A subcutaneous injection of the immunotherapy nivolumab (brand name Opdivo) is inferior to intravenous delivery and dramatically shortens treatment time in patients with renal cell carcinoma, according to results of a large phase 3 clinical trial reported today at the 2024 American Society of Clinical Oncology. (ASCO) Genitourinary Cancer Symposium, San Francisco, California. Sabi George, MD, FACP, professor of oncology and medicine and director of the network clinical trial at Roswell Park Comprehensive Cancer Center, will provide a summary of the results of “A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Renal Carcinoma that Has Advanced or Spread (CHECMET-67T).” ” (NCT04810078).
“The burden of treatment experienced by cancer patients is extraordinary. If nivolumab can be given as a subcutaneous injection instead of an intravenous infusion, their treatment experience will be significantly improved,” said Dr. George, who is the presenting author, is a member of the clinical trial steering committee and the Roswell Park site principal investigator. “Instead of an hour in the infusion chair, they’ll complete the injection in five minutes.”
He points to the high demand for infusion chair appointments at most cancer centers, which can delay treatment by a week or more.
“If nivolumab is available, we can administer it in the clinic instead of sending patients to an infusion center.”
Sabi George, MD, FACP, Professor of Oncology and Medicine and Director of Network Clinical Trials, Roswell Park Comprehensive Cancer Center
This finding could simultaneously speed up treatment times for patients receiving nivolumab and shorten waiting times for patients who still need to receive treatment at an infusion center.
Availability of injectable nivolumab may also reduce health disparities. “A major problem is access to treatment,” said Dr. George, noted that some patients live a long distance from an infusion center and have no way to get there. “Patients who don’t live close to an infusion center can get treatment closer to home, in a clinic, and that can improve access and help reduce disparities.”
Sponsored by drugmaker Bristol Myers Squibb, the clinical trial began in May 2021, randomizing 495 patients at 73 centers in 17 countries. Roswell Park is one of only three participating sites in the United States and the only one in New York State.
Study patients had advanced or metastatic renal cell carcinoma, had received no more than two prior treatments with systemic therapy, and had received no prior immunotherapy. They were randomized 1:1 to receive nivolumab subcutaneously or intravenously. Nivolumab is FDA-approved and standard-of-care treatment for those patients.
The primary objective of the study was to evaluate the pharmacokinetics of subcutaneous vs. intravenous delivery; How the body interacted with nivolumab, including whether blood levels of the drug were comparable in the two groups over time. These measures included the daily average concentration of drug in blood over 28 days (Cavgd28) and the concentration of drug at the end of the dosing cycle (Cminss). Both regimens were inferior to intravenous nivolumab as evidenced by pharmacokinetic parameters and overall response rates.
Objective response rate for the subcutaneous group -; Percentage of patients who achieved a complete or partial response, measured by blinded independent central review -; 24.2% vs. proved non-inferior to the intravenous group. 18.2% respectively. Median progression-free survival stood at 7.23 months versus the subcutaneous group. 5.65 months for group IV. The safety profile was similar for both groups.
More than 80,000 new cases of renal cell carcinoma are diagnosed in the United States each year.
Because nivolumab is already FDA-approved for more than 20 indications across multiple malignancies, Checkmate-67T will likely serve as a gateway to additional studies evaluating the efficacy of the subcutaneous formulation in other patient populations.
“This is a breakthrough achievement for patients and physicians and will certainly make treatment easier for patients,” said Dr. George.