Merck KGaA has submitted an indication extension to the European Medicines Agency for the approval of Erbitux in a subgroup of patients with lung cancer based on "a new biomarker principle".
Specifically, the filing deals with Erbitux (cetuximab) in combination with standard first-line platinum-based chemotherapy in patients with advanced or metastatic non-small cell lung cancer with high epidermal growth factor receptor (EGFR) expression. The Darmstadt-based group notes that the submission is based on "a new biomarker analysis of EGFR expression levels in tumours of patients participating in the Phase III FLEX study".
Data from FLEX showed that among patients with high EGFR expression, the response rate was significantly increased by the addition of Erbitux to standard chemotherapy, from 28.1% to 44.4%. Merck says it has analysed further clinical data for the submission and plans to present additional results at upcoming congresses.
The decision to go for a narrower patient population comes after the European regulators rejected Erbitux as a treatment for advanced lung cancer in November 2009. At the time, Merck had hoped that the European Medicines Agency’s Committee for Medicinal Products for Human Use would reconsider “the efficacy and significant overall survival benefit of Erbitux in NSCLC” demonstrated in FLEX.
Personalised treatments, 'future of cancer therapy'
In announcing the submission, Merck said it believes that "personalising treatment is the future of cancer therapy and is committed to making this a reality". Erbitux is currently indicated for EGFR-expressing metastatic colorectal cancer (mCRC)and for use in combination with radiotherapy for the treatment of locally-advanced squamous cell carcinoma of the head and neck. In July 2008, its label in Europe was expanded to include treatment of the KRAS wild-type mutation in mCRC patients.
Meantime, the German group has announced that it is setting up a fund in Israel to tap into the country's scientific expertise.
The Merck Serono Israel Bioincubator Fund is "designed to accelerate the successful development of entrepreneurial start-up companies and will offer both seed financing and the opportunity of using a dedicated part" of the company's Israeli R&D centre Interlab.
10 million euros for start-up fund
Over seven years, Merck Serono will invest a total of 10 million euros, while its chemicals unit will initiate a programme for start-ups in the area of high-tech and life science materials, worth up to 3 million euros within the next three years.
Merck chairman Karl-Ludwig Kley, on a visit to the country, said the venture "will further strengthen our research cooperations here because Israel is one of the top countries for scientific innovation and start-up companies in the fields of biopharmaceuticals and high-tech materials".