Originally published by our sister publication Clinical Oncology News
The FDA approved nivolumab plus hyaluronidase-nvhy (Opdivo Qvantig, Bristol Myers Squibb) for subcutaneous injection across approved adult solid tumor nivolumab (Opdivo, Bristol Myers Squibb) indications as monotherapy, monotherapy maintenance following completion of nivolumab plus ipilimumab (Yervoy, Bristol Myers Squibb) combination therapy, or in combination with chemotherapy or cabozantinib.
The approval includes indications for 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. Nivolumab plus hyaluronidase-nvhy is not indicated in combination with IV ipilimumab.
The subcutaneous injection of nivolumab plus 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 randomized to receive either subcutaneous nivolumab plus hyaluronidase-nvhy or IV nivolumab.
The primary objective was to assess the nivolumab exposure of subcutaneous administration of nivolumab plus hyaluronidase-nvhy compared with IV nivolumab. The key secondary objective was to evaluate overall response rate (ORR), assessed by blinded independent central review. The trial met the predefined acceptance margin for pharmacokinetic end points, with the lower boundary of 90% CI of geometric mean ratios of not less than 0.8 for both serum nivolumab Cavg over 28 days and Cmin at steady state. ORR was 24% (95% CI,19%-30%) in the subcutaneous nivolumab plus hyaluronidase-nvhy arm and 18% (95% CI, 14%-24%) in the IV nivolumab arm.
In general, CheckMate 67T showed a similar safety profile between nivolumab plus hyaluronidase-nvhy and IV nivolumab. The most common adverse reactions (≥10%) were fatigue, musculoskeletal pain, pruritus, rash and cough.
The full prescribing information is posted here.
—Clinical Oncology News Staff
Based on a press release from the FDA.