▎WuXi AppTec Content Team Report

Bristol-Myers Squibb has just announced that the anti-PD-1 monoclonal antibody Opdivo (nivolumab injection) has been approved by the China National Medical Products Administration (NMPA).In combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinomaAccording to the press release from Bristol-Myers Squibb, after this approval, Opdivo in combination with chemotherapy has become the first and currently the only immunotherapy approved in China for the first-line treatment of advanced urothelial carcinoma. The current indications for Opdivo alsoCovering both early adjuvant treatment and late first-line treatment of urothelial carcinoma simultaneously, is expected to become a cornerstone solution for the entire treatment process of urothelial carcinoma in China.

Urothelial carcinoma is one of the most common malignant tumors of the urinary system, and its incidence rate in China has been on the rise in recent years. For patients who are already metastatic and unable to undergo surgery at the time of diagnosis, first-line treatment represents their best opportunity for efficacy. However, progress in this field has been slow for a long time. The previously recognized most effective regimen was platinum-based chemotherapy established in the 1980s, which offered limited overall benefits and resulted in shorter patient survival, leaving a significant unmet need in clinical practice.

According to the Bristol-Myers Squibb press release, this approval was based on the Phase 3 CheckMate-9011 study, which demonstrated that the efficacy of the immunotherapy combination for first-line treatment of urothelial carcinoma was significantly superior to standard cisplatin chemotherapy, with improved overall survival (OS）Significant benefits were achieved in both overall survival (OS) and progression-free survival (PFS).

The primary endpoint results of CheckMate-901 showed that, at a median follow-up of approximately 33 months, patients who received Opdivo in combination with cisplatin-based chemotherapy, followed by sequential Opdivo monotherapy,Median OS was 21.7 months (18.9 months in the chemotherapy group), significantly reducing the risk of death by 22%.; The median PFS was 7.9 months (7.6 months in the chemotherapy group), significantly reducing the risk of disease progression or death by 28%.

In terms of treatment response, Opdivo combined with chemotherapy also demonstrated clinically meaningful improvement: the objective response rate (ORR) reached 57.6% (Chemotherapy group 43.1%)；21.7% of patients achieved complete tumor disappearance (complete response, CR), nearly twice the proportion of the chemotherapy group (11.8%).; and the median duration of CR was 37.1 months, nearly three times that of the chemotherapy group (13.2 months). In the study, the combination of Opdivo and chemotherapy was well tolerated, with a safety profile consistent with previous data over a treatment period of up to two years, and no new safety signals were identified.

Not only that, but in post-hoc analyses of studies based on smaller patient numbers, Opdivo combined with chemotherapyFor lymph node-only metastasis (i.e., the disease has not metastasized to sites or organs other than lymph nodes),Official) patientsShowed encouraging efficacy:The median OS of patients was close to 4 years (46.3 months)., reducing the risk of death by 42%;Median PFS reached 30.5 months, reducing62% risk of disease progression or death;More than 80% of patients experienced significant tumor shrinkage (ORR: 81.5%), and over 60% of patients achieved complete tumor disappearance (CR rate: 64.3%).。

Opdivo was approved in July 2014 as the world's first PD-1 inhibitor and has now been approved for 12 types of cancer across more than 65 countries and regions, covering lung cancer, head and neck cancer, gastric cancer, esophageal cancer, liver cancer, renal cancer, colorectal cancer, urothelial carcinoma, melanoma, Hodgkin's lymphoma, pleural tumors, and cancers of unknown primary origin. In China, immunotherapy based on Opdivo has currently been approved for 11 indications.

[1] China’s First! Opdivo® Combined with Cisplatin-Based Chemotherapy Approved for First-Line Treatment of Urothelial Carcinoma. Retrieved Nov 5, 2024, from https://mp.weixin.qq.com/s/8at1jm_7Aj7E3gFtpjsmJg