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Soo Park, MD
Soo Park, MD
Posted: Friday, February 7, 2025
The U.S. Food and Drug Administration (FDA) approved nivolumab and hyaluronidase-nvhy (Opdivo Qvantig) for subcutaneous injection across approved adult, solid tumor nivolumab indications—including unresectable or metastatic melanoma—as monotherapy, monotherapy maintenance following completion of nivolumab plus ipilimumab, or in combination with chemotherapy or cabozantinib. This treatment is a combination of the PD-1–blocking antibody nivolumab and the endoglycosidase hyaluronidase. The announcement was made late in 2024.
The subcutaneous injection of nivolumab and hyaluronidase-nvhy was evaluated in CheckMate-67T (ClinicalTrials.gov identifier NCT04810078), a multicenter, randomized, open-label trial in patients with advanced or metastatic clear cell renal cell carcinoma who received no more than two prior systemic treatment regimens. A total of 495 patients were randomly assigned to receive either subcutaneous nivolumab and hyaluronidase-nvhy or intravenous nivolumab.
The trial met the predefined acceptance margin for pharmacokinetic endpoints. The objective response rate was 24% (95% confidence interval [CI] = 19%–30%) with subcutaneous nivolumab and hyaluronidase-nvhy and 18% (95% CI = 14%–24%) with nivolumab administered intravenously. In general, in this trial, a similar safety profile was observed between nivolumab and hyaluronidase-nvhy and intravenous nivolumab. The most common adverse reactions (≥ 10%) were fatigue, musculoskeletal pain, pruritus, rash, and cough.
The recommended dosage depends on the specific indication and is either 600 mg of nivolumab and 10,000 units of hyaluronidase every 2 weeks; 900 mg of nivolumab and 15,000 units of hyaluronidase every 3 weeks; or 1,200 mg of nivolumab and 20,000 units of hyaluronidase every 4 weeks until disease progression, unacceptable toxicity, or as indicated in the prescribing information.
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