Bristol Myers Squibb's PD-1 Inhibitor Opdivo Approved in China for New Perioperative Indication in Resectable Non-Small Cell Lung Cancer

Today (April 22), Bristol-Myers Squibb has just announced that the PD-1 inhibitor Opdivo (nivolumab injection) has received approval from China's NMPA for a new indication:In combination with platinum-based chemotherapy as neoadjuvant therapy, followed by Opdivo (Nivolumab) as a single-agent adjuvant treatment post-surgery, for the treatment of resectable Stage II, IIIA andStage IIIB with no known epidermal growth factor receptor (EGFR) Mutation or Anaplastic Lymphoma Kinase(ALK) Re-arranged adult non-small cell lung cancer (NSCLC) patients。

The press release stated that the approval was based on the CheckMate-77T study, which is another trial confirming after CheckMate-816.Phase 3 Study Shows Nivolumab Regimen Brings Significant Benefits for Resectable Non-Small Cell Lung Cancer. This approval also means that,Nivolumab becomesApproved for Two Indications of Resectable NSCLC in ChinaImmunotherapy drugs,Covering the perioperative period and单纯新辅助治疗, have receivedPatients treated with neoadjuvant nivolumab and surgical resection have more subsequent treatment options available.

CheckMate-77T is a global Phase 3 randomized controlled study designed to evaluateNivolumab Combined with Platinum Doublet Chemotherapy, Sequential Surgery andEfficacy of Nivolumab Monotherapy as Adjuvant Treatment Compared to Neoadjuvant Chemotherapy Plus Placebo, Sequential Surgery, and Placebo Adjuvant Treatment in Patients with Resectable Non-Small Cell Lung Cancer.

The main endpoint results of the study showed,Comparison of Perioperative Chemotherapy and Placebo Groups,Nivolumab group significantly reduced the risk of disease recurrence, progression, or death by 42%.。Secondary endpoints,25.3% of patients in the Nivolumab regimen group achieved pathological complete response (pCR, meaning no viable tumor cells were found in the surgically removed primary tumor and lymph node specimens), compared to 4.7% in the chemotherapy group.. In the study,The safety of the nivolumab regimen is controllable, and no new adverse reaction signals have been found.

In addition, subgroup analysis for Chinese patients showed that,Nivolumab regimen demonstrates consistent benefits and safety in Chinese patients,Can reduce the risk of disease recurrence, progression, or death by 60%, pCR rate was 35.1% (3.2% in the chemotherapy group).

After this approval,Nivolumab has been approved for 13 indications in China, including four early-stage tumor indications, such as perioperative, neoadjuvant, and adjuvant treatments, covering lung cancer, esophageal cancer, and urothelial carcinoma.

References:

[1]Perioperative and Neoadjuvant Full Coverage! Opdivo® Adds New Indication for Resectable Lung Cancer.Retrieved Apr 22，2025, From  https://mp.weixin.qq.com/s/q-6HXzqaI3zVnT5Mop_pvA