Opdivo China lung cancer phase III checkmate-078 study results: significant survival benefits, 32% lower risk of death than chemotherapy

Source: medicine magic cube April 13, 2018, BMS announced the results of the critical phase III checkmate-078 study focusing on Chinese NSCLC patients Compared with docetaxel, opdivo can bring significant survival benefits (OS; HR 0.68; 97.7%) CI: 0.52-0.90; P = 0.0006), and the clinical benefit was not related to the expression level of PD-L1 and the histological type of tumor Compared with chemotherapy, nivolumab reduced the risk of disease progression by 23% (HR 0.77; 95% CI 0.62, 0.95; P = 0.0147) In addition, nivolumab was also superior to docetaxel in the other two secondary end points: objective response rate (ORR) and median duration of response time (mdor) The orr of the two groups was 17% and 4%, respectively; the median response duration data of the opdivo group was not mature, and that of the docetaxel group was 5.3 months The incidence of grade 3-4 treatment-related adverse events (traes) in nivolumab group was lower than that in docetaxel group (10% vs 47%), and the proportion of patients who stopped using grade 3-4 Rae was lower than that in docetaxel group (3% vs 5%) Checkmate-078 is a multicenter, randomized phase III study comparing the efficacy and safety of nivolumab and docetaxel in patients with stage IIIB / IV non-small cell lung cancer (NSCLC) who developed disease progression after dual drug chemotherapy with platinum The research is mainly conducted in China, with research centers in Hong Kong, Russia and Singapore A total of 504 patients (451 from China, 45 from Russia and 8 from Singapore) with squamous and non squamous NSCLC were enrolled in the study, including patients whose PD-L1 expression level was less than 1% and ≥ 1% They were randomly divided into two groups to receive intravenous injection of nivolumab 3 mg / kg every 2 weeks (n = 338) or intravenous injection of docetaxel 75 every 3 weeks Mg / m2 (n = 166), treatment until disease progression or intolerable toxicity The detailed results of this study will be presented orally (Abstract No ct114) in the "latest progress in clinical research on immunotumours" session of the American Association for cancer research (AACR) 2018 conference, which will be held in Chicago on April 16 Professor Wu Yilong, chief research professor at CheckMate-078, said: "the incidence rate of lung cancer in China continues to rise, and is the leading cause of cancer deaths In the checkmate-078 study, about 90% of the subjects were from China This study is the first to confirm that compared with chemotherapy, immunotherapy drug nivolumab can significantly improve a number of study endpoints, including total survival This provides a new potential treatment option for advanced non-small cell lung cancer patients, and has a breakthrough significance " Opdivo's listing application in China was accepted by CDE in December 2017 The target indication is treated non-small cell lung cancer, and it is qualified for priority review Sabine Maier, MD, head of breast cancer development at Bristol Myers Squibb, said: "nivolumab is the only PD-1 inhibitor that has shown overall survival benefit compared to chemotherapy in three randomized phase III clinical studies of lung cancer The positive results of checkmate-078 are consistent with those of checkmate-017 and-057 Thanks to these two international large-scale clinical studies, nivolumab has become the standard treatment for squamous and non squamous NSCLC patients in most countries and regions of the world These clinical studies demonstrate our commitment to bringing innovative drugs to patients " Lung cancer is the leading cause of cancer death in the world According to the World Health Organization, more than 1.7 million people die of lung cancer every year The incidence rate of lung cancer is the highest in China, and 730 thousand cases were reported in 2015 It is reported that 68% of lung cancer patients in China are in advanced stage at the time of diagnosis NSCLC is the most common type of lung cancer, accounting for 85% of all lung cancer patients, of which 25% - 30% are squamous cell carcinoma, 50% - 65% are non squamous non-small cell lung cancer The survival rate of patients was highly correlated with tumor stage and type at the time of diagnosis.