Subcutaneous Nivolumab Noninferior to IV Version in ccRCC

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Findings from the CheckMate -67T (NCT04810078) reported that subcutaneous nivolumab (Opdivo) co-formulated with human hyaluronidase (rHUPH20) met its co-primary pharmacokinetic end points and key secondary end point of overall response rate (ORR) compared with intravenous (IV) nivolumab for the treatment of patients with clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapies.¹

Subcutaneous nivolumab demonstrated noninferior performance of time-averaged nivolumab serum concentration over 28 days and steady-state trough serum concentration compared with IV nivolumab. Subcutaneous nivolumab also showed a noninferior ORR compared with IV nivolumab.

“Intravenous [nivolumab] has helped transform the treatment of several solid tumor types over the past decade, but there remains a need for additional administration options to address treatment burden on patients and improve efficiencies in healthcare systems,” said Gina Fusaro, PhD, vice president, global program lead, Bristol Myers Squibb, in a press release. “We believe this new option, given as a single injection administered in less than 5 minutes, could transform the treatment experience for both patients and physicians.”¹

The phase 3, open-label, randomized, noninferiority trial has an estimated enrollment of 454 patients. To be eligible, patients must have a histological confirmation of ccRCC, advanced RCC not amenable to curative or radiation therapy, metastatic RCC, received no more than 2 prior systemic therapies, intolerance or progression after last treatment regimen within 6 months of randomization, and Karnofsky performance score ≥ 70 at screening.

Patients are not eligible if they have untreated central nervous system metastases, a concurrent malignancy, active or suspected autoimmune disease, known HIV-positive status with an acquired immunodeficiency syndrome, or a serious or uncontrolled medical disorder. Patients who have received prior treatment with an anti-PD-1, anti-PD-LI, or anti-CTLA-4 antibody, or treatment with any live attenuated vaccine within 30 days of randomization are also not eligible to enroll in the study.²

Bristol Myers Squibb, nivolumab’s manufacturer, will complete a full analysis and evaluation of the available data from the CheckMate -67T and work with investigators to present results at an upcoming medical conference. Trial follow-up is ongoing and will assess additional secondary safety and efficacy end points.¹

REFERENCES:

1. Phase 3 Check-Mate -67T trial of subcutaneous nivolumab (nivolumab and hyaluranisade) meets co-primary end points in advanced or metastatic clear cell renal cell carcinoma. News release. Bristol Myers Squibb. October 19, 2023. Accessed October 19, 2023. https://tinyurl.com/4sryy6vh

2. A study of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread (CheckMate-67T). ClinicalTrials.gov. Updated October 12, 2023. Accessed October 19, 2023. https://www.clinicaltrials.gov/study/NCT04810078