- Early and confirmed anti-tumor activity, 16 of 20 patients
with disease control at first scan and sustained tumor control for
13 of 18 patients with >3 months follow-up
- Durable clinical benefit, median time to progression (to
date) ~4.5 months with >50% of patients still on
treatment
- Consistently good safety and tolerability profile
STOCKHOLM, Oct. 5, 2023
/PRNewswire/ -- Medivir AB (Nasdaq:MVIR) (Stockholm:
MVIR), a pharmaceutical company focused on developing innovative
treatments for cancer in areas of high unmet medical need,
announced today that all patients in the ongoing phase 2a study in
advanced hepatocellular carcinoma (HCC) has now dosed at least two
treatment cycles and the treatment continues to show very promising
clinical benefit. The study evaluates safety and efficacy with the
candidate drug fostrox in combination with Lenvima® in patients for
whom current first- or second-line treatment has proven ineffective
or is not tolerable.
The study, which is an open-label, multi-center, dose-escalation
and dose-expansion study, continues to show early and durable
clinical benefit across the cohort, as measured by local review. Of
the 13 patients with sustained tumor control at 3 months, 3
patients achieved Partial Response and 10 patients Stable Disease,
providing 17% Overall Response Rate (ORR) and 72% Disease Control
Rate (DCR). The patient who has benefited the longest remains on
treatment after 13.5 months, with sustained partial response.
The combination remains tolerable with no unexpected new safety
events and adverse events are transient and manageable. Continued
lower need for dose reductions or interruptions than expected. The
observed tolerability is of outmost importance as patients with HCC
often have an increased sensitivity to drugs in general due to
impaired liver function.
"Overall, the consistent early and durable signals of clinical
benefit and the favorable safety profile are very encouraging.
Patients with advanced HCC, who have progressed on at least
one line of treatment, are a very difficult-to-treat population
with few effective treatment options. The overall response rate of
17% already at 2nd scan is very encouraging and
indicates a higher share of responders than historically seen in
second line treatment of HCC. We can also see that for many
patients, their target lesions continue to shrink with longer
follow-up," says Dr. Pia Baumann,
CMO at Medivir.
Medivir plans to provide an update in connection with the
company's upcoming quarterly results presentation on Friday October 27. This will include a more
comprehensive update of local review data as most of the patients
will have had the opportunity to have at least three scans, with
each scan scheduled to take place every 6 weeks. In addition to the
data update, the company will also provide further context what
these more mature data could mean for future clinical practice in
second line HCC, a patient population for whom there are no
approved medical treatments today.
For additional information, please contact;
Magnus Christensen, CFO, Medivir
AB
Telephone: +46 8 5468 3100
E-mail: magnus.christensen@medivir.com
About fostrox
Fostrox is an oral pro-drug, designed to selectively treat liver
cancers and to minimize side effects. It has the potential to
become the first liver-targeted and orally administered drug for
patients with HCC. Fostrox has completed a phase 1b monotherapy study, and a combination study in
HCC currently ongoing.
About primary liver cancer
Primary liver cancer is the third leading cause of
cancer-related deaths worldwide and hepatocellular carcinoma
(HCC) is the most common cancer that arises in the liver. Although
existing therapies for advanced HCC can extend the lives of
patients, treatment benefits are insufficient and death rates
remain high. There are approximately 660,000 patients diagnosed
with primary liver cancer per year globally and current five-year
survival is less than 20 percent1). HCC is a
heterogeneous disease with diverse etiologies, and lacks defining
mutations observed in many other cancers. This has contributed to
the lack of success of molecularly targeted agents in HCC. The
limited overall benefit, taken together with the poor overall
prognosis for patients with intermediate and advanced HCC, results
in a large unmet medical need.
About Medivir
Medivir develops innovative drugs with a focus on cancer where
the unmet medical needs are high. The drug candidates are directed
toward indication areas where available therapies are limited or
missing and there are great opportunities to offer significant
improvements to patients. Medivir is focusing on the development of
fostroxacitabine bralpamide (fostrox), a pro-drug designed to
selectively treat liver cancer and to minimize side effects.
Collaborations and partnerships are important parts of Medivir's
business model, and the drug development is conducted either by
Medivir or in partnership. Birinapant, a SMAC mimetic, is
exclusively outlicensed to IGM Biosciences (Nasdaq: IGMS) to be
developed in combination with IGM-antibodies for the treatment of
solid tumors. Medivir's share (ticker: MVIR) is listed on Nasdaq
Stockholm's Small Cap list. www.medivir.com.
1) Rumgay et al.,European Journal of Cancer 2022 vol.161,
108-118.
The following files are available for download:
https://mb.cision.com/Main/652/3848542/2341511.pdf
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