US-based pharmaceutical giant Bristol-Myers Squibb (BMS, NYSE: BMY) has secured another indication approval in China for its PD-1 inhibitor Opdivo (nivolumab). The immunotherapy is now approved for use in combination with chemotherapy as neoadjuvant therapy for adult patients with resectable non-small cell lung cancer (NSCLC), regardless of PD-L1 expression levels. This marks the first approval of an immunotherapy regimen for the neoadjuvant treatment of NSCLC in China.
Approval Backed by CheckMate-816 Study Results
The regulatory approval is based on the positive outcomes of the global Phase III CheckMate-816 study, which evaluated the efficacy and safety of nivolumab combined with chemotherapy as a neoadjuvant therapy for operable NSCLC. The study compared the combination therapy to chemotherapy alone, with results showing a pathological complete response (pCR) rate of 24% in the nivolumab/chemotherapy group, nearly 11 times higher than the 2.2% observed in the chemotherapy-only group. Additionally, the combination therapy significantly prolonged the median event-free survival (EFS) to 31.6 months compared to 20.8 months in the chemotherapy group, reducing the risk of disease progression, recurrence, or death by 37%. Subgroup analysis indicated that patients across different pathological types, PD-L1 expression levels, and disease stages could benefit from the combination therapy.
Opdivo’s Global and Chinese Approvals
Opdivo, the world’s first PD-1/L1 inhibitor, has been approved for a wide range of cancer indications, including lung, head and neck, stomach, esophageal, liver, kidney, colorectal, and urothelial cancers, as well as melanoma, Hodgkin’s lymphoma, pleural tumors, and tumors of unknown primary origin. The drug has received regulatory approvals in 66 countries worldwide. In China, Opdivo became the first PD-1/L1 inhibitor to be approved and has since secured eight indication approvals, further cementing its position as a cornerstone of cancer immunotherapy.-Fineline Info & Tech
