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Published on 17 December 2009

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Boehringer Ingelheim initiates first phase III clinical trial in ovarian cancer

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Boehringer Ingelheim announced today the initiation of a new phase IIIclinical trial to evaluate one of its two late-stage oncology pipelinecompounds for the treatment of patients with advanced ovarian cancer.The clinical study, called LUME-Ovar-1 trial, investigates the compoundBIBF 1120, a novel oral anti-angiogenic agent, for its efficacy and safety as first-linetreatment in combination with standard chemotherapy compared to placeboin combination with standard chemotherapy in patients with advancedovarian cancer.

The LUME–Ovar 1 trial / AGO-OVAR 12
AGO-OVAR 12or LUME-Ovar 1 is an intergroup study conducted by an internationalconsortium of study groups led by the AGO Study Group(Arbeitsgemeinschaft Gynaekologische Onkologie Study Group, Germany),and Boehringer Ingelheim. BIBF 1120 (planned brand name Vargatef) is anovel oral compound that works by simultaneously inhibiting threereceptors involved in the formation of blood vessels, a process alsocalled angiogenesis, which is needed for tumours to grow and spread.

“Anti-angiogenic compounds are one of the most promising newapproaches in treating cancer, and ovarian cancer appears to beparticularly sensitive to these novel agents, as suggested by earlyclinical trials.” said Andreas du Bois, MD, PhD, of AGO Study group andInternational Coordinating Investigator of this trial. “BIBF 1120inhibits several aspects of the pathway that controls the growth of newblood vessels, and it has already been shown to be both effective andwell tolerated in previous trials, including a recently completed phaseII trial of BIBF 1120 in ovarian cancer.”

The AGO Study group has already performed a phase I/II study anddeveloped the combination now evaluated. “Based on our good experiencewith this combination,” said Dr. Philipp Harter MD , of AGO study groupand principal investigator of the starting trial, “we look forward tocontinue investigating this novel compound in ovarian cancer patientsin the first line setting.”

The decision to progress BIBF 1120 into a phase III trial in ovariancancer was based on previous study results which indicate that theagent may be both efficacious and well tolerated as maintenance therapyin patients with relapsed ovarian cancer who had responded to priorchemotherapy. Data presented this year at the annual meeting of theAmerican Society of Clinical Oncology (ASCO) showed that in the trialwomen with ovarian cancer treated with BIBF 1120 were less likely toexperience progression of their disease compared to those treated withplacebo: at 36 weeks, 14.3% of women taking BIBF 1120 wereprogression-free compared to 5% of women taking placebo. 1 This phase II trial represents the firstpublished randomised, placebo controlled data of an anti-angiogenicagent in ovarian cancer.

As angiogenesis plays a pivotal role in the growth of all solidtumours, BIBF 1120 is currently being investigated in a number ofcancers including advanced non-small cell lung cancer (NSCLC),colorectal cancer (CRC), renal cell cancer (RCC) und hepatic cellcancer (HCC).

BIBF 1120 is one of Boehringer Ingelheim’s most advanced compoundsalong with BIBW 2992 (planned trade name Tovok™), both of which arecurrently in phase III development for the treatment of patients withadvanced non-small cell lung cancer, a patient population with limitedtreatment choices.

LUX-Lung 1 Trial: Development progress with BIBW 2992
Inthe clinical development of the compound BIBW 2992, a milestone hasbeen reached recently. The company completed patient recruitment for aPhase III Lung cancer trial, the LUX-Lung 1 trial. LUX-Lung 1investigates BIBW 2992 (planned brand name Tovok™) plus best supportivecare (BSC) versus placebo plus BSC in non-small cell lung cancerpatients who have experienced a failure of treatment with erlotinib orgefitinib (EGFR TKI failures).

Boehringer Ingelheim believes in evidence-based, scientificprogress; its extensive oncology clinical trial programme involves morethan 800 study centers in 47 countries. Boehringer Ingelheim has adedicated cancer research center in Vienna where scientists are focusedon the discovery and development of new treatments to combat oralleviate cancer.

Boehringer Ingelheim

 



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