Daiichi Sankyo Announces Discontinuation of Phase 3 Clinical Trial in Japan of Nimotuzumab (DE-766) in Lung Cancer

  • Nimotuzumab (DE-766),Cancer,Daiichi Sankyo



                                                


TOKYO, Japan (April 25, 2014) - Daiichi Sankyo Company, Limited announced today the discontinuation of the phase 3 clinical trial conducted in Japan for nimotuzumab (DE-766) in Lung Cancer.

 

The phase 3 clinical trial was a multicenter, randomized, double-blind, placebo-controlled study investigating nimotuzumab for first-line therapy in patients with unresectable and locally advanced squamous cell lung cancer. Patients received either nimotuzumab in combination with concurrent chemoradiotherapy or a placebo in combination with concurrent chemoradiotherapy.

 

The study was discontinued based on the recent recommendation of the Independent Data Monitoring Committee which observed safety issues in certain patients who received a combination of cisplatin, vinorelbine, radiotherapy, and nimotuzumab.

 

About Unresectable and Locally Advanced Squamous Cell Lung Cancer

In Japan, lung cancer is the first leading cause of cancer death with about 70,000 deaths in 2011.i Non-small cell lung cancer (adenocarcinoma, squamous cell carcinoma, and large cell carcinoma) occupies more than 80 percent of lung cancer. Concurrent chemoradiotherapy for a radical cure is currently used as the standard treatment for patients with stage III locally advanced non-small cell lung cancer, in which radical surgery is not possible but radiotherapy is.ii Of these cases, between 30 and 40 percent are squamous cell carcinoma and EGFR is known to be overexpressed.iii

 

About Nimotuzumab and EGFR

Nimotuzumab is an intravenously administered recombinant humanized monoclonal antibody directed against human Epidermal Growth Factor Receptor (EGFR) and is produced by CIMAB S.A. (Cuba). nimotuzumab blocks the binding of Epidermal Growth Factor (EGF) to its receptor interfering with the cell signaling pathway. Nimotuzumab has been approved for head and neck cancer, glioma, and esophageal cancer in several countries and used in 29 completed and 26 on-going trials worldwide without any major safety concern so far.  EGFR is known to be overexpressed in a wide variety of human tumors.iv Overexpression of EGFR in tumors correlates with increased metastasis, decreased survival, and a poor prognosis. It is known that EGFR is activated by exposure to radiation.

In 2006, Daiichi Sankyo introduced nimotuzumab from CIMAB S.A.(Cuba) and CIMYM BioSciences Inc. (Canada) and has the rights to develop and commercialize in Japan.

 

 

 Reference

i) Vital Statistics of Japan (Ministry of Health, Labour and Welfare); 2011.

ii) Lung Cancer Clinical Practice Guidelines (Japan Lung Cancer Society); 2012.

iii) Ito T, Ishii G, Nagai K, et al. Low podoplanin expression of tumor cells predicts poor prognosis in pathological stage IB squamous cell carcinoma of the lung, tissue microarray analysis of 136 patients using 24 antibodies. Lung Cancer 2009; 63(3):418–424.

 iv) Salomon DS, Brandt R, Ciardiello F, et al. Epidermal growth factor-related peptides and their receptors in human malignancies. Crit Rev Oncol Hematol 1995; 19:183-232.




This link: http://www.chemcd.com/news/44.html

The ChemCD compiler finishing, shall not be reproduced without permission, for reprint please indicate the source

This link:http://www.chemcd.com/news/44.html

The ChemCD compiler finishing, shall not be reproduced without permission, for reprint please indicate the source。

comments powered by Disqus

Categories

Related News

The future of cancer research: In your medicine cabinet?

2014/07/25 - The Repurposing Drugs in Oncology (ReDO) project, an international collaboration between Anticancer Fund, Belgium, and US based GlobalCures, finds that existing and widely-used non-cancer drugs may represent a relatively untapped source of novel therapies for cancer.

Scientists test nanoparticle 'alarm clock' to awaken immune systems put to sleep by cancer

2014/07/28 - Researchers at Dartmouth-Hitchcock Norris Cotton Cancer Center are exploring ways to wake up the immune system so it recognizes and attacks invading cancer cells. Tumors protect themselves by tricking the immune system into accepting everything as normal, even while cancer cells are dividing and spreading.

Health Canada Approves ABRAXANE Plus Gemcitabine for First-Line Treatment of Patients with Metastatic Pancreatic Cancer

2014/08/08 - Health Canada has approved PrABRAXANE for Injectable Suspension for first-line treatment of adult patients with metastatic pancreatic cancer. The approval is welcome news for Canadians who are diagnosed with metastatic pancreatic cancer, and represents the first approved treatment for this disease in nearly two decades.

Otsuka wins early FDA approval for a colorectal cancer combo drug

2015/09/23 - Japanese drugmaker Otsuka won FDA approval for a two-drug therapy for colorectal cancer, planning to market the combination as a treatment for advanced forms of the disease.

MYC/PGC-1α Balance Determines the Metabolic Phenotype and Plasticity of Pancreatic Cancer Stem Cells

2015/09/16 - The anti-diabetic drug metformin targets pancreatic cancer stem cells (CSCs), but not their differentiated progenies (non-CSCs), which may be related to distinct metabolic phenotypes.

Celgene's Abraxane takes another hit from cost-effectiveness gatekeepers

2015/09/21 - Celgene's ($CELG) Abraxane can't catch a break in England. Soon after losing coverage for pancreatic cancer on the country's dedicated Cancer Drugs Fund, the treatment got another thumbs-down from its official cost-effectiveness watchdogs.