drug among some patients with kidney cancer, research has shown.
“More or less, [SC Opdivo] can achieve the same goals as intravenously administered [Opdivo],” said lead investigator Dr. Saby George, director of Network Clinical Trials and a professor of Oncology and Medicine at Roswell Park Comprehensive Cancer Center, as well as an associate professor at the Jacobs School of Medicine and Biomedical Sciences at the University of Buffalo. George and his colleagues recently published their findings in the Journal of Clinical Oncology.
Learn More: Injectable Opdivo May Mitigate Disparities in Kidney Cancer
A Study of Subcutaneous Versus Intravenous Opdivo
In a study of 495 patients with previously treated advanced or metastatic clear cell renal cell carcinoma, 248 patients (median age 64) received Opdivo subcutaneously, while 247 patients (median age 66) were treated intravenously.
The objective response rates (ORR; patients whose disease responded partially or completely to treatment) were 24.2% and 18.2% for the SC and IV cohorts, respectively, Median progression-free survival (the time until a patient’s disease spreads or worsens) times were 7.23 months and 5.65 months, respectively. Pharmacokinetics for the SC administration was also noninferior, researchers noted.
Researchers noted that injection site reactions occurred in 8.1% of the SC cohort but were “low grade and transient.” Drug toxicity resulted in three deaths in the SC cohort and one death in the IV cohort. Treatment-related side effects occurred in 24 and 36 patients in the SC and IV cohorts, respectively, and serious treatment-related side effects occurred in 16 patients in each cohort, according to the study.
“The co-primary [pharmacokinetics] and key powered secondary ORR endpoints were met, supporting the use of [Opdivo] SC as a new option to improve healthcare efficiency,” researchers wrote. “The safety profile for [Opdivo] SC was consistent with [Opdivo] IV.”
Injectable Opdivo Is ‘Easy on the Patient’
These findings indicate a potential major expansion of access to and utilization of treatment for patients.
“Subcutaneous administration takes only five minutes, while intravenous administration takes 30 to 60 minutes. So, that’s a big difference,” said George. “And it’s easy, the patients don’t need port placement or IV access for subcutaneous [Opdivo]. And so, it makes it easy on the patient, it makes it easy on the providers and the infusion center, etc. So, the infusion center can have chairs open up, because if these IV [Opdivo treatments] get transferred to outpatient administered subcutaneously [Opdivo], it opens up a lot of chair time.”
Opdivo is currently approved by the Food and Drug Administration for intravenous treatment in 22 indications across several cancer types, and the conversion to subcutaneous administration would save approximately 1,000 hours a year at Roswell Park, for example, George said.
“It allows for a lot of reduction in the wait time to get to chemotherapy,” George said. “So, patients are delayed because of the sheer volume at the centers. And if we can decompress infusion centers, they will have more availability.”
The switch to a simple subcutaneous injection would also allow Opdivo to be administered at more facilities, he noted.
“[For] patients, elderly patients, and patients who have difficulty getting to the infusion center, these can be made available closer to home,” George said. “If it’s in a clinic close to where they live, it can be administered there as opposed to having to drive to the big infusion center, it’s usually in a city or town.”
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