Bristol Myers Squibb (NYSE: BMY) has announced results from its Phase 3 CheckMate -67T trial, which could revolutionize treatment for patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC). The trial evaluated the subcutaneous formulation of PD-1 immune checkpoint inhibitor Opdivo (nivolumab), co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20), referred to as “subcutaneous nivolumab,” and demonstrated promising outcomes compared to the intravenous (IV) formulation.

Subcutaneous Nivolumab: A New Chapter in Oncology

Saby George from Roswell Park Comprehensive Cancer Center, highlighted the significance of this development: “The data from CheckMate -67T with the subcutaneous formulation of nivolumab represent a groundbreaking advancement in oncology research for physicians and our patients. Having the option to administer immunotherapy subcutaneously could undoubtedly reduce the treatment burden that patients diagnosed with cancer currently face.”

Key Findings of CheckMate -67T Trial

The CheckMate -67T trial, involving 495 patients, showcased noninferiority in terms of Cavgd28 and Cminss for subcutaneous nivolumab compared to IV Opdivo. The study revealed a geometric mean ratio of 2.098 for Cavgd28 and 1.774 for Cminss. Importantly, the subcutaneous nivolumab displayed a noninferior objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) versus IV Opdivo, with an ORR of 24.2% compared to 18.2%.

Progression-Free Survival and Safety

The median progression-free survival (PFS) by BICR with subcutaneous nivolumab was 7.23 months, compared to 5.65 months with IV Opdivo. The safety profile of subcutaneous nivolumab was consistent with the IV formulation, showing a low incidence of local injection site reactions and similar rates of adverse events.

Implications for Cancer Treatment

Gina Fusaro, Vice President at Bristol Myers Squibb, expressed excitement about the potential of this treatment: “We are thrilled to present this research…demonstrating noninferiority compared to intravenous Opdivo and supporting subcutaneous nivolumab as a potential new option to improve healthcare efficiency.”

The results from the CheckMate -67T trial signify a potential paradigm shift in the treatment of renal cell carcinoma. Subcutaneous nivolumab could provide a more convenient and patient-friendly option, reducing treatment time and potentially improving quality of life for patients. This innovation represents a significant step forward in the ongoing effort to make cancer treatments more effective and less burdensome.

  Bristol-Myers Squibb, cancer, CheckMate -67T Trial, Gina Fusaro, Immunotherapy, Nivolumab, Oncology, Opdivo, renal cell carcinoma, Saby George