BMS PD-1 immunotherapy Opdivo is approved by the European Union for the treatment of squamous non-small cell lung cancer
July 22, 2015 Source: Bio Valley
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];The king of PD-1/PD-L1 immunotherapy - Bristol-Myers Squibb (BMS) has recently received great news in European regulation. The company's PD-1 immunotherapy Opdivo (nivolumab) has been approved by the European Union for use in the past. Patients with locally advanced or metastatic squamous (SQ) non-small cell lung cancer (NSCLC) who have been treated. The approval marks Opdivo as the first major treatment advancement in the field of squamous non-small cell lung cancer (SQ-NSCLC) over the past 10 years, and it has also become the first and only treatment for metastatic SQ- PD-1 immunotherapy that exhibits overall survival (OS) benefits in the NSCLC population.
Opdivo's approval is based on positive top-line data from two studies (Checkmate-017, -063). Checkmate-017 is a milestone phase III study conducted in patients with advanced squamous non-small cell lung cancer (SQ-NSCLC) during or after treatment with a platinum-containing chemotherapy regimen, with Opdivo (3 mg/kg body weight per 2 Weekly intravenous injections were compared with standard care docetaxel (75 mg/m2, once every 3 weeks).
The data showed that Opdivo showed significant advantages over docetaxel chemotherapy across all endpoints; in terms of overall survival (OS), Opdivo almost doubled the one-year survival rate (42% vs 24%), death The risk was significantly reduced by 41% and the median overall survival was increased by 3.2 months (9.2 months vs 6.0 months). In addition, in terms of progression-free survival (PFS) and overall response rate (ORR), Opdivo showed a statistically significant improvement in clinical significance compared to docetaxel, and treatment benefit was independent of PD-L1 expression status. Checkmate-063 is a phase II study with data showing an expected 1-year survival rate of 41% and a median overall survival (OS) of 8.2 months in the Opdivo treatment group. In the study, Opdivo safety was consistent with previous clinical studies and was more favorable than docetaxel.
In Europe, the incidence and mortality of lung cancer are rising, currently accounting for about 20% of all cancer deaths. Non-small cell lung cancer (NSCLC) is one of the most common forms of lung cancer, accounting for approximately 85% of lung cancer cases. Squamous non-small cell lung cancer (SQ-NSCLC) accounts for 25-30% of all lung cancer cases. In patients with NSCLC who have relapsed or worsened after chemotherapy, the choice of clinical treatment is very limited, and the prognosis is extremely poor. The 5-year survival rate in the world is only about 2%.
Currently, the PD-1/PD-L1 immunization competition is extremely fierce, with a market peak of $35 billion. The leaders in this field include Merck, Bristol-Myers Squibb, Roche, and AstraZeneca. In this competition, Bristol-Myers is far ahead, and its PD-1 immunotherapy Opdivo has received approvals in three major global markets (US, Japan and Europe): Japan (melanoma), the United States (melanoma, non-small cell lung cancer) , Europe (melanoma, non-small cell lung cancer). Merck is close behind, its PD-1 immunotherapy Keytruda has harvested melanoma indications in the United States, and is expected to harvest non-small cell lung cancer indications in October; in Europe, Keytruda is likely to harvest melanoma indications in July. Roche atzolizumab and AstraZeneca MEDI4736 have not yet harvested any indications. The pharmaceutical market research institute evaluatePharma predicts that Opdivo will become the most successful immunotherapy in the PD-1/PD-L1 field, with sales reaching $8.8 billion in 2020, and Keytruda will reach $5.5 billion. Roche's atezolizumab peak is only $2 billion. Dollar.
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, the giants are rapidly advancing their clinical programs to investigate monotherapy and combination therapy for the treatment of multiple cancers to fully exploit the maximum clinical potential of such drugs.
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