Merck Serono: Survey Shows The Number Of MCRC Patients Tested For KRAS Jumped 50% In 12 Months

Main Category: Colorectal Cancer
Also Included In: Cancer / Oncology
Article Date: 04 Jul 2010 - 0:00 PDT

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Merck Serono, a division of Merck KGaA, Darmstadt, Germany, has revealed new results from a global survey demonstrating that 66% of patients with metastatic colorectal cancer (mCRC) are now tested for KRAS to determine if they could benefit from a personalized therapy, such as Erbitux® (cetuximab). This represents a 50% increase in levels of KRAS testing in just one year.1 These figures indicate that physicians across the world are becoming increasingly aware that testing patients' KRAS status enables them to offer each patient the treatment most likely to improve his or her therapeutic outcome.

"KRAS testing is a critical tool for allowing physicians to know exactly which treatments are most suitable for their mCRC patients," said Professor Fortunato Ciardiello, Lead Investigator and Professor of Medical Oncology at The Second University of Naples, Italy. "This survey shows that more and more physicians are convinced by the strength of the evidence and are conducting KRAS testing as standard. This way, they can ensure their patients receive treatment which is personalized to them and increases their chance of response and even cure."

This survey, which provides the latest figures from a yearly evaluation of physician awareness and usage KRAS testing in Europe, Asia and Latin America, shows a notable increase in the number of physicians that test KRAS status as a standard part of the diagnostic procedure for mCRC. For example, at the start of 2009 - less than a year after new evidence demonstrated the value of Erbitux for treating mCRC patients with KRAS wild-type tumors2 - 33% of physicians in Europe already routinely tested KRAS status at diagnosis of mCRC. By 2010, this figure has more than doubled to 73%. This is in remarkable contrast to the small percentage of mCRC patients whose KRAS status was tested in 2008.

These 2010 results follow hot on the heels of 2009 survey figures presented at the ASCO annual meeting in early June, 2010, which demonstrated that Erbitux has become a standard of care for patients with confirmed wild-type tumors.3

"These are very positive findings which demonstrate that in only two years the management of mCRC has been revolutionized, greatly to the benefit of patients," said Dr. Wolfgang Wein, Executive Vice President, Oncology, Merck Serono. "KRAS testing has allowed mCRC patients to receive personalized therapy, such as with Erbitux, that is tailored to their specific disease and which provides them with a higher chance of responding to treatment and living longer."

This was underlined at ASCO 2010 by the presentation of the latest Erbitux data from the CRYSTALa study, which reinforces the drug's significant overall survival benefit in mCRC patients with KRAS wild-type tumors versus FOLFIRI alone.4

This latest survey demonstrates that the vast majority of healthcare professionals are performing KRAS testing as standard and more and more patients are being tested for KRAS, reaching for example 76 percent in Europe. The significant yearly increases in levels of KRAS testing illustrate that physicians across the world are taking an increasingly evidence-based approach to the management of mCRC. They also reflect the growing body of evidence that the addition of Erbitux to the standard chemotherapy regimen, FOLFIRI, significantly improves outcomes, including overall survival (OS), in mCRC patients with KRAS wild-type tumors.5-7

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

References

1. Ciardiello F, et al. WCGIC 2010. Abstract No: PD-0003.
2. Van Cutsem, E. et al. ASCO Annual Meeting 2008; Abstract No: 2.
3. Ciardiello F, et al. ASCO Annual Meeting 2010; Abstract No: e14074.
4. Van Cutsem E, et al. ASCO Annual Meeting 2010; Abstract No: 3570.
5. Van Cutsem E, et al. ACSO Annual Meeting 2007; Abstract No: 4000.
6. Van Cutsem E, et al. ECCO/ESMO Congress 2009; Abstract No: 6077.
7. Bokemeyer C, et al.ECCO/ESMO Congress 2009; Abstract No: 6079.

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:

- December 2003 (Switzerland), February 2004 (USA), June 2004 (EU) and followed by other countries: for use in combination with irinotecan in patients with EGFR-expressing mCRC (metastatic colorectal cancer) who have failed prior irinotecan therapy. In addition, Erbitux is also approved for single-agent use in further countries.

- April 2006 (EU) and followed by other countries: for use in combination with radiotherapy for the treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN). In further countries, Erbitux is also approved as monotherapy in patients with recurrent and/or metastatic SCCHN who failed prior chemotherapy.

- July 2008 (EU): license was updated for the treatment of patients with epidermal growth factor receptor (EGFR) expressing, KRAS wild-type mCRC in combination with chemotherapy and as a single agent in patients who have failed oxaliplatin-and irinotecan-based therapy and who are intolerant to irinotecan.

- July 2008 (Japan): for use in combination with irinotecan in patients with EGFR-expressing mCRC who have failed prior irinotecan therapy

- In November 2008 (EU): license was updated for the use in combination with platinum-based chemotherapy in patients with recurrent and/or metastatic SCCHN

- March 2010 (Japan): label extended to use in combination with chemotherapy in the 1st-line treatment for patients with epidermal growth factor receptor (EGFR)-expressing, curatively unresectable (inoperable), advanced or recurrent colorectal cancer (mCRC) carrying the KRAS wild-type gene.

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 and breast 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.

*Currently on clinical hold by the FDA / suspended

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.

Source:
Merck Serono

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