BMS' Opdivo becomes first immuno-oncology agent available in China

Bristol-Myers Squibb’s flagship immunotherapy Opdivo (nivolumab) has broken ground to become the first and only PD-1 inhibitor to be made available in China. The drug was approved by the new China National Drug Administration in the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior platinum-based chemotherapy in adult patients without EGFR or ALK genomic tumour aberrations.

The decision was based on Phase 3 data from the CheckMate -078 trial, a study which was halted early at the recommendation of an independent Data Monitoring Committee. The data demonstrated that Opdivo reduced the risk of death by 32% compared to chemotherapy in patients with previously treated NSCLC, making it the only drug available in the China to do so. Additionally, median overall survival (OS) stood at 12 months compared to 9.6 months with chemotherapy, and Opdivo also improved OS versus docetaxel in patients with squamous and non-squamous tumour histology and across all pre-defined subgroups based on tumour PD-L1 expression level.

"Lung cancer is a major public health issue in China, representing the highest incidence and mortality among all cancers in the country," commented Professor Yi-Long Wu of Guangdong General Hospital and the chair of the Chinese Thoracic Oncology Group. "With most lung cancer patients already at an advanced stage when diagnosed, prolonging survival is an important goal. The approval of Opdivo as the first I-O agent in China is a significant therapeutic advance and is great news for patients and clinicians alike, offering for the first time an I-O treatment option that is proven to extend survival in predominantly Chinese patients with previously treated NSCLC."

Dr Fouad Namouni, Head of Development, Oncology at Bristol-Myers Squibb, also remarked: "We are thrilled to be able to bring this proven treatment, Opdivo, which has demonstrated superior overall survival versus chemotherapy in previously treated NSCLC patients in China, and are committed to working with stakeholders to ensure patients can quickly access Opdivo. With more than 7,500 cancer deaths per day estimated in China, we will continue to work with urgency to integrate the unmet treatment needs of Chinese patients in our ongoing I-O global development programme, with the goal of bringing them innovative therapies as quickly as possible."