The subcutaneous injection of the immunotherapeutic agent Nivolumab (brand name Opdivo) has been shown to be non-inferior to intravenous administration and significantly shortens the treatment time for patients with renal cell carcinoma, according to the results of a large phase 3 clinical study reported today at the American Society of Clinical Oncology 2024 Genitourinary Cancers Symposium in San Francisco, California. Saby George, MD, FACP, Professor of Oncology and Medicine and Director of Network Clinical Trials at Roswell Park Comprehensive Cancer Center, will present an oral summary detailing the results from „A Study of Subcutaneous Nivolumab versus Intravenous Nivolumab in Participants with Previously Treated Clear Cell Renal Cell Carcinoma that is Advanced or Metastatic (CheckMate-67T)“ (NCT04810078).
„The treatment burden for cancer patients is enormous. If Nivolumab can be administered as a subcutaneous injection instead of an intravenous infusion, it will significantly improve their treatment experience,“ says Dr. George, lead author and member of the clinical studies steering committee at Roswell Park. „Instead of an hour in the infusion chair, the injection is done in five minutes.“
He points out the high demand for infusion chair appointments in most cancer centers, leading to treatment delays of a week or more.
„By making Nivolumab available subcutaneously, we can administer it in the clinic rather than sending patients to infusion centers.“
Saby George, MD, FACP, Professor of Oncology and Medicine and Director of Network Clinical Trials, Roswell Park Comprehensive Cancer Center
This result could simultaneously reduce treatment time for patients receiving Nivolumab and shorten wait times for patients still needing treatment at an infusion center.
The availability of injectable Nivolumab could also reduce health disparities. „One of the biggest issues is access to treatment,“ says Dr. George, pointing out that some patients live far from an infusion center and have no means of getting there. „Patients who don’t live near an infusion center could be treated closer to home, in a clinic, which could improve access and help reduce disparities.“
The clinical study, sponsored by Bristol Myers Squibb, the manufacturer of the drug, began in May 2021 and involved 495 patients at 73 centers in 17 countries. Roswell Park was one of only three participating sites in the United States and the only one in the state of New York.
The patients in the study had advanced or metastatic renal cell carcinoma, had received no more than two prior treatments with systemic therapies, and had not previously received immunotherapy. They were randomized in a 1:1 ratio and received Nivolumab either subcutaneously or intravenously. Nivolumab is FDA-approved and the standard treatment for these patients.
The main objective of the study was to evaluate the pharmacokinetics of subcutaneous vs. intravenous administration, assessing how the body interacted with Nivolumab, including whether blood levels of the drug were comparable in both groups over time. These measurements included the average daily concentration of the drug in the blood over 28 days (Cavgd28) and the drug concentration at the end of the dosing cycle (Cminss). Both measures were non-inferior to intravenously administered Nivolumab, as evidenced by the pharmacokinetic measurements and overall response rate.
The objective response rate for the subcutaneous group – the percentage of patients who achieved a complete or partial remission, measured by a blinded, independent central review – proved to be non-inferior to the intravenous group at 24.2% and 18.2%, respectively. The median progression-free survival was 7.23 months for the subcutaneous group compared to 5.65 months for the IV group. The safety profile was similar for both groups.
Each year, more than 80,000 new cases of renal cell carcinoma are diagnosed in the United States.
Since Nivolumab is already FDA-approved for more than 20 indications in various malignancies, CheckMate-67T is likely to serve as a gateway to further studies evaluating the effectiveness of the subcutaneous formulation in other patient groups.
„This is a groundbreaking achievement for patients and physicians and will certainly make treatment easier for patients,“ says Dr. George.
Roswell Park Comprehensive Cancer Center