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Positive Topline Results Reported from Bristol Myers Squibb's Phase 3 CheckMate-67T Trial of Subcutaneous Nivolumab with Halozyme's ENHANZE® Drug Delivery Technology for Advanced or Metastatic Clear Cell Renal Cell Carcinoma
BMS in discussions with health authorities regarding next steps for submission and approval of subcutaneous nivolumab in multiple indications SAN DIEGO, Oct.
About this update from Halozyme Therapeutics, Inc.
[{"type":"text","content":"BMS in discussions with health authorities regarding next steps for submission and approval of subcutaneous nivolumab in multiple indications\nSAN DIEGO, Oct. 19, 2023 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (\"Halozyme\") today announced that Bristol Myers Squibb (BMS) reported positive topline results from the Phase 3 CheckMate-67T trial evaluating a subcutaneous (SC) formulation of Opdivo (nivolumab) with ENHANZE® in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy. The study met its co-primary pharmacokinetics endpoints and key secondary endpoint.\nCheckMate-67T Data Highlights\nCo-primary endpoints met; the study demonstrated noninferiority of Cavgd28 (time-averaged Opdivo serum concentration over 28 days) and Cminss (trough serum concentration at steady state) compared to intravenous (IV) Opdivo.Subcutaneous nivolumab showed noninferiority of objective response rate (ORR) by Blinded Independent Central Review (BICR) vs. IV Opdivo, a key secondary endpoint.The safety profile of SC nivolumab was consistent with IV Opdivo.\"We are pleased that the positive topline results from BMS' trial of subcutaneous nivolumab with ENHANZE support a shorter treatment time, as a single injection administered in less than five minutes, potentially making it a more convenient treatment option for patients,\" said Dr. Helen Torley, president and chief executive officer of Halozyme. \"This is the fifth positive phase 3 data readout from our Wave 3 products in the last 19 months, supporting the high success rate in the translation of phase 1/2 ENHANZE SC pharmacokinetic data into positive phase 3 data.\" \nBMS will share detailed results from the CheckMate-67T trial at an upcoming medical meeting and work with health authorities on next steps for SC nivolumab across multiple indications.\nAbout CheckMate-67T\nCheckMate-67T is a Phase 3 randomized, open-label trial evaluating subcutaneous administration of Opdivo co-formulated with Halozyme's proprietary recombinant human hyaluronidase rHuPH20, or subcutaneous nivolumab (nivolumab and hyaluronidase) compared to intravenous Opdivo, in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy. This trial presents an opportunity to potentially bring a su...