Originally published by our sister publication Clinical Oncology News
By Kate O’Rourke
Clinicians and patients may have an injectable form of the immunotherapy nivolumab (Opdivo, Bristol Myers Squibb) available in their future. A phase 3 study, CheckMate-67T, has shown that subcutaneous injection of nivolumab is noninferior to IV delivery and dramatically reduces treatment time in patients with renal cell carcinoma (RCC). The study findings were reported at the 2024 ASCO Genitourinary Cancers Symposium (abstract LBA360).
Because nivolumab is FDA approved for more than 20 indications across multiple cancer types, CheckMate-67T will likely spur trials of the subcutaneous formula in other patient populations.
According to trial leader and presenting study author Saby George, MD, a professor of oncology and medicine and the director of Network Clinical Trials at Roswell Park Comprehensive Cancer Center, in Buffalo, N.Y., the burden of treatment felt by patients with RCC is tremendous. “If nivolumab can be given as a subcutaneous injection instead of an intravenous infusion, [patients’] treatment experience will be significantly improved,” said Dr. George in a press statement. “Instead of one hour in an infusion chair, they will get the injection done in five minutes. If nivolumab becomes available subcutaneously, we can administer it in the clinic instead of sending patients to infusion centers.” The outcome could simultaneously speed treatment time for patients receiving nivolumab and shorten wait times for those who still need to receive treatment in an infusion center.
The availability of injectable nivolumab could also reduce health disparities, as patients who don’t live close to an infusion center could receive treatment at a clinic closer to home.
Study Details
The clinical trial randomized 495 patients at 73 centers in 17 countries. Roswell Park was one of three centers in the United States. Study participants had advanced or metastatic RCC, had received no more than two prior treatments with systemic therapies, and had not received prior immunotherapy. Patients were randomized in a 1:1 fashion to receive nivolumab either subcutaneously or intravenously.
The study’s primary objective was to evaluate the pharmacokinetics of subcutaneous versus IV delivery. Those measures included the daily average concentration of the drug in blood over 28 days and the drug concentration at the end of the dosing cycle. Both measures were noninferior to IV nivolumab, as evidenced in pharmacokinetic measures and overall response rate. The objective response rate for the subcutaneous group was noninferior to the IV group (24.2% vs. 18.2%, respectively). Median progression-free survival was 7.23 months for the subcutaneous arm and 5.65 months for the IV arm. The safety profile was similar in both groups.
Dr. George reported consulting or advisory roles with AstraZeneca, AVEO, Bayer, Bristol Myers Squibb, Eisai, EMD Serono, Exelixis, Merck, Novartis, Pfizer, QED Therapeutics, Sanofi and Seattle Genetics/Astellas.
