The first I-O / I-O combination therapy for advanced renal cell carcinoma patients was approved in Europe

January 15, 2019 / Meitong news agency / -- Bristol Myers Squibb (NYSE: BMY) announced on January 14 that the 3 mg / kg nevulizumab (odevo) combined with 1 mg / kg epimumumab ("low dose") program has been approved by the European Commission for the first-line treatment of patients with advanced renal cell carcinoma (RCC) This is the first EU approved I-O combined therapy for this kind of patients "At present, less than 50% of patients with metastatic renal cell carcinoma can survive for more than two years, and almost no cases of complete remission have been found, which highlights the urgent need for new therapies for renal cell carcinoma." Bernard escudier, M.D., former chairman of the urogenital cancer committee of Gustave roussy, France, said: "this approval provides new first-line treatment options for patients in the European Union Compared with sunitinib, the complete remission rate of this I-O combined therapy is close to 10%, the overall survival rate (OS) is significantly improved, and there are lower level 3 and level 4 adverse reactions " This approval is based on the results of the checkmate-214 phase III clinical study The trial was terminated early after the planned interim analysis The results showed that the combination of nevulizumab and low dose epimumumab could significantly improve OS Compared with the current standard treatment of sunitinib, the risk of death in middle and high risk patients was reduced by 37% (HR 0.63; 99.8% CI: 0.44 to 0.89; P < 0.0001) Regardless of the level of PD-L1 expression, OS benefits were observed Up to now, the median overall survival of patients treated with nafulizumab combined with low-dose epimumumab has not reached (95% CI: 28.2 months to inestimable [ne]), while that of patients treated with sunitinib is 25.9 months At the same time, the combination of nevulizumab and low-dose epimumab showed a higher objective response rate of 41.6% (95% CI: 36.9 to 46.5; P < 0.0001; n = 177 / 425), and sunitinib was 26.5% (95% CI: 22.4 to 31.0; n = 112 / 422) The complete remission rate was 9.4% in the combination group and 1.2% in the sunitinib group In response patients, the median remission time of patients who received the combination therapy of nevulizumab and low-dose epimumumab has not yet reached (95% CI: 21.8 months to NE), and that of the sunitinib group is 18.2 months (95% CI: 14.8 months to NE) In addition, the combination of nevulizumab and low-dose epimumumab resulted in fewer grade 3 or 4 adverse events (65% vs 76%) compared with sunitinib "Based on the significant survival benefit data from the checkmate-214 clinical study, we are very pleased that the European Commission has approved the treatment plan of nevulizumab combined with low-dose epimumumab." Chris boerner, chief business officer of Bristol Myers Squibb, said: "this approval will help us further achieve the goal of innovating cancer treatment, improving patients' quality of life and achieving long-term survival benefits." About checkmate-214 checkmate-214 is a randomized, open label, phase III clinical study designed to evaluate the efficacy of 3 mg / kg nafulizumab combined with 1 mg / kg epimumumab compared with sunitinib in the treatment of patients with primary advanced renal cell carcinoma (RCC) In the middle and high risk study population, 425 patients were treated with 3 mg / kg nafulizumab combined with 1 mg / kg epimumumab once every 3 weeks After 4 consecutive cycles, 3 mg / kg nafulizumab was used in sequence once every 2 weeks 422 patients were treated with 50 mg sunitinib once a day for 4 weeks After 2 weeks' rest, the next cycle was continued The recommended dosage of the combination of nevulizumab and low-dose epizumab is: 3 mg / kg of nevulizumab, followed by 1 mg / kg of epizumab, which is injected intravenously on the same day, each time for more than 30 minutes, once every 3 weeks, four times in total After 4 times of combined administration, 240 mg of nafulizumab should be given intravenously every 2 weeks for more than 30 minutes, or 480 mg for more than 60 minutes every 4 weeks, until the disease progresses or intolerable toxicity appears The composite primary efficacy endpoint of this trial was the overall survival period, objective response rate (complete response + partial response) and progression free survival period determined by independent imaging Committee (irrc) PD-L1 status was not considered in this trial Renal cell carcinoma (RCC) is the most common type of renal cancer in adults, with an annual death toll of more than 140000 worldwide Among them, renal clear cell carcinoma is the most common type of renal cell carcinoma, accounting for 80% to 90% of the total number of patients with renal cell carcinoma The incidence rate of renal cell carcinoma is two times that of female patients, and the highest incidence is in North America and Europe Globally, the 5-year survival rate of advanced or metastatic renal cancer is 8% Bristol Myers Squibb: to promote the development of cancer research in Bristol Myers Squibb, all patient-centered is our purpose Our vision is to improve the quality of life of cancer patients and achieve long-term survival With the promotion of transformation science, we have applied our deep scientific experience in the field of oncology and immune Oncology (I-O) research through a unique multi-disciplinary collaborative way to provide patients with individualized and innovative treatment programs to meet different needs Our researchers are focusing on the development of diverse and targeted drug research and development pipelines, aiming to solve the complex and specific interactions among tumors, tumor microenvironment and immune system according to different immune system signaling pathways We not only seek internal innovation, but also advocate exchanges and cooperation with academia, governments, patient organizations and biotechnology companies Just like the continuous innovation of I-O treatment drugs, we will continue to help patients realize the promise of continuous drug change About opdivo ® (odivotm) odivotm is a PD-1 immunocheckpoint inhibitor that uniquely uses the body's own immune system to help the body recover its anti-tumor immune response By using the characteristics of human autoimmune system to fight against cancer, odivotm has become an important treatment option for a variety of tumor types Based on Bristol Myers Squibb's scientific expertise in the field of I-O therapy, odivotm has the world's leading research and development projects, covering various stages of clinical trials of various tumor types, including stage III clinical trials Up to now, more than 25000 patients have been enrolled in the clinical R & D project of odelvotem The clinical trials of odivotm will help to deepen the understanding of the potential role of biomarkers in patients' treatment options, especially in identifying how patients with different levels of PD-L1 expression can benefit from odivotm In July 2014, odivotm became the first PD-1 immunosuppressive checkpoint inhibitor approved by regulatory authorities in the world At present, odivotm has been approved in more than 65 regions, including the United States, the European Union, Japan and China In October 2015, the combination therapy of odivotm and epimumumab for melanoma became the first I-O drug combination therapy approved by regulatory authorities, and has been approved in more than 50 regions, including the United States and the European Union Regarding the cooperation between Bristol Myers Squibb and Ono Pharmaceutical Co., Ltd in 2011, Bristol Myers Squibb signed a cooperation agreement with Ono Pharmaceutical Co., Ltd to obtain the franchise of developing and listing nivolumab in the world (except Japan, South Korea and Taiwan) Ono pharmaceutical retained the ownership of the compound On July 23, 2014, Bristol Myers Squibb and Ono pharmaceutical again signed a strategic cooperation agreement on the joint development and commercialization of multiple immune drugs, including single drug treatment and combination therapy, to help solve the needs of cancer patients in Japan, South Korea and Taiwan About Bristol Myers Squibb, a global biopharmaceutical enterprise with the mission of "developing and providing innovative drugs to help patients overcome serious diseases" For more information, please visit bms.com or follow Bristol Myers Squibb on LinkedIn, twitter, youtube and Facebook Note: nvolumab is only approved in mainland China for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have been treated with EGFR gene mutation negative and anaplastic lymphoma kinase (ALK) negative, who have been treated with platinum containing chemotherapy for disease progression or intolerability Epilimumab has not yet been approved for marketing in mainland China.