Bristol-Myers Squibb announced the China National Drug Administration (CNDA) has approved Opdivo (nivolumab injection) for 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 tumor aberrations. This is China’s first and only PD-1 inhibitor and is the only Immuno-Oncology (I-O) agent to demonstrate a survival benefit compared with chemotherapy, based on data from the pivotal Phase 3 CheckMate -078 trial, in which 90% of the patients enrolled were Chinese.
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“Lung cancer is a major public health issue in China, representing the highest incidence and mortality among all cancers in the country,” said Professor Yi-Long Wu, a tenured director 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.”
The approval is based on results from the Phase 3 CheckMate -078 trial of Opdivo versus chemotherapy among patients with previously treated NSCLC, findings from which were presented at the American Association for Cancer Research Annual Meeting in April 2018. In November 2017, the trial was stopped early because the independent Data Monitoring Committee concluded that Opdivo demonstrated superior overall survival compared with chemotherapy. The application later received priority review by the Center for Drug Evaluation in China.
In CheckMate -078, Opdivo reduced the risk of death by 32% versus chemotherapy, the primary endpoint (HR 0.68; 97.7% CI: 0.52 to 0.90; p=0.0006), in patients with previously treated NSCLC. Both efficacy and safety of Opdivo in this patient population were consistent with the results of the landmark global CheckMate -017 and -057 studies. In CheckMate -078, Grade 3-4 treatment-related adverse events (TRAEs) occurred less frequently with Opdivo versus docetaxel (10% vs. 48%). Discontinuations due to Grade 3-4 TRAEs were also less frequent with Opdivo (3%) than with docetaxel (5%).