FDA Approves Subcutaneous Form of Bristol Myers Squibb's Opdivo Qvantig for Multiple Solid Tumor Indications

Image Credit: Adobe Stock Images/Murda

The FDA has approved Bristol Myers Squibb’s (BMS) Opvido Qvantig (nivolumab and hyaluronidase-nvhy) for subcutaneous (SC) administration in most adult solid tumor indications previously approved for Opdivo (nivolumab). According to the company, the new formulation combines Opdivo with recombinant human hyaluronidase (rHuPH20), which demonstrated non-inferior pharmacokinetics, similar efficacy in overall response rate (ORR), and a comparable safety profile to intravenous (IV) Opdivo in the Phase III CheckMate-67T trial.¹

“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,” said Saby George, MD, FACP, medical oncologist, director of network clinical trials at Roswell Park Comprehensive Cancer Center, in a press release. “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.”

The Phase III, randomized, open-label, noninferiority CheckMate-67T trial compared Opdivo Qvantig to IV Opdivo, in adult patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who received prior systemic therapy. As part of the trial, patients were randomly assigned to receive either SC Opdivo Qvantig (1,200 mg of nivolumab and 20,000 units of hyaluronidase) every four weeks (n = 248), or IV Opdivo 3 mg/kg every two weeks (n = 247). The dual primary endpoints of the study were time-averaged concentration over 28 days and minimum concentration at steady state, while the secondary endpoint was ORR as assessed by blinded independent central review.

Results found comparable ORR outcomes, with Opdivo Qvantig demonstrating 24% compared to 18% for Opvido. Further, noninferiority was demonstrated for the co-primary endpoints of time-averaged concentration over 28 daysand minimum concentration at steady state, meeting the primary endpoint.

BMS warns that both treatments can result in a number of adverse events (AEs), including pneumonitis; colitis; hepatitis and hepatotoxicity; endocrinopathies; nephritis with renal dysfunction; dermatologic AEs; other immune-mediated AEs; complications of allogeneic hematopoietic stem cell transplantation; embryo-fetal toxicity; and increased mortality in patients with multiple myeloma.¹

“At Bristol Myers Squibb, we are committed to helping patients in all aspects of their healthcare journey,” said Adam Lenkowsky, EVP, chief commercialization officer, BMS, in the press release. “Over the last decade, Opdivo has evolved as an immunotherapy option used in many indications across tumor types. With this new option, we look forward to further helping cancer patients with an administration method that gives them faster delivery.”

According to Cleveland Clinic, RCC accounts for approximately nine out of 10 kidney cancer diagnoses, making it the most common form. In turn, eight out of 10 RCC diagnoses are ccRCC, with approximately 76,000 people in the United States receiving a diagnosis annually. While it can affect all ages, races and genders, it is twice as common in men compared to women. Additionally, it most commonly occurs between 50 and 70 years of age, with only 6% of cases found in children or young adults.²

“Receiving a cancer diagnosis can be frightening and stressful,” said Audrey Davis, LPC, senior director, programs and health equity, Cancer Support Community, in the press release. “Having a treatment option that may offer patients flexibility to receive treatment outside of traditional hospital settings and reduce the administration time is important. It’s exciting to see these continued advancements with immunotherapy administration that may offer another choice for patients and caregivers navigating this difficult journey.”

References

1. U.S. Food and Drug Administration Approves Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy) Injection, for Subcutaneous Use in Most Previously Approved Adult, Solid Tumor Opdivo® (nivolumab) Indications. BMS. December 27, 2024. Accessed January 2, 2025. https://news.bms.com/news/corporate-financial/2024/US-Food-and-Drug-Administration-Approves-Opdivo-Qvantig-nivolumab-and-hyaluronidase-nvhy-Injection-for-Subcutaneous-Use-in-Most-Previously-Approved-Adult-Solid-Tumor-Opdivo-nivolumab-Indications12/default.aspx

2. Clear Cell Renal Cell Carcinoma. Cleveland Clinic. Accessed January 2, 2025. https://my.clevelandclinic.org/health/diseases/22273-clear-cell-renal-cell-carcinoma