Bristol Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has granted approval for Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy) Injection for subcutaneous use. This innovative combination product includes nivolumab, an immunotherapy agent, co-formulated with recombinant human hyaluronidase (rHuPH20).
The approval covers several previously approved adult solid tumor indications for Opdivo, including use as a monotherapy, monotherapy maintenance following Opdivo plus Yervoy® (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.
The approval was based on the promising results of the Phase 3 CheckMate-67T trial, a randomized, open-label study. The Injection trial demonstrated that Opdivo Qvantig has non-inferior pharmacokinetic (PK) exposure compared to intravenous (IV) Opdivo, showing similar efficacy in terms of overall response rate (ORR) and a comparable safety profile. According to Professor Dr. Saby George, MD, FACP, a medical oncologist and director of network clinical trials at Roswell Park Comprehensive Cancer Center.
“This approval of Injection subcutaneous nivolumab provides patients with a new option that delivers the same efficacy and safety we expect from IV nivolumab, while offering a more patient-centric treatment experience. Opdivo Qvantig allows for faster administration in just three to five minutes, offering patients the opportunity to receive treatment closer to home and with more flexibility in consultation with their doctors.”
FDA Approval for Opdivo Qvantig Injection
The CheckMate-67T trial showed that non-inferiority was achieved for the co-primary endpoints of time-averaged concentration over 28 days (Cavgd28) and minimum concentration at steady state (Cminss) between Opdivo Qvantig and IV Opdivo.
The geometric mean ratio (GMR) for Cavgd28 was 2.10 (90% CI: 2.00-2.20), and for Cminss, the GMR was 1.77 (90% CI: 1.63-1.93). In terms of efficacy, the overall response rate (ORR) in the Opdivo Qvantig group (n=248) was 24% (95% CI: 19-30), compared to 18% (95% CI: 14-24) for the IV Opdivo group (n=247). These results confirm that Opdivo Qvantig delivers similar efficacy to the intravenous formulation.
A key advantage of Opdivo Qvantig is the flexibility it offers in terms of treatment administration. Injection Subcutaneous administration reduces preparation steps and time required for delivery. In the trial, the average administration time for Opdivo Qvantig was about five minutes, with most patients receiving all doses without any interruptions or delays. This is a significant improvement compared to the 30-minute administration time required for IV Opdivo. With this approval, Opdivo Qvantig becomes the first and only subcutaneously administered PD-1 inhibitor, providing patients with a faster and more convenient immunotherapy option.
The approval of Opdivo Qvantig comes with important safety considerations. Both Opdivo and Opdivo Qvantig carry warnings for severe and potentially fatal immune-mediated adverse reactions, such as Injection pneumonitis, colitis, hepatitis, hepatotoxicity, endocrinopathies, nephritis with renal dysfunction, dermatologic reactions, and other immune-mediated adverse effects.
Additionally, patients receiving these Injection treatments should be aware of the risks associated with complications following allogeneic hematopoietic stem cell transplantation (HSCT), embryo-fetal toxicity, and an increased risk of mortality in multiple myeloma patients when used in combination with thalidomide analogues and dexamethasone. Infusion-related reactions may also occur with IV Opdivo.
Adam Lenkowsky, Executive Vice President and Chief Commercialization Officer at Bristol Myers Squibb, emphasized the company’s commitment to improving patient care, stating, “We are dedicated to helping patients throughout their healthcare journey. Over the past decade, Opdivo has become a critical immunotherapy option across multiple tumor types and indications. This new approval provides an even faster delivery option, which we believe will offer great benefits for cancer patients.”
Audrey Davis, LPC and Senior Director of Programs and Health Equity at the Cancer Support Community, added, “A cancer diagnosis can be overwhelming for patients and their families. Having treatment options that offer more flexibility, including the ability to receive therapy outside of traditional hospital settings and with reduced administration time, is incredibly important. It’s inspiring to see these advancements in immunotherapy administration that offer another choice for patients and caregivers during this difficult journey.”
With this approval, Opdivo Qvantig provides an innovative solution Injection for patients who require immunotherapy but prefer a more convenient and faster treatment option. This development aligns with Bristol Myers Squibb’s ongoing commitment to improving the treatment experience for cancer patients while maintaining the proven efficacy and safety of the IV formulation. As more patients explore this new option, it may significantly impact the way immunotherapy is delivered and offer a more flexible treatment approach for a variety of cancer types.
