Subcutaneous Nivolumab Noninferior to IV Opdivo in Advanced Clear Cell Renal Cell Carcinoma: CheckMate -67T

The Phase 3 CheckMate -67T trial has revealed that the subcutaneous form of nivolumab, when combined with Halozyme’s recombinant human hyaluronidase (rHuPH20), shows noninferior pharmacokinetics and efficacy compared to the intravenous version of Opdivo. This is significant for patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have had prior systemic therapy.

The trial, which compared subcutaneous nivolumab to intravenous Opdivo, demonstrated that the subcutaneous version was noninferior in terms of time-averaged serum concentration over 28 days (Cavgd28) and the minimum serum concentration at steady state (Cminss). Additionally, the objective response rate (ORR), as assessed by a Blinded Independent Central Review (BICR), was also noninferior, with a 24.2% response rate for subcutaneous nivolumab compared to 18.2% for intravenous Opdivo.

The results, which will be presented at the ASCO 2024 Genitourinary Cancers Symposium, indicate that the subcutaneous administration of nivolumab could potentially reduce the treatment burden for cancer patients and improve healthcare efficiency. The subcutaneous injection can be administered in under five minutes and, in some cases, outside of the infusion center, which could save valuable time for both patients and healthcare providers.

Dr. Saby George, a professor of Oncology and Medicine, highlighted the potential impact of these findings, stating that the option to administer immunotherapy subcutaneously could help to maximize efficiencies within healthcare systems. The convenience of subcutaneous immunotherapy is also seen as a significant benefit, offering greater flexibility to patients and healthcare providers.

In the trial, the median progression-free survival (PFS) by BICR was 7.23 months for subcutaneous nivolumab and 5.65 months for intravenous Opdivo. The safety profile of the subcutaneous formulation was found to be consistent with that of the intravenous version, with a low incidence of local injection site reactions and a comparable rate of grade 3-4 adverse events.

Gina Fusaro, Ph.D., vice president at Bristol Myers Squibb, emphasized the company's commitment to improving the quality of life for patients through the use of immunotherapy in solid tumor oncology. The noninferiority of subcutaneous nivolumab compared to intravenous Opdivo supports the potential for a new treatment option that could enhance healthcare efficiency and reduce patient burden.

The CheckMate -67T trial is a Phase 3 randomized, open-label study that included 495 patients with advanced or metastatic ccRCC. The co-primary endpoints were the pharmacokinetic measures Cavgd28 and Cminss, with ORR as a key secondary endpoint. The trial represents a significant step towards potentially bringing a subcutaneous formulation of Opdivo to patients.

Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, with ccRCC being the most prevalent form. The five-year survival rate for those diagnosed with metastatic kidney cancer is 14%, and Bristol Myers Squibb is dedicated to creating a better future for people with cancer through transformative science and a deep understanding of human biology.

Opdivo, a PD-1 immune checkpoint inhibitor, works by harnessing the body's immune system to fight cancer. It has a leading global development program and has been approved in over 65 countries for various cancer treatments. The clinical development program for Opdivo has treated more than 35,000 patients and has contributed to a deeper understanding of biomarkers in patient care.