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In alignment with this year’s American Society of Clinical Oncology (ASCO) Annual Meeting theme, ‘Patients, Pathways, Progress’, Merck Serono, a division of Merck KGaA, Darmstadt, Germany, has announced the presentation of a retrospective analysis of the CRYSTAL trial demonstrating that Erbitux® (cetuximab) significantly improves outcomes in metastatic colorectal cancer (mCRC) patients with KRAS wild-type tumours, even if they have advanced metastatic disease which has spread beyond the liver.
This analysis examined the benefits of 1st line Erbitux in combination with standard chemotherapy (FOLFIRI) in KRAS wild-type patients, dependent on metastatic site. Results showed that patients with non-liver limited disease (non-LLD) treated with Erbitux and FOLFIRI experienced a significant increase in overall survival of more than five months, compared to patients treated with chemotherapy alone (22.5 vs. 17.4 months, p=0.013). Given that the majority of mCRC patients fall into this more advanced category (approximately 70% of patients have non-LLD), these results provide strong support for the value of Erbitux combination therapy in helping physicians achieve a key treatment goal for KRAS wild-type mCRC patients.
In addition, the new analysis examined the impact of Erbitux combination therapy on LLD patients’ ability to undergo potentially curative surgery (i.e. complete resection: R0). The highest R0 rate was seen in patients with LLD treated with Erbitux plus FOLFIRI, in whom a 2.58-fold increase in the chance of R0 versus CT alone while not reaching statistical significance (13.2% vs. 5.6%, odds ratio 2.58, p=0.125) was demonstrated. These results support previous findings from CRYSTAL and other key Erbitux trials, in which significant response rates and corresponding increases in R0 rates were seen across the KRAS wild-type patient population with the addition of Erbitux to standard chemotherapy.
“For most patients with advanced cancer, the chance to live longer, or even be cured, are the most important benefits a treatment can offer,” said Professor Claus Henning Köhne, lead author of the ASCO publication from the Klinikum Oldenburg, Germany. “These new findings from CRYSTAL are therefore important for both LLD and non-LLD patients, as we have a strong sign that both groups benefit from Erbitux combination therapy.”
These findings point to the growing importance of Erbitux in mCRC and the value of personalising cancer care via a stratified medicine approach.
“In the palliation of patients where the tumour has spread beyond the liver prolonged survival is essential,” said Dr. Wolfgang Wein, Executive Vice President, Oncology, Merck Serono.