Bristol-Myers Squibb (BMS; NYSE: BMY) has announced positive results from a Phase III comparative study of its anti-PD-1 drug Opdivo (nivolumab) formulated as a subcutaneous injection. The study, conducted in pre-treated advanced or metastatic clear cell renal cell carcinoma (ccRCC) patients, utilized Halozyme Therapeutics’ (NASDAQ: HALO) proprietary hyaluronidase (rHuPH20) for the formulation.
Study Outcomes and Opdivo’s Efficacy
The patient-friendly subcutaneous form of Opdivo demonstrated non-inferiority to the original intravenous version in terms of time-averaged and minimum serum concentration, as well as objective response rate (ORR). These results highlight the potential of the subcutaneous formulation to offer similar efficacy with the convenience of a less invasive administration method.
Future Regulatory Filings and Study Continuation
BMS plans to leverage these data to support regulatory filings for multiple indications of the subcutaneous Opdivo. The company will also continue the study to assess additional efficacy and safety endpoints, further validating the benefits of this innovative formulation.-Fineline Info & Tech
