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    Home > Active Ingredient News > Antitumor Therapy > Melanoma immunotherapy! Opdivo four week protocol is approved by European Union for adjuvant treatment of patients with lymph node involvement or metastasis

    Melanoma immunotherapy! Opdivo four week protocol is approved by European Union for adjuvant treatment of patients with lymph node involvement or metastasis

    • Last Update: 2019-10-27
    • Source: Internet
    • Author: User
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    October 27, 2019 / BIOON / -- tumor immunotherapy giant BMS recently announced that the European Commission (EC) has approved two drug delivery schemes of PD-1 tumor immunotherapy opdivo (Chinese trade name: odivo, common name: nivolumab, nevuliumab), which are used for lymph node involvement or metastatic melanoma that has been completely removed Auxiliary treatment of patients The two regimens were: (1) 240mg dose every 2 Monday (Q2W), intravenous infusion time 30 minutes; (2) 480mg dose every 4 Monday (Q4W), intravenous infusion time 60 minutes Ralu vladb, head of BMS product design and delivery development team, said: "the approval by the European Commission of a two-week and four week regimen of opdivo to assist in the treatment of melanoma is an important milestone for melanoma patients throughout the European Union, who now have additional treatment flexibility Bristol Myers Squibb is committed to giving cancer patients and their families more flexible treatment options to restore control of their lives to meet their personal needs " Melanoma is a kind of skin cancer, which is characterized by uncontrolled growth of melanocyte in the skin Metastatic melanoma is the most lethal form of the disease, when cancer cells have spread from the surface of the skin to other organs of the body The incidence rate of melanoma has been increasing steadily in the past 30 years In the United States, an estimated 912700 new melanoma cases were confirmed in 2018, with more than 9320 deaths The WHO estimates that by 2035, the incidence rate of melanoma will reach 424102 people, and the number of deaths will reach 94308 Melanoma can be divided into 5 stages (0-4 stages) according to its in situ characteristics, thickness and degree of ulceration, whether the tumor spreads to the lymph node or not, and the extent of tumor spreading beyond the lymph node Stage 3 melanoma usually has reached the local lymph nodes, but has not spread to distant lymph nodes or other parts of the body (metastasis), so it is necessary to resect the primary tumor and related lymph nodes Some patients can also receive postoperative adjuvant treatment Despite surgical resection, most patients experience relapse and metastasis In the early stage, melanoma is mostly curable, but if it spreads to local lymph nodes (stage 3), the survival rate will be reduced by about half In the United States, patients diagnosed with advanced melanoma (stage 4) have a 5-year survival rate of 15% - 20%, and a 10-year survival rate of 10% - 15% Clinically, the effective treatment of tumor has always been surgical resection, in addition to surgical treatment are called adjuvant treatment The purpose of adjuvant therapy is to eliminate the residual micrometastasis, reduce the chance of tumor recurrence and metastasis, and improve the cure rate Early intervention with adjuvant therapy has been shown to be an important factor in reducing the risk of postoperative recurrence in patients with high-risk stage 3 melanoma Approved in July 2014, opdivo is the first PD-1 immunotherapy on the market in the world In terms of melanoma, opdivo has approved three indications: (1) as a single drug therapy for patients with non resectable or metastatic melanoma; (2) in combination with yervoy for patients with non resectable or metastatic melanoma; (3) as an adjuvant therapy for patients with lymph node involvement or metastatic melanoma who have been completely removed At the end of September this year, BMS released the results of three-year efficacy analysis of checkmate-238, a phase III clinical trial of opdivo adjuvant therapy for melanoma This is a randomized, double-blind study in patients with stage 3B / C or stage 4 melanoma (evaluated according to AJCC Cancer staging manual, 7th Edition) who have a high risk of recurrence after complete tumor resection In the study, 906 patients were randomly assigned to receive (1) opdivo once every two weeks, 3 mg / kg intravenously; (2) yevoy once every three weeks, 10 mg / kg intravenously, and then once every 12 weeks In the study, patients were treated until disease progression or unacceptable toxicity was recorded, with a maximum treatment duration of one year The primary end point was relapse free survival (RFs), defined as the time between randomization and the date of first recurrence or death The secondary end point was total survival (OS) During the three-year follow-up, opdivo continued to show RFs advantages over yevoy: higher 3-year relapse free survival (58% vs 45%), and a significant 32% reduction in the risk of disease recurrence (HR = 0.68, P < 0.0001) In addition, compared with yervoy, opdivo continued to show the advantages of DMFS: the 3-year DMFS was higher (66% vs 58%; HR = 0.78, P = 0.044) RFs and DMFS benefits were consistently observed in all key subgroups, including disease stage, BRAF mutation status, and PD-L1 expression As part of the 36 month analysis, no new safety data was generated Dr Jeffrey S Weber, lead investigator of the checkmate-238 study and deputy director of the Permut cancer center at the langney medical center, New York University, said: "for advanced melanoma with high risk of recurrence that has been surgically removed For patients, these three-year data are important because they provide additional evidence to support the long-term benefits of opdivo adjuvant therapy in reducing disease recurrence The continuous separation of the curve shows the long-term potential of opdivo to provide lasting benefits to this patient population " Source of the original text: European Commission approvesopdivo (nivolumab) four week doing schedule for the adjust treatment of adjust patients with melanioma with involvement of lymph nodes or metastatic release who have underground complete research
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