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 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 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 Serono'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 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 programs."

About cilengitide

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. 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 Serono recently launched a large Phase III trial in advanced breast cancer - STRIDEe.

Lung cancer - burden of disease It is estimated that 1,351,000 people worldwide die from lung cancer every year5
Around 80% of lung cancer patients have NSCLC and first present with advanced disease, which is difficult to treat6,7
Only 10% of people with lung cancer are alive 5 years after diagnosis, compared to 81% for melanoma and 75% for breast cancer8
At diagnosis, most patients with NSCLC present with advanced, inoperable (also called unresectable) disease which is associated with a very poor prognosis9
Approximately 25 to 30% of cases are diagnosed as locally advanced disease (stage III) and 40 to 50% are diagnosed as metastatic disease (stage IV)10 References

1. Manegold C, et al. WCLC 2009; Abstract No: D2.2. Updated information presented at meeting.
2. Goss G, et al. WCLC 2009; Abstract No: P1.180. Updated information presented at meeting.
3. Tucker GC. Curr Oncol Rep 2006;8:96-103.
4. Carraway KL 3rd, et al. Curr Top Dev Biol 2007;78:1-22.
5. American Cancer Society. wwwncer/downloads/STT/Global_Facts_and_Figures_2007_rev2.pdf.
6. D'Addario G & Felip E. Ann Oncol 2008;19 Suppl 2:ii39-40.
7. Corner J, et al. Thorax 2005;60(4):314-9.
8. Sant M, et al. Ann Oncol 2003;14(Suppl 5):v61-118.
9. Bunn PA, et al. Oncologist 2008;13(Suppl 1):1-4.
10. Pharmalicensing. pharmalicensing/public/articles/view/1127138004_432ec2d42045f.

Source
Merck

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