Boehringer’s ovarian cancer drug enters phase III
pharmafile | December 18, 2009 | News story | Research and Development, Sales and Marketing | Boehringer, Cancer, ovarian
Boehringer Ingelheim has started a new phase III trial for its investigational cancer drug BIBF 1120.
The LUME-Ovar-1 programme will look at the compound’s efficacy and safety versus placebo as a first-line treatment in combination with standard chemotherapy for patients with advanced ovarian cancer.
BIBF 1120, which the company hopes to market under the brand name Vargatef, is a novel oral anti-angiogenic agent.
It blocks angiogenesis, the process of forming the vessels that supply tumours with nutrients to enable them to grow and spread, by simultaneously inhibiting three receptors.
Ovarian cancer, often called the “silent killer”, is frequently undetected until a late stage and is the sixth most common cancer in women, according to the World Health Organisation.
Around 125,000 women died from the disease in 2002.
“Anti-angiogenic compounds are one of the most promising new approaches in treating cancer,” said Andreas du Bois, of the German AGO (Arbeitsgemeinschaft Gynaekologische Onkologie) study group, who is the trial’s international co-ordinating investigator.
“BIBF 1120 inhibits several aspects of the pathway that controls the growth of new blood vessels, and it has already been shown to be both effective and well-tolerated in previous trials.”
The combination of BIBF 1120 and standard chemotherapy now being evaluated was developed in AGO’s phase I/II study, which showed it might be successful as maintenance therapy in patients with relapsed ovarian cancer who had responded to prior chemotherapy.
The annual meeting of the American Society of Clinical Oncology this year heard data that patients were less likely to experience progression of their disease compared to placebo.
At 36 weeks, 14.3% of women taking BIBF 1120 were progression-free compared to 5% of women taking placebo.
It is estimated that only 45% of US women with ovarian cancer are still alive five years after diagnosis.
Angiogenesis plays a key role in the growth of all solid tumours, so BIBF 1120 is also being investigated in advanced non-small cell lung, colorectal, renal cell and hepatic cell cancers.
Boehringer Ingelheim has also enrolled patients for a phase III study in lung cancer with another advanced compound, called BIBW 2992 (whose planned trade name is Tovok).
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