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 15th May 2014
Merck Serono

Merck Serono Announces A New Retrospective Clinical Trial Analysis That Shows 28.4 months Median Overall Survival for Metastatic Colorectal Cancer Patients with RAS Wild-Type Tumours Receiving Erbitux plus FOLFIRI

Merck Serono , the biopharmaceutical division of Merck, today announced new biomarker findings from a retrospective analysis of the completed Phase III study CRYSTAL that compared Erbitux® (cetuximab) plus FOLFIRI with FOLFIRI alone . The analysis involved a subgroup of patients with KRAS wild-type (exon 2) metastatic colorectal cancer (mCRC). An increase in median Overall Survival (mOS) was observed in patients with RAS wild-type tumours when Erbitux was added to FOLFIRI in 1st line mCRC.1 The new data, now published online, ahead of the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting (May 30–June 3) will be presented during the Gastrointestinal (Colorectal) session on June 2, 2014 from 10:00 to 10:12 am. The results of this analysis reinforce Merck’s commitment to improve patient care, and underpins Merck’s leading role in the area of personalised cancer care.

In this new analysis, 430 (65% of 666 patients) patient tumour samples with wild-type KRAS (exon 2) status were assessed for additional RAS mutations (defined as mutations in exons 3 or 4 of KRAS and/or exons 2, 3 or 4 of NRAS). Of these, 367 were RAS wild-type, while 63 presented a mutation. The analysis shows a 27.7% increase in response rate (RR), a 3.0-month increase in median progression-free survival (PFS), and an 8.2-month increase in median overall survival (OS) in mCRC patients with RAS wild-type tumours receiving 1st line Erbitux plus FOLFIRI (n=178), compared with patients receiving FOLFIRI alone (n=189) (RR: 66.3% vs. 38.6%, respectively; odds ratio: 3.11; 95% confidence interval [CI]: 2.03–4.78; p<0.0001; PFS: median 11.4 months vs. 8.4 months, respectively; hazard ratio [HR]: 0.56; 95% CI: 0.41–0.76; p=0.0002; OS: median 28.4 months vs. 20.2 months, respectively; HR: 0.69; 95% CI: 0.54–0.88; p=0.0024).

Professor Will Steward , Professor of Medical Oncology, University of Leicester , Leicester, said “With just over a hundred new cases of colorectal cancer diagnosed in the UK each day, today’s news provides valuable information which will help us manage this disease. Once again, this data reinforces the role of personalised medicines and the critical need for RAS testing in patients.”

Following an update to the Erbitux label that was approved by the European Commission in December 2013, Erbitux is now indicated for the treatment of patients with epidermal growth factor receptor-expressing RAS wild-type mCRC in combination with irinotecan-based chemotherapy, in 1st line in combination with FOLFOX, or as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan. Erbitux is contraindicated in combination with oxaliplatin-containing chemotherapy in patients with mutant RAS mCRC or for whom RAS mCRC status is unknown.

About CRYSTAL CRYSTAL (Cetuximab combined with iRinotecan in 1st-line therapY for metaSTatic colorectAL cancer) was a randomised, Phase III study involving 1,198 chemo-naïve patients with EGFR-expressing mCRC in Stage IV, of whom 666 had confirmed KRAS wild-type (exon 2) tumours. The study showed that progression-free survival, overall survival time and response rate were significantly better in patients with KRAS wild-type mCRC who received Erbitux plus FOLFIRI, compared with FOLFIRI alone About Colorectal Cancer.

Colorectal Cancer (CRC) is the second most common cancer worldwide, with an estimated incidence of more than 1.36 million new cases annually.4 An estimated 694,000 deaths from CRC occur worldwide every year, accounting for 8.5% of all cancer deaths and making it the fourth most common cause of death from cancer.4 Almost 55% of CRC cases are diagnosed in developed regions of the world, and incidence and mortality rates are substantially higher in men than in women.

*CRYSTAL: Cetuximab combined with iRinotecan in 1st-line therapY for metaSTatic colorectAL cancer

Alison MacKenzie Phone: +44 (0)207 861 2803


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