Monday, July 15, 2024

Renal Cell Carcinoma Treatment Advances: EMA Validates New Subcutaneous Opdivo® Formulation

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The European Medicines Agency (EMA) has validated Bristol Myers Squibb’s extension application for a new subcutaneous formulation of Opdivo® (nivolumab) for renal cell carcinoma. This validation is based on results from the Phase 3 CheckMate -67T trial, which demonstrated non-inferior pharmacokinetics and efficacy compared to the intravenous formulation. The application seeks approval to treat multiple adult solid tumor indications.

The CheckMate -67T trial showed that subcutaneous nivolumab is as effective as its intravenous counterpart. Patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who had received no more than two prior lines of systemic therapy were included. The study’s primary endpoints, Cavgd28 (time-averaged Opdivo serum concentration over 28 days) and Cminss (trough serum concentration at steady state) confirmed non-inferiority. Additionally, the subcutaneous form demonstrated a comparable objective response rate (ORR) and maintained a consistent safety profile.

Susan Parker, VP, Global Program Lead, Product Design & Development at Bristol Myers Squibb, commented, “Subcutaneous nivolumab could significantly reduce administration time, providing the same quality of care as IV Opdivo in a fraction of the time. We are committed to improving the patient experience by offering innovative formulations across our portfolio.”

The Trial Showcases Subcutaneous Opdivo as Promising Renal Cell Carcinoma Treatment Option

In the CheckMate -67T trial, 495 patients were randomized to receive either subcutaneous nivolumab or intravenous Opdivo. The trial confirmed the noninferiority of subcutaneous nivolumab in terms of pharmacokinetics and efficacy. The results were presented at the 2024 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium, highlighting its potential to simplify treatment for patients with multiple types of solid tumors.

The safety and efficacy results from CheckMate -67T were promising, showing that subcutaneous nivolumab could offer a new, more convenient treatment option for cancer patients. The streamlined administration process could enhance patient comfort and compliance, ultimately improving treatment outcomes.

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor designed to harness the body’s immune system to combat renal cell carcinoma. It is a crucial treatment option for multiple cancers and has been approved in over 65 countries, including the U.S., EU, Japan, and China. Opdivo’s global development program includes numerous clinical trials across all phases and a variety of tumor types, treating over 35,000 patients to date.

Renal Cell Carcinoma

Bristol Myers Squibb Advances Renal Cell Carcinoma Care

Bristol Myers Squibb is dedicated to transforming patients’ lives through scientific advancements. The company’s research in cancer aims to deliver innovative treatments that improve survival rates and quality of life for patients. By exploring new frontiers in personalized medicine and leveraging digital platforms for data insights, Bristol Myers Squibb continues to push the boundaries of renal cell carcinoma care.

The company’s broad range of clinical trials and a deep understanding of human biology uniquely position Bristol Myers Squibb to approach cancer from multiple angles. They aim to provide comprehensive care, from diagnosis to survivorship and are committed to making significant strides in the fight against cancer.

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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). The trial included 495 patients with advanced or metastatic renal cell carcinoma who had prior systemic therapy. The primary endpoints were the time-averaged serum concentration over 28 days and trough serum concentration at steady state. The trial’s success supports the potential of subcutaneous Opdivo to offer an easier and quicker treatment alternative.


Resource: Bristol Myers Squibb, June 21, 2024

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