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News Release

Dr. Raphaela Farrenkopf

Phone +49 6151-72 2274

 Embargoed until 12:30 CET, October 10, 2010

Data presented during 35^th ESMO Congress Poster Presentation II, on October 10 2010, by Professor H Piessevaux: ‘Early tumor shrinkage for the prediction of efficacy of cetuximab in metastatic colorectal cancer (MCRC): analysis from the CRYSTAL study’.

 Early Tumor Shrinkage with 1st Line Erbitux Therapy Leads to Longest-Ever Median Survival in KRAS Wild-Type mCRC

• Further analysis of the CRYSTAL^a trial shows unprecedented median overall survival of 28.3 months for patients who experienced early tumor shrinkage
• This finding further demonstrates the value of Erbitux as the first-choice, 1st line therapy

Milan/Darmstadt, Germany, October 10, 2010 – Merck Serono, a division of Merck KGaA, Darmstadt, Germany has announced that new data presented today at the 35^th 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

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

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

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