FDA Approves Subcutaneous Nivolumab Plus Hyaluronidase for Patients With Certain Solid Tumors

On December 27th, 2024, the US Food and Drug Administration (FDA) approved subcutaneous nivolumab plus hyaluronidase for adult patients with certain solid tumors including renal cell carcinoma, melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, urothelial carcinoma, colorectal cancer, hepatocellular carcinoma, esophageal carcinoma, gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. This approval was based on results from the phase 3 CHECKMATE-67T trial. 

In this multicenter, open-label trial, 495 patients with advanced or metastatic clear cell renal cell carcinoma who received no more than 2 prior lines of systemic treatment were randomized to receive either subcutaneous nivolumab plus hyaluronidase or intravenous nivolumab alone, until disease progression or unacceptable toxicity. The primary end point was nivolumab exposure in both treatment arms. Key secondary endpoints included overall response rate (ORR), which was assessed by blinded independent central review and safety. 

At analysis, the trial met the predefined acceptance margin for pharmacokinetic endpoints with the lower boundary of 90% confidence interval of geometric mean ratios of not less than 0.8 for both serum nivolumab Cavg over 28 days and Cmin at steady state. The ORR was 24% in the subcutaneous nivolumab plus hyaluronidase arm and 18% in the intravenous nivolumab arm. The safety profile was consistent across both treatment arms. The most common adverse reactions occurring in ≥ 10% of patients included fatigue, musculoskeletal pain, pruritus, rash, and cough. 

The recommended dose depends on the specific indication. It is either 600 mg of nivolumab plus 10,000 units of hyaluronidase every 2 weeks, 900 mg of nivolumab plus 15,000 units of hyaluronidase every 3 weeks, or 1,200 mg of nivolumab plus 20,000 units of hyaluronidase every 4 weeks until disease progression, unacceptable toxicity, or as indicated in the prescribing information. 

Source:

FDA approves nivolumab and hyaluronidase-nvhy for subcutaneous injection. Accessed on December 27, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-and-hyaluronidase-nvhy-subcutaneous-injection