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June 5, 2010, 8:20 a.m. EDT · Recommend · Post:
Cilengitide Study Provides Long-Term Follow-up Data in Glioblastoma Patients Receiving Investigational Drug for More Than 4 Years
No treatment-related severe adverse events were observed during long-term treatment in a randomized Phase II study
CHICAGO & DARMSTADT, Germany, Jun 05, 2010 (BUSINESS WIRE) -- ASCO Abstract Numbers: 2010, TPS151, TPS152
Merck Serono, a division of Merck KGaA, Darmstadt, Germany announced today that long-term follow-up data of a randomized Phase II study of two cilengitide doses in recurrent glioblastoma were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The data showed that treatment of 15 patients with the investigational integrin-inhibitor for more than six months and for up to 4.5 years did not result in any treatment-related severe adverse events (Grade 3/4). In addition, 37% of patients who received the higher dose of cilengitide (2000 mg) were still alive after one year and 22% after two years.(1) The current prognosis of patients with recurrent glioblastoma is poor with median overall survival (OS) between 4-7 months and one year survival rates of approximately 20%.(2,3)
Treatment-related adverse events (AEs) usually occurred within the first six months of receiving cilengitide and the most common (>1 patient) was fatigue (n=3). The most common non-treatment-related grade 3/4 serious AE was convulsion (n=2).
"The prognosis for patients with recurrent glioblastoma is extremely poor and additional treatment options have been desperately needed for some time," said Dr. Karen Fink, Baylor University Medical Center, Dallas. "We are excited about the results of this study, in that patients were able to receive cilengitide beyond six months with no treatment-related severe adverse events. Moreover, 10% of patients were still alive after four years."
The randomized Phase II study also supports the Phase I study finding of activity with cilengitide monotherapy(4) and indicates that cilengitide efficacy is dose-dependent with OS and long-term survival rates consistently higher for the 2,000 mg treatment group compared to the 500 mg group during more than four years of follow-up:
-- The one-, two-, and four-year survival rates for patients treated with twice-weekly 2,000 mg cilengitide compared to twice-weekly 500 mg cilengitide were 37% vs. 22%, 22% vs. 12%, and 10% vs. 2%, respectively(1)
-- In the original Phase II study publication, cilengitide efficacy was dose-dependent with the median OS higher with twice weekly 2,000 mg than with twice weekly 500 mg.(5) Median OS was 9.9 months vs. 6.5 months in the high- and low-dose cilengitide groups, respectively(5)
"These positive long-term data once again support our ongoing Phase III study program of cilengitide in patients with this devastating disease. We believe that cilengitide may play a valuable part in the future care of glioblastoma patients," said
Dr. Wolfgang Wein, Executive Vice President, Oncology, Merck Serono.
Developed in Merck Serono's own laboratories, cilengitide is the first in the new class of anti-cancer therapies called integrin inhibitors to reach Phase III of development.* A pivotal Phase III trial -- CENTRICa -- is underway in patients with newly diagnosed glioblastoma. The study design of CENTRIC will be presented at this year's ASCO meeting.(6)Also presented at the annual meeting will be CENTRIC's Phase II companion trial investigating cilengitide in glioblastoma (COREb).(7) Other randomized cilengitide trials are currently underway in non-small cell lung cancer (CERTOc) and squamous cell carcinoma of the head and neck (ADVANTAGE d).
The ongoing clinical development program for cilengitide is part of Merck Serono's oncology portfolio that may provide novel treatment options, and therefore new hope, for patients with aggressive cancers, such as non-small cell lung cancer, head and neck cancer and glioblastoma. As such, Merck Serono continues to invest in research to uncover potentially innovative treatments to further change the landscape of cancer management.
About Cilengitide
Cilengitide, an investigational avB3 and avB5 integrin inhibitor, has been shown to have anti-angiogenic and direct anti-tumor effects in laboratory studies.(8-9) Integrins have been demonstrated to play a role in cancer progression, specifically in tumor cell survival, tumor angiogenesis, and metastasis.(8-9)
* Cilengitide has not been approved for commercial distribution