Sobi North America, the North American affiliate of Swedish Orphan
Biovitrum AB (Sobi®), today announced the presentation of three
abstracts that highlights data from its myelofibrosis treatment
option at the American Society of Clinical Oncology (ASCO) Annual
Meeting taking place in Chicago from May 31 – June 4, 2024.
Sobi’s commitment to delivering innovative treatments for people
living with hematological diseases is seen in global studies
spanning multiple rare disorders, including myelofibrosis.
A retrospective analysis will be presented that demonstrates the
efficacy of pacritinib in spleen volume reduction, symptom benefit
and red blood cell transfusion response, compared with best
available therapy, in patients with myelofibrosis who have both
thrombocytopenia and anemia.
An additional retrospective analysis will be presented that
shows the substantial symptom benefit pacritinib provides compared
with best available therapy or low-dose ruxolitinib, specifically
in patients who required red blood cell transfusion at the time of
pacritinib initiation. The number of patients experiencing
treatment emergent Grade 3 anaemia was similar between pacritinib
and BAT groups.
New real-world data will be presented that demonstrates
treatment with pacritinib provides stability or improvement in
thrombocytopenia and/or anemia in patients with myelofibrosis,
regardless of baseline counts, and has favorable overall survival
similar to other JAK inhibitor historical controls.
Key Sobi data to be presented at ASCO 2024
Myelofibrosis |
Vonjo(pacritinib) |
Impact of pacritinib on symptoms in patients with thrombocytopenia
and myelofibrosis who require red blood cell transfusion |
Poster presentation #6577Monday, 3 June, 2024; 9:00 - 12:00
CDT |
Efficacy of pacritinib in patients with myelofibrosis who have both
thrombocytopenia and anemia |
Poster presentation #6578Monday, 3 June, 2024; 9:00 - 12:00
CDT |
Real-world treatment patterns and outcomes in patients with
myelofibrosis treated with pacritinib in the United States |
Poster presentation #6579Monday, 3 June, 2024; 9:00 - 12:00
CDT |
All abstracts can be accessed via the official ASCO website.
ContactsFor details on how to contact the Sobi
Investor Relations Team, please click here. For Sobi Media, click
here.
About Vonjo®VONJO is approved for the treatment
of adults with intermediate- or high-risk primary or secondary
(post-polycythemia vera or post-essential thrombocythemia)
myelofibrosis with a platelet count below 50 × 109/L. This
indication is approved under FDA accelerated approval based on
spleen volume reduction. Continued approval for this indication may
be contingent upon verification and description of clinical benefit
in a confirmatory trial(s). Sobi is conducting the Phase 3 PACIFICA
study of VONJO in patients with myelofibrosis and severe
thrombocytopenia as a post-marketing requirement.
Vonjo Indication and Important Safety
InformationVONJO is a prescription medicine used to treat
adults with certain types of myelofibrosis (MF) who have a platelet
count below 50,000 per microliter. This indication is approved
under accelerated approval based on spleen volume reduction.
Continued approval for this indication may depend on proof and
description of clinical benefit in a confirmatory trial(s).
It is not known if VONJO is safe and works in children.
Important Safety Information
What are the serious side effects of VONJO?
Bleeding. VONJO may cause severe bleeding,
which can be serious and, in some cases, may lead to death. Do not
take VONJO if you are bleeding. If you start bleeding, stop VONJO
and call your healthcare provider. Your healthcare provider will do
a blood test to check your blood cell counts before you start VONJO
and regularly during your treatment with VONJO. Tell your
healthcare provider right away if you develop any of these
symptoms: unusual bleeding, bruising, and fever. You will
need to stop taking VONJO 7 days before any planned surgery or
invasive procedures (such as a heart catheterization, stent
placement in a coronary artery in your heart, or a procedure for
varicose veins). Your healthcare provider should tell you when you
can start taking VONJO again.
Diarrhea. Diarrhea is common with VONJO, but
can be severe, and cause loss of too much body fluid (dehydration).
Tell your healthcare provider if you have diarrhea and follow
instructions for what to do to help treat diarrhea. If you notice
any change in how often you have bowel movements, if they become
softer or you have diarrhea, your health care provider may tell you
to start taking an antidiarrheal medicine as soon as you notice
changes.
Worsening low platelet counts. Your healthcare
provider will do blood tests to check your blood counts before you
start taking VONJO and during treatment with VONJO.
