The U.S. Food and Drug Administration (FDA) approved nivolumab and hyaluronidase-nvhy (Opdivo Qvantig, Bristol Myers Squibb company) for solid tumors includes melanoma, head and neck squamous cell carcinoma, renal cell carcinoma, hepatocellular carcinoma, gastroesophageal junction cancer, urothelial carcinoma, non-small cell lung cancer, esophageal adenocarcinoma, hepatocellular carcinoma, colorectal cancer, gastric cancer, and esophageal carcinoma.
This approval medication administrated in the form of subcutaneous injection applies across approved adult, solid tumor nivolumab (Opdivo, Bristol Myers Squibb company) as monotherapy. It is also used as maintenance medication after completion of Opdivo (nivolumab) plus Yervoy (ipilimumab) combination therapy. Additionally, it is also used in combination therapy with carbozantinid or chemotherapy. It is not recommended for intravenous ipilimumab combination therapy.
CHECKMATE-67T (NCT04810078) clinical trial was conducted to determine the efficacy and safety of Opdivo Qvantig subcutaneous injection. This trial is a multi-center, randomized, and open-label study. The primary objective was to assess intravenous novolumab compared to subcutaneous Opdivo Qvantig whereas secondary objective to calculate overall response rate (ORR) by blind independent central review (BICR).
Patients with advanced or metastatic clear cell renal cell carcinoma who had undergone no more than 2 prior systemic treatments were included. Patients with concurrent cancer require treatment, history of prior cancer active within 2 years, autoimmune disease (Active/known/suspected), human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) were excluded.
Four hundred and ninety-five patients were selected and randomized to take nivolumab intravenously (nivolumab arm) or nivolumab and hyaluronidase-nvhy subcutaneously (Opdivo Qvantig arm). This clinical trial achieved the predefined pharmacokinetic parameters. The serum concentrations of nivolumab including Cavg over 28 days and Cmin at steady state were observed at 90% confidence interval (CI) of geometric mean ratios of ≥0.8. Moreover, ORR was 24% (95% CI: 19,30) and 18% (95% CI: 14,24) observed in the Opdivo Qvantig arm and nivolumab arm, respectively.
Similar safety measures were observed between Opdivo Qvantig arm and nivolumab arm in this clinical study. In general, ≥10% of adverse events such as musculoskeletal pain, fatigue, pruritus, rash, hypothyroidism, diarrhea, cough, and abdominal pain were reported.
The prescribed dosage on the type of solid tumor indication. This recommendation includes either 600 mg nivolumab and 10,000 units hyaluronidase every 2 weeks; 900 mg nivolumab and 15,000 units of hyaluronidase every 3 weeks or 1,200 mg nivolumab and 20,000 units hyaluronidase every 4 weeks till progression of disease, occurrence of undesirable side effects or toxicity, or as specified in the prescribing information.
Opdivo Qvantig is a combination of a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death-receptor 1 (PD-1) or the PD-ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thus eliminating inhibition of the immune response, possibly breaking peripheral tolerance, and encouraging immune mediated adverse responses, and an endoglycosidase used to enhance the dispersion and absorption of co-administered drugs when administered subcutaneously. While immune-mediated adverse responses normally manifest during treatment with PD-1/PD-L1 blocking antibodies, immune-mediated adverse reactions can also manifest after discontinuation of PD-1/PD-L1 blocking antibodies.
Early identification and management of immune-mediated adverse reactions are needed to ensure safe use of PD-1/PD-L1 blocking antibodies. Observe patients closely for signs and symptoms and measure liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of any suspected adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.
Reference: Food and Drug Administration (FDA). FDA approves nivolumab and hyaluronidase-nvhy for subcutaneous injection. 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-and-hyaluronidase-nvhy-subcutaneous-injection
