Bristol Myers Squibb (NYSE: BMY) has taken a significant step toward the approval of Opdivo (nivolumab) in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma in the European Union. The European Medicines Agency (EMA) has validated the company’s type II variation application for this potential groundbreaking treatment, marking the initiation of EMA’s centralized review procedure.
Urothelial carcinoma is a form of bladder cancer that accounts for approximately 90% of bladder cancer cases. The disease often presents challenges in terms of treatment, especially in advanced stages. Bristol Myers Squibb believes that Opdivo in combination with cisplatin-based chemotherapy has the potential to address this unmet medical need and improve the prognosis for patients.
This application is based on the positive results from the Phase 3 CheckMate -901 trial, which is the first Phase 3 trial to demonstrate a statistically significant and clinically meaningful survival benefit over the standard-of-care cisplatin-based chemotherapy for this patient population. Opdivo, when used in combination with cisplatin-based chemotherapy followed by Opdivo monotherapy, showed significant improvements in overall survival (OS) and progression-free survival (PFS), as assessed by Blinded Independent Central Review (BICR). Additionally, the safety profile of this regimen was tolerable and consistent with the known safety profiles of the individual components, with no new safety concerns identified.
The OS and PFS data from CheckMate -901 were presented at the European Society for Medical Oncology (ESMO) Congress 2023. Opdivo and Opdivo-based combinations have shown significant improvements in OS in Phase 3 clinical trials across multiple tumor types, including metastatic urothelial carcinoma.
The CheckMate -901 trial evaluated Opdivo in combination with cisplatin-based chemotherapy versus standard-of-care chemotherapy in patients with untreated unresectable or metastatic urothelial cancer. The primary endpoints of this study are overall survival (OS) and progression-free survival (PFS). The study is ongoing to assess Opdivo plus Yervoy versus standard-of-care chemotherapy.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor designed to harness the body’s immune system to combat cancer. It has received approvals for various cancer indications globally, demonstrating its potential across a range of tumors.
Bristol Myers Squibb’s commitment to addressing the unmet needs of cancer patients is evident in its research and development efforts. The company aims to bring innovative treatments to cancer patients, improving their chances of survival and quality of life.
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