Download Boehringer Ingelheim`s volasertib showed in a Phase II

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09-Jul-2014 9:45 AM
Topic: Health
Boehringer Ingelheim's volasertib showed in a Phase
II study an improvement in overall survival in older
AML patients
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In older, untreated AML patients not suitable for intensive chemotherapy, volasertib* combined with
chemotherapy led to prolonged survival times compared to chemotherapy alone
Volasertib* also more than doubled remission rates
AML is a rare type of aggressive cancer of the bone marrow and blood predominantly affecting adults over
60
INGELHEIM, Germany--(BUSINESS WIRE)--For media outside of the US/UK only
“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.”
Summary:
Acute Myeloid Leukaemia (AML) is an aggressive and devastating blood cancer. 1,2 It predominantly affects people
over 60 and is one of the most common adult leukaemias in the Western World. 1 The current standard of care is
intensive chemotherapy, but many older patients cannot tolerate this therapeutic approach; their options are limited
and their prognosis is poor. For older AML patients not suitable for intensive chemotherapy, low dose cytarabine
(LDAC) is a well-established form of chemotherapy. Volasertib*, currently being developed by Boehringer Ingelheim,
showed in recent studies to be a potentially promising alternative treatment for these patients. In this Phase II
clinical trial volasertib*, combined with LDAC, led to prolonged survival times and more than doubled the percentage
of patients achieving remission compared to LDAC alone. Volasertib* is currently being investigated in combination
with LDAC in a Phase III clinical trial.
Results from a Phase II study, published today in the American Society of Hematology journal Blood,3 showed
patients with previously untreated acute myeloid leukemia (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 showed that volasertib*, when used in
combination with LDAC, increased the percentage of older AML patients who achieved remission.
“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,” commented Prof. Döhner from the Department of Internal Medicine III of the University
Hospital Ulm and principal investigator of the Phase II trial. “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%).
Volasertib* is an investigational compound that inhibits enzymes called Polo-like kinases (Plks). Plk1 is the best
characterized kinase of the Plk family. Inhibition of Plk1 by volasertib* ultimately results in cell death (apoptosis).4 By
inhibiting Plk1 activity, the extremely high cell division that is characteristic of AML should be blocked, which may
result in cancer regression.
The most common non-haematological adverse events for patients receiving the combination treatment were
decreased white blood cells with fever and infections and gastrointestinal side effects. These side effects were
clinically manageable and were expected given the mechanism of action of volasertib*. 3,5
“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.” commented
Prof. Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. “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.”
Volasertib* was awarded Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) in
2013 and Orphan Drug Designation by the FDA and the European Commission in 2014. It is currently being
investigated in combination with LDAC in a randomised, double-blind, multi-centre, controlled Phase III clinical trial
for AML called POLO-AML-2.
*Volasertib is an investigational compound and is not yet approved. Its safety and efficacy have not yet been fully
established.
~ENDS~
Please click on the link below for 'Notes to Editors' and 'References':
http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2014/08_july_2014_oncology.html
Contacts
Boehringer Ingelheim
Corporate Communications
Media + PR
Dr. Julia Knebel
Phone: +49 6132 – 77 95614
Fax: +49 6132 – 77 6601
Email: [email protected]
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