BMS Announces Positive Phase III Results for Subcutaneous Nivolumab in Previously Treated Advanced Clear Cell Renal Cell Carcinoma

Oct 20, 2023 08:07 CST Updated 08:07

Bristol-Myers Squibb

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On October 19, Bristol-Myers Squibb (BMS) announcedSubcutaneous Injection Formulation of Nivolumab (Opdivo) Compared with Its Intravenous Formulation for Advanced or Metastatic Patients Previously Treated with Systemic TherapyPatients with clear cell renal cell carcinoma (ccRCC) IPhase II CheckMate-67T Study Met Co-Primary and Key Secondary Endpoints.

NivolumabUstekinumab Subcutaneous Injection Formulation byNivolumabUstekinumab andHalozyme's proprietary recombinant human hyaluronidase PH20 (rHuPH20).

CheckMate-67T is a randomized, open-label Phase III clinical trial, totaling495 patients were randomly assigned to receiveNivolumabYoodanAnti-Subcutaneous or intravenous formulations, the primary endpoint is the time-averaged serum concentration on Day 28 (Cavgd28) andAt steady stateValley serum concentration (Cminss), key secondary endpoint wasObjective Response Rate (ORR).

The study results showed that, compared with the intravenous formulation, the subcutaneous formulation of nivolumab demonstrated non-inferior pharmacokinetic characteristics.GuestObservation of Remission Rate。BMS stated, will comprehensively evaluate the entire study data as soon as possible and announce the specific results at the upcoming medical conference.

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