Bristol-Myers Opdivo becomes the first tumor immunotherapy for SCCHN in Europe
Bristol-Myers Opdivo is approved by the European Union CHMP and will become the first tumor immunotherapy in Europe for the treatment of head and neck squamous cell carcinoma (SCCHN)
March 29, 2017 - US pharmaceutical giant Bristol-Myers Squibb (BMS) tumor immune pipeline has recently received good news on EU regulation. The European Medicines Agency (EMA) Human Pharmaceutical Products Committee (CHMP) issued a positive opinion recommending the approval of PD-1 immunotherapy Opdivo as a monotherapy for head and neck during or after treatment with a platinum-containing chemotherapy regimen. Treatment of adult patients with squamous cell carcinoma (SCCHN). Opdivo is also the first immuno-oncology preparation to be approved by the European Union for CHMP for platinum-refractory SCCHN. In Europe, as of now, Opdivo has been approved for up to six indications across four unique types of cancer treatment.
In US regulation, Opdivo received FDA approval in November 2016 for the treatment of adult patients with platinum-refractory recurrent or metastatic head and neck squamous cell carcinoma (SCCHN). The approval made Opdivo the first tumor immunotherapy in the US market to receive SCCHN, marking a major milestone in the clinical treatment of SCCHN.
Opdivo received FDA approval and this EU CHMP recommendation was based on data from a Phase III clinical study (CheckMate-141). The study was an open-label, randomized phase III study involving 361 patients with platinum-refractory recurrent or metastatic head and neck squamous cell carcinoma (SCCHN). In the study, patients were randomly assigned to Opdivo in a 2:1 ratio. (3mg/kg, once every 2 weeks) or the treatment plan selected by the investigator (cetuximab/methotrexate/docetaxel) until disease progression or unacceptable toxic effects Stop the drug. The primary endpoint of the study was overall survival (OS), and secondary endpoints included objective response rate (ORR) and progression-free survival (PFS).
According to the Independent Data Monitoring Committee (DMC), the Opdivo treatment group showed significant superiority in overall survival (OS) compared with the control group (median OS: 7.5 months vs 5.1 months), and the risk of death was significant Reduce by 30%.
Head and neck cancer is the seventh most common cancer in the world, with an annual increase of 400,000 to 600,000 new cases and 223,000 to 300,000 deaths per year. The 5-year survival rate of metastatic stage IV head and neck cancer is less than 4%. It is estimated that head and neck squamous cell carcinoma (SCCHN) accounts for approximately 90% of all head and neck cancer cases, and global incidence is expected to increase by 17% in 2012-2022. SCCHN risk factors include smoking and drinking, while in Europe and North America, human papillomavirus (HPV) infection is an increasing trend in oropharyngeal SCCHN.
PD-1/PD-L1 immunotherapy is a new class of anti-cancer immunotherapy that is currently attracting attention. It aims to use the body's own immune system to fight cancer and block cancer cells by blocking PD-1/PD-L1 signaling pathway. It has the potential to treat many types of tumors. At present, a number of pharmaceutical giants including Bristol-Myers Squibb, Merck, Roche and AstraZeneca are rapidly advancing their clinical projects, investigating monotherapy and combination therapy for the treatment of various cancers to thoroughly explore such a category. The greatest clinical potential of the drug.
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