Changes in the electrical activity of your heart called
QTc prolongation. QTc prolongation can cause irregular
heartbeats that can be life-threatening. Your healthcare provider
will check the electrical activity of your heart before you start
and during treatment with VONJO, as needed. If you have a history
of low blood potassium, it is important that you get your blood
tests done as ordered by your healthcare provider to monitor
electrolytes in your blood. Tell your healthcare provider
right away if you feel dizzy, lightheaded, faint or feel
palpitations.
Increased risk of major cardiovascular events such as
heart attack, stroke, or death in people who have cardiovascular
risk factors and who are current or past smokers have
happened in some people taking another Janus associated kinase
(JAK) inhibitor to treat rheumatoid arthritis. Get
emergency help right away if you have any symptoms of a heart
attack or stroke while taking VONJO, including: discomfort
in the center of your chest that lasts for more than a few minutes,
or that goes away and comes back; severe tightness, pain, pressure,
or heaviness in your chest, throat, neck, or jaw; pain or
discomfort in your arms, back, neck, jaw, or stomach; shortness of
breath with or without chest discomfort; breaking out in a cold
sweat; nausea or vomiting; feeling lightheaded; weakness in one
part or on one side of your body; or slurred speech.
Increased risk of blood clots. Blood clots in
the veins of your legs (deep vein thrombosis) or lungs (pulmonary
embolism) have happened in some people taking another JAK inhibitor
and may be life-threatening. Tell your healthcare provider if you
have had blood clots in the veins of your legs or lungs in the
past. Tell your healthcare provider right away if you have
any signs and symptoms of blood clots during treatment with
VONJO, including: swelling, pain, or tenderness in one or
both legs; sudden, unexplained chest pain; or shortness of
breath/difficulty breathing.
Possible increased risk of new (secondary)
cancers. People who take another JAK inhibitor for
rheumatoid arthritis have an increased risk of new (secondary)
cancers, including lymphoma and other cancers. The risk of new
cancers is greater if you smoke or have smoked in the past.
Risk of infection. People who have certain
blood cancers and take another JAK inhibitor have an increased risk
of serious infections. People who take VONJO may develop serious
infections, including bacterial, mycobacterial, fungal, and viral
infections. If you have a serious infection, your healthcare
provider may not start you on VONJO until your infection is
treated. Tell your healthcare provider right away if you
develop any of the following symptoms of infection:
chills, aches, fever, nausea, vomiting, weakness, painful skin
rash, or blisters.
What should I tell my healthcare provider before
starting VONJO?
- Current or past smoking history
- Previous medical conditions such as any other cancers, blood
clot, heart attack, other heart problems, stroke, infection,
diarrhea, commonly loose stools, nausea, vomiting, liver problems,
or kidney problems
- Have active bleeding, have had severe bleeding or plan to have
surgery. You should stop taking VONJO 7 days before any planned
surgery or invasive procedures because you may be at higher risk
for bleeding
- Are pregnant, plan to become pregnant, are breastfeeding, or
plan to breastfeed. It is not known if VONJO will harm your unborn
baby or if it passes into breast milk. You should not breastfeed
during treatment and for 2 weeks after your last dose of VONJO
- Plan to father a child. VONJO may affect fertility in males.
You may have problems fathering a child
Tell your healthcare provider about all the medicines
you take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements and remedies.
What are the most common side effects with
VONJO?Nausea, vomiting, low red blood cell count (anemia),
and swelling of your ankles, legs, and feet. These are not all the
possible side effects of VONJO.
If you suspect that you have experienced a side effect, call
your healthcare provider. You may also report side effects to the
US Food and Drug Administration (FDA) at 1-800-FDA-1088.
Please see the full Prescribing
Information for VONJO.
About Sobi North AmericaAs the
North American affiliate of international biopharmaceutical company
Sobi, the Sobi North America team is committed to Sobi’s vision of
being a leader in providing innovative treatments that transform
lives for individuals with rare diseases. Our product portfolio
includes multiple approved treatments focused on immunology,
hematology and specialty care. With U.S. headquarters in the Boston
area, Canadian headquarters in the Toronto area, and field sales,
medical and market access representatives spanning North America,
our growing team has a proven track record of commercial
excellence. More information is available at
https://www.sobi.com/usa or at www.sobi.com.
About Sobi®Sobi is a specialized international
biopharmaceutical company transforming the lives of people with
rare and debilitating diseases. Providing reliable access to
innovative medicines in the areas of hematology, immunology and
specialty care, Sobi has approximately 1,800 employees across
Europe, North America, the Middle East, Asia and Australia. In
2023, revenue amounted to SEK 22.1 billion. Sobi’s share (STO:SOBI)
is listed on Nasdaq Stockholm. More about Sobi at sobi.com,
LinkedIn and YouTube.