Early Tumor Shrinkage
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Home / International News / Press Releases / 2010 / October / October 11, 2010
Early Tumor Shrinkage with 1st Line Erbitux Therapy Leads to Longest-Ever Median Survival in KRAS Wild-Type mCRC
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Early Tumor Shrinkage with 1st Line Erbitux Therapy Leads to Longest-Ever Median Survival in KRAS Wild-Type mCRC

Milan, Italy and Darmstadt, Germany

Merck Serono, a division of Merck KGaA, Darmstadt, Germany has announced that new data presented today at the 35th Congress of the European Society for Medical Oncology (ESMO) have shown that patients with KRAS wild-type metastatic colorectal cancer (mCRC) who experienced early tumor shrinkage (within 8 weeks) during 1st line Erbitux® (cetuximab) based treatment lived a median of 28.3 months.1 Such a correlation between early tumor shrinkage and long-term survival was not observed in the chemotherapy-alone arm, in which survival did not exceed 21 months.

“These new data indicate that early tumor shrinkage with personalized Erbitux therapy correlates with significantly improved survival,” said study author Professor Eric Van Cutsem, Professor of Medicine and Digestive Oncology from the University Hospital Gasthuisberg in Leuven, Belgium. “Tumor shrinkage is important for providing symptom relief and vital for increasing the potential for curative surgery. These new findings go a step further in suggesting that early tumor shrinkage may also be an indicator for extended survival for patients treated with an Erbitux-based therapy.”

The Phase III CRYSTAL trial has previously demonstrated that mCRC patients with KRAS wild-type tumors treated with Erbitux achieved a median survival of 23.5 months.2 The new findings, derived from further analysis of the trial data, have shown that patients who experienced early tumor shrinkage with Erbitux-based treatment lived a median of 28.3 months.1 Early tumor shrinkage was defined as a 20% or greater tumor reduction within 8 weeks.

“Erbitux-based treatments have consistently achieved meaningful tumor shrinkage. The correlation between early tumor shrinkage and long-term survival seems to be Erbitux-specific as it has not been reported with any other mCRC therapies,” said Dr. Wolfgang Wein, Executive Vice President for Oncology at Merck Serono. “These data have the potential to establish Erbitux as the first-choice, 1st line therapy for all mCRC patients with KRAS wild-type tumors.”

Other news from Merck Serono at ESMO 2010

Please visit www.globalcancernews.com for further news about Erbitux from ESMO 2010.

aCRYSTAL: Cetuximab combined with iRinotecan in 1st line therapY for metaSTatic colorectAL cancer

References

1 Piessevaux H, et al. ESMO Congress 2010. Abstract No: 596P.

2 Van Cutsem E, et al.. ASCO GI Congress 2010. Abstract No: 281.

For more information on Erbitux in colorectal, head & neck and non-small cell lung cancer, please visit: www.globalcancernews.com.

About Erbitux

Erbitux® is a first-in-class and highly active IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of Erbitux is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth.

The most commonly reported side effect with Erbitux is an acne-like skin rash that seems to be correlated with a good response to therapy. In approximately 5% of patients, hypersensitivity reactions may occur during treatment with Erbitux; about half of these reactions are severe.

Erbitux has already obtained market authorization in 80 countries. It has been approved for the treatment of colorectal cancer in 80 countries and for the treatment of squamous cell carcinoma of the head and neck (SCCHN) in 77 countries:

Merck licensed the right to market Erbitux outside the US and Canada from ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, in 1998. In Japan, ImClone, Bristol-Myers Squibb Company and Merck jointly develop and commercialize Erbitux. Merck has an ongoing commitment to the advancement of oncology treatment and is currently investigating novel therapies in highly targeted areas, such as the use of Erbitux in colorectal cancer, squamous cell carcinoma of the head and neck and non-small cell lung cancer. Merck has also acquired the rights for the cancer treatment UFT® (tegafur-uracil) – an oral chemotherapy administered with folinic acid (FA) for the first-line treatment of metastatic colorectal cancer.

Merck is also investigating among other potential cancer treatments the use of Stimuvax® (BLP25 Liposome Vaccine) in the treatment of non-small cell lung cancer. The vaccine was granted fast-track status in September 2004 by the FDA. Merck obtained the exclusive worldwide licensing rights from Oncothyreon Inc., Seattle, Washington, USA.

In addition, Merck is developing cilengitide, which is the first in a new class of investigational anti-cancer therapies called integrin inhibitors to reach Phase III development; it is currently being investigated for the treatment of glioblastoma, SCCHN and NSCLC. Integrin inhibitors are thought to work by targeting the tumor and its vasculature.

About Merck Serono

Merck Serono is the division for innovative prescription pharmaceuticals of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical company. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. In the United States and Canada, EMD Serono operates through separately incorporated affiliates.

Merck Serono has leading brands serving patients with cancer (Erbitux®, cetuximab), multiple sclerosis (Rebif®, interferon beta-1a), infertility (Gonal-f®, follitropin alpha), endocrine and metabolic disorders (Saizen® and Serostim®, somatropin), (Kuvan®, sapropterin dihydrochloride) as well as cardiometabolic diseases (Glucophage®, metformin), (Concor®, bisoprolol), (Euthyrox®, levothyroxine). Not all products are available in all markets.

With an annual R&D expenditure of more than 1bn, Merck Serono is committed to growing its business in specialist-focused therapeutic areas including neurodegenerative diseases, oncology, fertility and endocrinology, as well as new areas potentially arising out of research and development in autoimmune and inflammatory diseases.

About Merck

Merck is a global pharmaceutical and chemical company with total revenues of 7.7 billion in 2009, a history that began in 1668, and a future shaped by approximately 40,000 (including Merck Millipore) employees in 64 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

For more information, please visit www.merckserono.com or www.merck.de.

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Source:Business Wire (Business Wire India)

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