· Results reported from a randomized Phase II study of cilengitide in 2nd-line monotherapy for stage IV NSCLC
(HealthNewsDigest.com) – San Francisco, CA, USA/Darmstadt, Germany, – A randomized Phase II study presented today 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).1 The data support the clinical program 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 6 months versus 6.4 months for docetaxel and 1-year survival rate of 29% versus 27% for docetaxel.1 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% of the patients treated with cilengitide and 41% of the patients treated with docetaxel.1 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 KGaA’s second late-stage pipeline product, Stimuvax® (BLP25 liposome vaccine).2 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 KGaA. “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 programs.”
About cilengitide
The integrin inhibitor cilengitide, developed in Merck KGaA’s own laboratories, is the first in this new class of investigational anti-cancer therapies to reach Phase III development. Integrin inhibitors target integrins – specific cell surface receptors that are improperly regulated in many tumor types and thereby involved in cancer growth. Cilengitide is thought to work by targeting tumor cells directly and by preventing the formation of new blood vessels to the tumor, a process known as angiogenesis.3 Cilengitide is also being investigated in a range of different indications including the Phase III study CENTRICc in glioblastoma and the Phase II study ADVANTAGEd in head and neck cancer.
About Stimuvax
Stimuvax is thought to work by priming the body’s own immune system to identify and target cancer cells directly. Stimuvax targets the antigen MUC1, which is over-expressed on the surface of several tumor types and which plays multiple roles in promoting tumor growth and survival.4,5 Stimuvax is currently being evaluated in a range of different cancer types, and Merck KGaA recently launched a large Phase III trial in advanced breast cancer – STRIDEe.
For more information on studies with either cilengitide or Stimuvax log on to www.clinicaltrials.gov.
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