Boehringer blood cancer drug scores in Phase II
pharmafile | July 9, 2014 | News story | Research and Development, Sales and Marketing | Boehringer, blood, giotrif, leukaemia, volasertib
Less than a year after securing its first cancer drug on the market with Giotrif, Boehringer has taken another decisive step toward its oncology drive with new study results for volasertib.
Data from a Phase II study published this week in the journal Blood, showed patients with previously untreated acute myeloid leukaemia (AML) aged 65 or older and ineligible for intensive remission induction therapy, lived longer when treated with volasertib combined with low dose cytarabine (LDAC), a form of chemotherapy, compared to LDAC alone.
The overall survival data also showed that volasertib, when used in combination with LDAC, increased the percentage of older AML patients who achieved remission.
Professor Döhner from the Department of Internal Medicine III of the University Hospital Ulm, and principal investigator of the Phase II trial, says: “Despite being a rare disease, AML is one of the most common leukaemias in adults and predominantly affects older people.
“The established approach to treat younger AML patients is an intensive chemotherapy regimen, called intensive induction therapy. However, older patients often cannot tolerate these chemotherapy doses, and have very limited treatment options.”
Döhner continues: “These clinical trial results that evaluated volasertib in combination with a lower intensity chemotherapy are important and have informed future research for this rare disease, where new treatment options are greatly needed.”
The Phase II clinical trial showed patients treated with volasertib combined with LDAC had a median overall survival of 8 months versus 5.2 months in patients treated with LDAC alone.
The response rate (complete remission or complete remission with incomplete blood count recovery) was more than doubled for patients receiving volasertib and LDAC versus LDAC alone (31% versus 13.3 per cent).
Volasertib has not yet received any form of approval and is an investigational compound that inhibits enzymes called Polo-like kinases (Plks).
Inhibition of Plk1 by ultimately results in cell death (apoptosis) and by inhibiting Plk1 activity, the extremely high cell division that is characteristic of AML should be blocked, which may result in cancer regression.
“As with other rare and life threatening diseases, the need for new treatment options in AML is very high. Boehringer Ingelheim is committed to research in areas of unmet medical need, including those in rare diseases,” explains Professor Klaus Dugi, chief medical officer at Boehringer.
“We are pleased to see that volasertib has shown promising overall survival results in this clinical trial and we are optimistic that the drug will further demonstrate its potential benefit in this rare disease in the ongoing Phase III study.”
The drug was awarded a ‘Breakthrough Therapy Designation’ by the FDA in 2013, as well as an orphan drug designation by both the US regulator and the European Commission in 2014.
It is currently being investigated in combination with LDAC in a Phase III clinical trial for AML called POLO-AML-2.
The privately-owned German firm is hoping this can soon be added to its lung cancer drug Giotrif – the company’s first oncology product approved last year – as it looks to build up its cancer offering.
Competition
If approved however, the drug will be competing with a number of established medicines for AML, including Celgene’s Vidaza (azacitidine) and Janssen’s Dacogen (decitabine).
There are also new drugs also in development, including Sunesis’ vosaroxin, Novartis’ PKC412 (midostaurin) and Cycacel’s sapacitabine.
But despite the crowded marketplace this can be a lucrative area for those firms involved, as British analysts at GlobalData expect the AML market to generate revenues of $430 million by 2017 – nearly three times its current value.
Leukaemia is a rare cancer of the bone marrow and blood, and AML is one of the most common types of leukaemia in adults, accounting for around one-third of all adult leukaemias in the Western world.
AML has one of the lowest survival rates of all leukaemias and predominantly occurs in older adults, with the average age of newly diagnosed patients at 65 years old.
Ben Adams
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