Abstracts on Merck Serono oncology treatments to be presented at ECCO and ESMO

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, continues to drive the global effort to ensure patients receive personalized cancer therapies. A total of 17 abstracts concerning Merck Serono oncology treatments will be presented at the joint 15^th Congress of the European Cancer Organisation (ECCO) and 34^th Congress of the European Society for Medical Oncology (ESMO), to be held in Berlin from 20-24 September 2009.

At the meeting, Merck Serono, its partners and independent researchers will be presenting new data on Erbitux^® (cetuximab) from the major COIN^a, CRYSTAL^b and OPUS^c studies in metastatic colorectal cancer (mCRC), as well as the results of a meta-analysis of four trials of Erbitux in non-small cell lung cancer (NSCLC). In addition, Erbitux data involving potential new disease areas and novel combination therapy regimens will be presented.

Elmar Schnee, member of the Merck Executive Board and President of the Merck Serono division, explains: “Erbitux has broken the barrier between targeted therapies and personalized cancer care in colorectal cancer. The modern understanding of cancer biology has shifted oncology treatment from one-size fits all to an adapted and therefore more responsible approach to cancer care.”

Colorectal cancer (CRC)

• The independent COIN study is the largest>st-line treatment of mCRC and results due to be presented at the ECCO/ESMO congress will add to our understanding of the benefit of personalized therapies in the treatment of this aggressive disease.
• A meta-analysis of the CRYSTAL and OPUS studies, combining Erbitux with chemotherapy as 1^st-line treatment for patients with mCRC, with results according to KRAS status, is expected to reinforce the key role of clinical biomarkers in this indication.
• Final results from a Spanish Phase II study of Erbitux in combination with capecitabine in the 1^st-line treatment of elderly patients with advanced CRC will be also be presented.

Non-small cell lung cancer (NSCLC)

• A meta-analysis of four key studies of Erbitux in NSCLC – looking at the key endpoints of overall survival and progression-free survival – will be presented for the first time at a European congress.

Squamous cell carcinoma of the head and neck (SCCHN)

• Merck Serono will be presenting preliminary data from the Phase I/II ADVANTAGE trial for cilengitide, an integrin inhibitor, in a study assessing the potential utility of this investigational targeted anti-cancer agent in SCCHN.

Gastric and rectal cancers

• Data from an ongoing Phase II study investigating the potential of Erbitux in combination with an irinotecan-based regimen as a 1^st-line treatment for advanced gastric cancer will be presented, as well as a study that used Erbitux as a neoadjuvant therapy in locally advanced resectable rectal cancer when combined with capecitabine and radiotherapy (RT).

Dr. Wolfgang Wein, Executive Vice President, Oncology, Merck Serono concluded: “Combination really is key in oncology and these studies are tangible results based on our strategic imperative to advance targeted therapies to the next level of personalized cancer care. We are continuing to explore multiple combination therapies that enable physicians to choose the best treatment regimens based on patient need.”

^aCOIN: A Phase III trial comparing either COntinuous chemotherapy plus cetuximab or INtermittent chemotherapy with standard continuous palliative combination chemotherapy with oxaliplatin and a fluoropyrimidine in first line treatment of metastatic colorectal cancer

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

^cOPUS: OxaliPlatin and cetUximab in firSt-line treatment of mCRC