Commenting on the news that the National Health Service’s cost watchdog has recommended Erbitux for use in treating some colon cancer patients, Wolfgang Wein, Merck Serono’s executive vice president for oncology says it was a powerful signal that personalising treatment - the theme of this year’s American Society of Clinical Oncology meeting in Orlando - was the right way forward.

Last year the big news at ASCO was the revelation that colorectal cancer patients whose tumours showed a wild type KRAS gene responded extremely well to the company’s EGFR-targeting antibody Erbitux (cetuximab), while those with mutant KRAS derived no benefit. Patients with WT KRAS had a better progression-free survival and if their metastases were confined to the liver, they had the chance of undergoing surgery following treatment and in 40% of cases having all traces of cancer removed – effectively a cure.

“We are well positioned tying Erbitux in CRC to the predictive biomarker of KRAS. Where drugs lack a predictive biomarker there is always a question of how much treatment is wasted,” he remarked. The company is actively researching predictive and prognostic biomarkers to guide treatment for lung cancer and head and neck cancers where KRAS has proved irrelevant.

Although the European licence for Erbitux was updated to indicate its use only for patients with WT KRAS, the market had grown rather than contracted as clinicians became more confident about the drug’s efficacy, Dr Wein said. Where trials include only patients with WT KRAS tumours, the response rate is the highest ever seen and progression-free survival rates are very favourable.

Despite a slow down in the third quarter last year whilst clinicians gained access to KRAS-testing technology, the drug’s use over the year has been accelerating, he noted. Expansion is linked to its first-line indication in mCRC and its launch as a first-line therapy for squamous cell cancers of head and neck. Approval for first-line use in non-small cell lung cancer following a positive median overall survival outcome in the FLEX trial, is expected

Launched in 2004, Erbitux is one of Merck Serono's leading performers. With total annual sales in pharmaceuticals of almost 5 billion euros, Erbitux sales contributed a substantial proportion. Sales grew from 145 million euros in the fourth quarter of 2008 to 162 million euros in the first quarter this year. “We are on track to reaching our declared goal of achieving 1 billion euro total sales for Erbitux by 2010,” Dr Wein added.

Merck Serono is growing its oncology business by expanding the role for Erbitux in other cancer areas. It has a Phase II trial programme in triple-negative breast cancer and is investigating Erbitux as a treatment for stomach cancer in a trial led by German investigators. A trial is also in progress testing Erbitux in the adjuvant setting in CRC – a potentially important role, he said.

The company has high hopes for its late-stage pipeline products, the integrin inhibitor cilengitide and the therapeutic lung cancer vaccine, Stimuvax. Phase II data for Stimuvax showed a remarkable outcome for patients with stage IIIb local regional disease, some of whom are still alive and receiving Stimuvax eight years on. In fact survivors include two patients with stage IV lung cancer who would normally expect to survive less than one year, he said. Updated data on survivors will be presented later this year. Meanwhile a Phase III trial is recruiting well and will give a more definitive appraisal of the vaccine’s potential when it reports, Dr Wein concluded.