US-based Bristol-Myers Squibb (BMS, NYSE: BMY) has secured another new indication approval in China for its programmed death-1 (PD-1) inhibitor Opdivo (nivolumab). The immunotherapy is now approved for use as a neoadjuvant therapy for patients with urothelial carcinoma (UC) at high risk of recurrence after radical resection. This marks the first PD-1 inhibitor to receive approval for neoadjuvant therapy in UC in China, making Opdivo the only PD-1/L1 inhibitor with two neoadjuvant therapy indications in the country.
Approval Based on CheckMate-274 Study
The approval is based on the CheckMate-274 study, a randomized, double-blind, multi-center global Phase III trial enrolling 709 patients, including those from mainland China. The study demonstrated that Opdivo significantly reduced the risk of disease recurrence in patients with myo-invasive urothelial carcinoma (MIUC). The latest follow-up data showed that the median disease-free survival (DFS) in the Opdivo group was 22.0 months, compared to 10.9 months in the placebo control group, representing a 30% reduction in the risk of disease recurrence or death.
Clinical Need and Guidelines Inclusion
Bladder cancer incidence has been rising in China, with 85,700 new cases and 39,400 deaths reported in 2020. Myo-invasive bladder urothelial cancer is characterized by low pathological staging, high malignancy, and poor prognosis, with over 50% of patients relapsing after radical resection. Historically, there has been a lack of high-level evidence to support adjuvant therapy recommendations for these patients, and some are not suitable for existing adjuvant chemotherapy, leaving significant unmet treatment needs. Based on the CheckMate-274 results, Opdivo has been included in the Chinese Society of Clinical Oncology (CSCO) guidelines for the diagnosis and treatment of urinary epithelial cancer and the National Comprehensive Cancer Network (NCCN) bladder cancer clinical practice guidelines, becoming the only recommended adjuvant immunotherapy drug for urothelial cancer.-Fineline Info & Tech
