STOCKHOLM, June 3, 2019 /PRNewswire/ -- Medivir AB
(Nasdaq Stockholm: MVIR) today informs that new data from the
phase I study of birinapant in combination with pembrolizumab
(Keytruda®) was presented at an oral session on June 2nd at the American Society of Clinical
Oncology (ASCO) annual meeting in Chicago, USA.
The data was presented by Dr. Russel J.
Schilder, Thomas Jefferson
University, Sidney Kimmel Cancer Center, Philadelphia, USA. The efficacy of the combination treatment
is explored in patients with different advanced solid tumors who do
not have further available treatment options.
The combination of birinapant and Keytruda® evaluated in 19
patients with advanced solid tumors was well tolerated and the
recommended dose for the phase II part of the study is the highest
tested dose birinapant 22 mg/m² and 200 mg of pembrolizumab. Two
patients achieved a partial response and seven patients achieved
stable disease as best response. Two patients are still on
treatment, one patient with MSS colorectal cancer has been treated
for 80 weeks and has achieved a partial response; and one patient
with osteosarcoma is in stable disease has been treated for 24
weeks.
"We are delighted to see these encouraging long-term data from
the phase l study of birinapant in combination with Keytruda® in a
patient population, who does not have further available treatment
options. The long-term data do not indicate any safety concerns
related to the combination therapy," said Uli Hacksell, PhD., CEO
of Medivir.
The study is conducted in collaboration with Merck, who provides
Keytruda®. Further information on the study can be found at
clinicaltrials.gov with the reference number NCT02587962
For further information, please contact:
Uli Hacksell, CEO, Medivir AB, phone: +46(0)73-125-0615
About birinapant
Birinapant is being developed to enhance responses, and extend
survival, of patients with solid tumors where existing treatments
do not provide sufficient survival benefit, or where patients no
longer have treatment options. Based on its unique design and
mechanism, birinapant has the potential to enhance patients'
responses in combination with other treatments. Medivir's initial
focus is on developing birinapant in combination with an
immuno-oncology agent.
About the birinapant/Keytruda® combination study
The multi-center, single arm, open label study, which is
primarily being run in the US, is being conducted in two parts. In
the initial dose escalation (phase I) part of the study, the
objective was to identify the recommended phase II dose of
birinapant for use in combination with Keytruda® by administering
increasing doses of birinapant in combination with the approved
dose of Keytruda® to groups of up to 6 patients with treatment
refractory solid tumors.
The primary objective of the ongoing phase II part is to
evaluate the efficacy of birinapant in combination with Keytruda®
in colorectal cancer patients. An important secondary objective in
the phase II part is to further assess safety and tolerability of
the combination.
About Medivir
Medivir develops innovative drugs with a focus on cancer where
the unmet medical needs are high. The company is investing in
indication areas where available therapies are limited or missing
and there are great opportunities to offer significant improvements
to patients. Collaborations and partnerships are important parts of
Medivir's business model and the drug development as well as the
commercialization is conducted either by Medivir or in partnership.
Medivir's share (ticker: MVIR) is listed on Nasdaq Stockholm's
Small Cap list. http://www.medivir.com/.
This information was brought to you by Cision
http://news.cision.com
https://news.cision.com/medivir/r/new-data-from-the-phase-i-study-of-birinapant-in-combination-with-keytruda--presented-at-asco,c2830642
The following files are available for download:
|
https://mb.cision.com/Main/652/2830642/1055917.pdf
|
Press release
(PDF)
|
View original
content:http://www.prnewswire.com/news-releases/new-data-from-the-phase-i-study-of-birinapant-in-combination-with-keytruda-presented-at-asco-300860415.html
SOURCE Medivir
