EMA Validates Bristol Myers Squibb’s Subcutaneous Nivolumab Application

Bristol Myers Squibb announced today that the European Medicines Agency (EMA) has validated its application to introduce a new subcutaneous administration route for Opdivo® (nivolumab). This includes a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial) for multiple previously approved adult solid tumor indications. These include use as monotherapy, maintenance monotherapy after nivolumab plus ipilimumab combination therapy, or in combination with chemotherapy or cabozantinib, based on results from the Phase 3 CheckMate -67T study. The validation confirms the submission is complete and starts the EMA’s centralized review process.

“Subcutaneous nivolumab has the potential to change how cancer patients receive Opdivo, significantly reducing administration time with a single injection in three-to-five minutes. This allows patients to focus on their lives rather than spending longer at infusion centers,” said Susan Parker, vice president at Bristol Myers Squibb. “We are committed to improving the patient experience and are evaluating innovative formulations across our portfolio. We look forward to working with the EMA to advance this application and introduce the subcutaneous option of Opdivo.”

In the Phase 3 CheckMate -67T trial, subcutaneous nivolumab demonstrated noninferiority in time-averaged Opdivo serum concentration over 28 days (Cavgd28) and trough serum concentration at steady state (Cminss), the study’s primary endpoints, compared to intravenous (IV) Opdivo in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who had received no more than two prior lines of systemic therapy. Additionally, subcutaneous nivolumab showed noninferiority in the objective response rate (ORR), a key secondary endpoint, as assessed by Blinded Independent Central Review (BICR) compared to IV Opdivo. The safety profile of subcutaneous nivolumab was consistent with the IV formulation. The pharmacokinetics, efficacy, and safety results from CheckMate -67T were presented at the 2024 ASCO Genitourinary Cancers Symposium. Additional safety analyses and patient

CheckMate -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 ccRCC who had received prior systemic therapy. A total of 495 patients were randomized to either subcutaneous nivolumab or intravenous Opdivo. The co-primary endpoints are the time-averaged serum concentration over 28 days (Cavgd28) and trough serum concentration at steady state (Cminss) of subcutaneous nivolumab compared to intravenous Opdivo. Objective response rate (ORR) is a key secondary endpoint.

Bristol Myers Squibb: Creating a Better Future for People with Cancer

Bristol Myers Squibb is driven by a vision to transform patients’ lives through science. The company aims to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy in a broad range of cancers, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and leveraging innovative digital platforms to turn data into insights. With a deep understanding of human biology, cutting-edge capabilities, and differentiated research platforms, the company approaches cancer treatment from every angle.

Bristol Myers Squibb is committed to addressing all aspects of cancer care, from diagnosis to survivorship, and works to empower all people with cancer to have a better future.

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