China's First! BMS PD-1-Based Dual Immunotherapy Receives NMPA Approval for Newly Approved Indication

On July 28, Bristol-Myers Squibb announced Opdivo(Nivolumab Injection)In combination with Yiyiwo(Ipilimumab Injection)The solution has been approved by China NMPA and is applicable to PD-L1 tumor proportion score. (TPS) ≥1%First-line Treatment for Metastatic Non-Small Cell Lung Cancer with EGFR Mutation-Negative and ALK-Negative, becomingChina's First Approved Lung Cancer Dual Immunotherapy Combination。

This approval is based on the CheckMate-227 study, the world's first Phase III clinical trial of a dual immunotherapy regimen for the first-line treatment of non-small cell lung cancer, which evaluated the efficacy of Opdivo in combination with Yervoy versus chemotherapy. It is also one of the Phase III studies with the longest follow-up time in the field of non-small cell lung cancer immunotherapy to date. Data confirms that this regimen provides long-term, sustained survival benefits.Achieved 6-Year Long-Term Survival in 22% of Patients with PD-L1≥1%(Chemotherapy group 13%), while avoiding chemotherapy toxicity, offering a new option for high-quality long-term survival for this patient population.

• The primary endpoint results of the study showed that in patients with PD-L1≥1%, Opdivo combined with YervoySignificantly improve median overall survival (mOS) Up to 17.1 months, chemotherapy group was 14.9 months, hazard ratio [HR]=0.79, P=0.007.

• Opdivo + Yervoy GroupMedian Duration of Response (mDoR) Over 2 years, reaching 24.5 months，(Only 6.7 months for the chemotherapy group), and 66% of the 5-year survival patients did not receive subsequent systemic treatment.(Only 20% in the chemotherapy group), indicating that this regimen can provide long-term stable survival benefits.

• In terms of safety, the study showed that the safety of Opdivo (Nivolumab) combined with Yervoy (Ipilimumab) is controllable and manageable: any grade and 3-4 grade treatment-related adverse events.(TRAE)The incidence rates were 77% and 33%, respectively, while in the chemotherapy group, they were 82% and 36%, respectively.

Exploratory analysis of the study further showed that in populations with mutations such as KEAP1, STK11, or TP53, who previously benefited less from immunotherapy combined with chemotherapy, Opdivo (Nivolumab) combined with Yervoy (Ipilimumab) reduced the risk of death by 69%, 22%, and 28% respectively compared to chemotherapy alone. This suggests consistent benefits of this regimen for the aforementioned populations.

Moreover, in the Chinese bridging trial CheckMate-227 CHESS of the study, a consistent benefit trend was observed in the Chinese population as with the global population.

Currently, the Opdivo plus Yervoy regimen has been approved for use in China.Pleural Mesothelioma, Colorectal Cancer, Hepatocellular Carcinoma, Lung CancerAnd multiple other types of cancer.

Scan the WeChat QR code, add the editor of the Antibody Circle, and those who meet the requirements can join the Antibody Circle WeChat group!

Please indicate: Name + Research Direction!

All reproduced articles in this official account are intended to convey more information, with the source and author clearly indicated. Media or individuals who do not wish to be reproduced can contact us (cbplib@163.com), and we will immediately delete the content. All articles represent the views of the author and do not represent the position of this site.