BMS Reports P-III Trial (CheckMate -67T) Results of Nivolumab (nivolumab and hyaluronidase) for Advanced or Metastatic Clear Cell Renal Cell Carcinoma
Shots:
- The P-III trial evaluating Opdivo (SC) co-formulated with Halozyme’s recombinant human hyaluronidase, rHuPH20, or nivolumab (SC) vs Opdivo (IV) in 495 patients with advanced or metastatic ccRCC who have received prior systemic therapy
- The trial met its co-primary pharmacokinetics EPs & 2EPs which demonstrated noninferiority of Cavgd28 (time-averaged Opdivo serum concentration over 28 days) and Cminss (trough serum concentration at steady state). Nivolumab also showed a non-inferior ORR
- The safety profile of nivolumab (SC) was consistent with the IV formulation. The company seeks to discuss the next steps for submission and approval of nivolumab (SC) with health authorities across multiple indications
Ref: BMS | Image: BMS
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