The U.S. Food and Drug Administration (FDA) has granted approval to Bristol Myers Squibb's Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) for subcutaneous injection, marking a significant advancement in cancer immunotherapy. This new formulation offers a more convenient and faster administration method for adult patients with various solid tumors. Opdivo Qvantig is approved for use as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib. However, it is not indicated for use in combination with intravenous ipilimumab.
Clinical Trial Data Supporting Approval
The FDA's decision was primarily based on the results of the Phase 3 CheckMate-67T trial, a randomized, open-label, non-inferiority study. This trial compared Opdivo Qvantig to intravenous Opdivo in 495 adult patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who had previously received systemic therapy. The study demonstrated that Opdivo Qvantig achieved non-inferior co-primary pharmacokinetic (PK) exposures and similar efficacy in overall response rate (ORR), while maintaining a comparable safety profile to intravenous Opdivo.
Specifically, the geometric mean ratios (GMRs) for time-averaged concentration over 28 days (Cavgd28) was 2.10 (90% CI: 2.00-2.20), and the GMR for minimum concentration at steady state (Cminss) was 1.77 (90% CI: 1.63-1.93). As a key powered secondary endpoint, the overall response rate (ORR) in the Opdivo Qvantig arm (n=248) was 24% (95% CI: 19-30) compared with 18% (95% CI: 14-24) in the IV Opdivo arm (n=247), showing that Opdivo Qvantig has similar efficacy compared to IV Opdivo as assessed by Blinded Independent Central Review (BICR).
Enhanced Patient Convenience and Treatment Flexibility
One of the key advantages of Opdivo Qvantig is its significantly reduced administration time. The subcutaneous injection takes only three to five minutes, compared to the 30-minute intravenous infusion required for traditional Opdivo. This faster administration may offer greater flexibility for patients and healthcare providers, potentially reducing the time and resources needed for treatment.
Professor Dr. Saby George, MD, FACP, medical oncologist and director of network clinical trials at Roswell Park Comprehensive Cancer Center, noted, "This approval of subcutaneous nivolumab gives our patients a new option that can deliver consistent efficacy and comparable safety expected from IV nivolumab, and offers a patient-centric treatment experience. Opdivo Qvantig offers faster administration, delivered in three to five minutes. It may allow patients, in consultation with their doctors, to choose another treatment method and the flexibility to receive treatment closer to home."
Safety Profile
The safety profile of Opdivo Qvantig was found to be consistent with that of intravenous Opdivo. In the CheckMate-67T trial, serious adverse reactions occurred in 28% of patients receiving Opdivo Qvantig. The most frequent serious adverse reactions reported in >1% of patients who received Opdivo Qvantig were pleural effusion (1.6%), pneumonitis (1.6%), hyperglycemia (1.2%), hyperkalemia (1.2%), hemorrhage (1.2%) and diarrhea (1.2%). The most common adverse reactions (reported in ≥10% of patients) were musculoskeletal pain (31%), fatigue (20%), pruritus (16%), rash (15%), hypothyroidism (12%), diarrhea (11%), cough (11%), and abdominal pain (10%). Fatal adverse reactions occurred in 3 (1.2%) patients who received Opdivo Qvantig; these included myocarditis, myositis, and colitis complications. Study therapy was discontinued in 10% of patients due to adverse reactions.
Indications Covered
Opdivo Qvantig is approved for a wide range of solid tumor indications, including:
- Renal cell carcinoma (RCC)
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Head and neck squamous cell carcinoma (SCCHN)
- Urothelial carcinoma (UC)
- Colorectal cancer
- Hepatocellular carcinoma
- Esophageal carcinoma
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
It's important to note that Opdivo Qvantig is not indicated in combination with ipilimumab for the treatment of renal cell carcinoma, metastatic melanoma, metastatic non-small cell lung cancer and metastatic esophageal cancer.
Implications for Cancer Care
The approval of Opdivo Qvantig represents a significant step forward in patient-centered cancer care. By offering a faster, more convenient administration option, this subcutaneous formulation has the potential to improve the treatment experience for many patients while maintaining the efficacy and safety of intravenous Opdivo.
