China's First! Nivolumab Approved for First-Line Treatment of Unresectable or Metastatic Urothelial Carcinoma in Combination with Cisplatin and Gemcitabine

On November 5, Bristol-Myers Squibb announced that NivolumabMonoclonal antibody approved by NMPA,In combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma。

Screenshot source: BMS Official WeChat

Following this approval, Opdivo in combination with chemotherapy has becomeThe First and Only Approved in ChinaImmunotherapy for first-line treatment of advanced urothelial carcinoma, Opdivo has also become currentlyThe only indication that simultaneously covers early adjuvant treatment and late first-line treatment for urothelial carcinoma.The PD-1 inhibitor is expected to become the cornerstone solution for the entire treatment process of urothelial cancer in China.

This approval is based onIII Phase Study CheckMate-9011, this isThe world's first confirmedImmunotherapy Combination Shows Significantly Superior Efficacy to Standard Cisplatin Chemotherapy as First-Line Treatment for Urothelial CarcinomaIII Phase clinical study, and the overall survival of patients(OS) Progression-Free Survival(PFS)Significant benefits were achieved.

CheckMate-901 Primary Endpoint Results Show That InAt approximately 33 months of follow-up, the patient received Opdivo in combination with cisplatin-based chemotherapy, followed by sequential Opdivo monotherapy.Median Overall Survival (OS)21.7 months (18.9 months in the chemotherapy group), significantly reducing the risk of death by 22%.(HR0.78，p=0.0171); Median Progression-Free Survival(PFS)At 7.9 months (7.6 months in the chemotherapy group), significantly reducing the risk of disease progression or death by 28%. (HR0.72，p=0.0012)。

In terms of treatment response, Opdivo combined with chemotherapy also demonstrated clinically meaningful improvement: Objective Response Rate (ORR) reached 57.6% (43.1% in the chemotherapy group); tumors completely disappeared in 21.7% of patients.(Complete Remission, CR), nearly twice the proportion of the chemotherapy group (11.8%); and the median CR duration can reach 37.1 months, nearly three times that of the chemotherapy group (13.2 months).

In the study, Opdivo (nivolumab) combined with chemotherapy was well tolerated. During the treatment cycle of up to 2 years, the safety profile was consistent with previous data, and no new safety signals were identified.

Not only that, but also in the post-hoc analysis of studies based on a smaller patient populationIn the analysis, Opdivo combined with chemotherapy for lymph node-only metastasis(i.e., the disease has not metastasized to sites or organs other than lymph nodes)Patients showed encouraging efficacy: the median OS was nearly 4 years (46.3 months), reducing the risk of death by 42% (HR 0.58); the median PFS reached 30.5 months, reducing the risk of disease progression or death by 62% (HR 0.38); over 80% of patients had significant tumor shrinkage (ORR: 81.5%), and more than 60% of patients had complete tumor disappearance (CR rate: 64.3%).

Opdivo is currently the only immunotherapy drug in China that covers both early and late-stage treatment of urothelial carcinoma. It is expected to serve as the cornerstone solution for the full-course treatment of urothelial carcinoma in China, bringing the hope of longer survival to more patients.

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Disclaimer:This article is for information sharing only,不代表 Insight 立场和观点, and does not recommend or introduce any treatment options. If needed, please consult and contact正规医疗机构.

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