Subcutaneous nivolumab as effective as IV for renal cell carcinoma, with much faster treatment time: Clinical trial (Better than IV)

Medical Xpress / 2024 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium ^ | Jan. 29, 2024 | Saby George, MD, FACP et al

[ConservativeMind]

Subcutaneous injection of the immunotherapy nivolumab (brand name Opdivo) is noninferior to intravenous delivery and dramatically reduces treatment time in patients with renal cell carcinoma, as seen in the results of a large phase 3 clinical trial reported today.

"The burden of treatment felt by cancer patients is tremendous. If nivolumab can be given as a subcutaneous injection instead of an intravenous infusion, their treatment experience will be significantly improved," says Dr. George. "Instead of one hour in an infusion chair, they will get the injection done in five minutes."

The clinical trial began in May 2021, randomizing 495 patients at 73 centers in 17 countries.

Patients in the study had advanced or metastatic renal cell carcinoma, had received no more than two prior treatments with systemic therapies and no prior immunotherapy. They were randomized 1:1 to receive nivolumab either subcutaneously or intravenously. Nivolumab is FDA-approved and the standard-of-care treatment for those patients.

The study's primary objective was to evaluate the pharmacokinetics of subcutaneous vs. intravenous delivery—how the body interacted with the nivolumab, including whether blood levels of the drug were comparable in the two groups over time. Those measures included the daily average concentration of the drug in the blood over 28 days (Cavgd28) and the concentration of the drug at the end of the dosing cycle (Cminss). Both measures were noninferior to intravenous nivolumab, as evidenced in pharmacokinetic measures and overall response rate.

The objective response rate for the subcutaneous group—the percentage of patients who achieved a complete or partial response, measured by blinded independent central review—proved noninferior to the intravenous group, at 24.2% vs. 18.2%, respectively. Median progression-free survival stood at 7.23 months for the subcutaneous group vs. 5.65 months for the IV group. The safety profile was similar for both groups.

[ConservativeMind]

Strangely, the results were fairly better than that of IV use.

When a Phase 3 trial is over, this generally means the medicine and its delivery method is available from at least select locations.

[ConservativeMind]

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