Bristol Myers Squibb’s Subcutaneous PD-1 Inhibitor Opdivo Achieves Phase 3 Primary Endpoints with Administration Time Under 5 Minutes

▎WuXi

Edited by Kant Content Team

Bristol-Myers Squibb today announced that itsOpdivo (nivolumab) Subcutaneous Injection Formulation Meets Primary Endpoint in Phase 3 Clinical Trial CheckMate-67TCompared with intravenous infusion of Opdivo, subcutaneous injection of Opdivo demonstrated non-inferiority in terms of average serum concentration over 28 days (Cavgd28) and steady-state serum trough concentration (Cminss).In addition, as assessed by blinded independent central review (BICR), compared with intravenous infusion of Opdivo, the subcutaneous injection formulation...Showed non-inferiority in objective response rate (ORR), this is a key secondary endpoint.

Opdivo is a PD-1 immune checkpoint inhibitor designed to harness the body's own immune system to help restore anti-tumor immune responses.Opdivo has become an important treatment option across multiple types of cancer. To date, the Opdivo clinical development program has treated more than 35,000 patients. CheckMate-67T is a randomized, open-label Phase 3 clinical trial evaluating a subcutaneous formulation of Opdivo, formulated with Halozyme's proprietary recombinant human hyaluronidase rHuPH20, compared to intravenous infusion of Opdivo, in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have previously received systemic therapy. The press release stated,Opdivo Subcutaneous Formulation Can Be Administered in a Single Injection Within 5 Minutes, Poised to Transform the Treatment Experience for Patients and Doctors.

Bristol-Myers Squibb will complete a comprehensive evaluation of the existing CheckMate-67T trial data and collaborate with investigators to present the results at an upcoming medical conference. The company also looks forward to discussing the next steps for the subcutaneous formulation of Opdivo in treating multiple indications with regulatory authorities.

References:

[1] Phase 3 CheckMate -67T Trial of Subcutaneous Nivolumab (nivolumab and hyaluronidase) Meets Co-Primary Endpoints in Advanced or Metastatic Clear Cell Renal Cell Carcinoma. Retrieved October 19, 2023, from https://www.businesswire.com/news/home/20231018115252/en