The European Commission has approved nivolumab (Opdivo, Bristol Myers Squibb Company) for head and neck squamous cell carcinoma patients with disease progression during treatment of platinum or platinum, which is based on the results of the CheckMate-141 trial.
PD-1 antibody NMV (Nivolumab, Opdivo, and Bristol Shi Guibao) received FDA approval for the treatment of head and neck cancer since November 2016. The day before, and won the European Commission Wu Na MAb (EC) approved for head and neck squamous cell carcinoma (SCCHN) patients with disease progression based chemotherapy or after platinum
This approval of the European Commission is based on the results of the CheckMate-141 test. CheckMate-141 was compared to patients with relapsed or metastatic SCCHN using drugs used for platinum refractory drugs compared with NMV. The drugs used by the researchers include methotrexate, docetaxel, and cetuximab.
The final results of the test have not yet been made public, and will be announced at the annual meeting of the American Society of Clinical Oncology (ASCO) in June this year.
2016, "new England Journal of Medicine (NEJM) - the results of a pivotal trial published the analysis showed that the median overall survival of patients treated with mAb Na Wu for 7.5 months, and the median overall survival for drug researchers selected patients for only 5.1 months, the risk of therefore, death in patients with decreased 30% (hazard ratio, 0.70; P=0.0101).
There was no significant difference in progression free survival and objective remission rate between the two groups, while progression free survival and objective remission rate were the secondary end points of the trial.
In the CheckMate-141 trial, 49% of the patients treated with nnmv had serious adverse reactions. The most common serious adverse reactions are dyspnea, pneumonia, respiratory failure, inhalation pneumonia, respiratory infection and sepsis. However, further analysis of the test showed that NMV compared with chemotherapy significantly improved the quality of life of the patients.
However, further analysis of the experimental data showed that nivolumab significantly improved the patient's quality of life compared to chemotherapy. According to Medscape Medical News, the 2016 annual meeting of the European Society for oncology published the data.
Head and neck squamous cell carcinoma accounts for about 90% of all cases of head and neck cancer in the world. The clinical treatment of squamous cell carcinoma of the head and neck is very challenging, one expert said. “ in the platinum or platinum based chemotherapy during the progression of disease after head and neck squamous cell carcinoma in adult patients with a debilitating and difficult to cure and the prognosis is very poor fight disease, Dr. Kevin Harrington ” clinical oncologist at the Royal Marsden cancer center in London said.
In the United States, both nadumumumab and Pam monoclonal antibody (pembrolizumab, Keytruda, Merck) were allowed to be used for relapsed or metastatic platinum refractory SCCHN.
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