A randomized phase-II study presented at the International Association for the Study of Lung Cancer's 13th World Conference of Lung Cancer (WCLC) compared the integrin inhibitor cilengitide and docetaxel in 2nd-line therapy for patients with stage IV non-small cell lung cancer (NSCLC). The data support the clinical programme of Merck Serono, a division of Merck KGaA, Darmstadt, Germany, for the ongoing development of cilengitide in NSCLC.
The study investigated the efficacy and safety of three dose regimens of cilengitide versus docetaxel. Cilengitide monotherapy at the highest dose of 600 mg/m2 showed overall survival of six months versus 6.4 months for docetaxel and 1-year survival rate of 29 per cent versus 27 per cent for docetaxel. Median progression-free survival of patients receiving cilengitide in each of the 400 and 600 mg/m2 doses was 2.1 months versus 2.2 months in patients receiving docetaxel (75 mg/m2). Grade 3/4 treatment-related adverse events were observed in 10.5 per cent of the patients treated with cilengitide and 41 per cent of the patients treated with docetaxel. Docetaxel chemotherapy is considered a standard 2nd-line therapy for patients with stage IV NSCLC.
"Patients who have stage IV NSCLC and whose 1st-line therapy was unsuccessful have very few therapeutic options. The phase-II comparative results suggest that, after further evaluation, cilengitide may have an important role in the treatment of NSCLC," said the principal investigator of the study, professor Christian Manegold from the Heidelberg University Medical Center, Mannheim, Germany.
Another randomized, multicenter phase-II study - CERTOa - is currently investigating two cilengitide regimens in combination with Erbitux (cetuximab) and platinum-based chemotherapy (cisplatin/vinorelbine or cisplatin/gemcitabine) compared to cetuximab and platinum-based chemotherapy alone as a 1st-line treatment for patients with advanced NSCLC.
Further data in NSCLC was also presented from Merck Serono's second late-stage pipeline product, Stimuvax (BLP25 liposome vaccine). Updated long-term safety data from a randomized phase-IIb study of 16 patients with advanced NSCLC have shown that the most common treatment-related adverse events observed in patients treated from 2 to 8.2 years were mild injection-site reactions and nausea. These data support current investigation in the phase-III clinical study STARTb.
"We are very excited about the potential of our late-stage pipeline products, cilengitide and Stimuvax," said Dr Wolfgang Wein, executive vice president, Oncology, Merck Serono. "We are particularly pleased with both sets of results in this challenging NSCLC setting, which is a positive indicator for the future of the clinical development programmes."
The integrin inhibitor cilengitide, developed in Merck Serono's own laboratories, is the first in this new class of investigational anti-cancer therapies to reach phase-III development.
Stimuvax is thought to work by priming the body's own immune system to identify and target cancer cells directly.
Cilengitide is currently being developed by Merck KGaA. Cilengitide is the first in a new class of investigational anti-cancer therapies called integrin inhibitors in phase-III of development; it is currently being investigated for the treatment of glioblastoma, SCCHN and NSCLC.
Merck is investigating the use of Stimuvax (BLP25 Liposome Vaccine) in the treatment of NSCLC.