Data presented this weekend at the American Society of Clinical Oncology meeting in Orlando, USA, brought good news for Merck Serono.

The company’s novel investigational first-in-class integrin inhibitor, cilengitide, has been shown in an independent study to extend overall survival for patients with glioblastoma multiforme – an aggressive and usually rapidly fatal brain tumour that kills about 70% of patients within two years.

Results of the Phase II NABTT-0306 study, sponsored by the National Cancer Institute and run by the New Approaches to Brain Tumor Therapy (NABTT) Adult Brain Consortium, were presented in oral session. They showed cilengitide given with chemoradiotherapy (concomitant and adjuvant temozolimide with radiotherapy) extended overall survival for patients giving a median survival of 18.9 months. A year after starting treatment , 79.5% were still alive. This compares with a median survival of 14 months typically observed with chemoradiotherapy alone with about 60% alive at one year.

The 94 patients participating were treated with either a 500 or 2000mg dose of cilengitide. The higher dose showed a trend to increased survival compared to the lower dose. Burt Nabors, professor of neurology at the University of Alabama, Birmingham, USA who led the study commented: “We are encouraged by these results. Glioblastoma is a highly aggressive and challenging cancer type with very poor prognosis and we urgently need to explore new treatment options, such as cilengitide, in Phase III studies to offer real improvements in outcomes,”

Cilengitide has already been studied previously in glioblastoma multiforme in a study which found drug-related toxicity was rare. The drug is now going forward in Phase III development in the CENTRIC study, led by Roger Stupp from University of Lausanne, Switzerland, which began recruiting 500 patients from 170 centres last year.

Merck Serono announced in March this year that it was expanding its cilengitide development programme to investigate it in other indications. The drug was originally developed in house at Merck Serono’s own laboratory. In combination with the company’s flagship monoclonal antibody therapy Erbitux (cetuximab) and platinum-based chemotherapy, it will be investigated in the CERTO study as a first-line therapy for advanced non-small cell lung cancer.

It is also under investigation in the ADVANTAGE study as a treatment for squamous cell cancers of the head and neck. The drug is thought to have a dual mode of action targeting tumour cells directly but also acting as an anti-angiogenic agent.