Overall survival and additional long-term
follow-up data from the Phase 2b
HERIZON-BTC-01 trial in previously treated HER2-positive metastatic
biliary tract cancer (BTC) to be presented at ASCO 2024
DUBLIN, April 24,
2024 /PRNewswire/ -- Jazz Pharmaceuticals
plc (Nasdaq: JAZZ) today announced that the company, along
with its partners, will present or publish eight abstracts at
the American Society of Clinical Oncology (ASCO) Annual Meeting
from May 31-June 4, 2024 in
Chicago. Presentations include
data from trials of zanidatamab, Zepzelca®
(lurbinectedin), and Rylaze® (asparaginase erwinia
chrysanthemi (recombinant)-rywn). A poster featuring the study
design for the JZP898 Phase 1 trial in progress will also be
presented.
Updated data with longer follow-up, including overall survival
findings, will be presented from the Phase 2b HERIZON-BTC-01 trial of zanidatamab, a
HER2-targeted bispecific, biparatopic antibody, in previously
treated HER2-positive biliary tract cancer (BTC). Data from the
HERIZON-BTC-01 trial were the backbone of the recently completed
Biologics License Application (BLA) submission for previously
treated HER2-positive metastatic BTC.
"We are excited to present data across our oncology pipeline and
portfolio at ASCO, particularly the opportunity to provide updated
data from the pivotal Phase 2b
HERIZON-BTC-01 trial of zanidatamab in HER2-positive BTC presented
at last year's meeting. BTC is often associated with a poor
prognosis, and we believe zanidatamab has the potential to be
transformative to the current standard of care in BTC and multiple
HER2-expressing cancers, including in cases resistant to prior
HER2-targeted therapies," said Rob
Iannone, M.D., M.S.C.E., executive vice president, global
head of research and development of Jazz Pharmaceuticals. "The
abstracts accepted for presentation by Jazz and our partners at
this year's meeting demonstrate our commitment to advancing our
portfolio of innovative oncology products and investigational
therapies at all stages of development as we seek to deliver on our
goal to help people with cancer live longer, fuller lives."
The full ASCO abstracts will be available on May 23, 2024,
after 5 p.m. ET. The abstract titles are available
at: https://www.asco.org/abstracts.
A full list of Jazz or partner-supported presentations at the
2024 ASCO Annual Meeting follows:
Zanidatamab
Presentation Title
|
Author
|
Presentation Details
|
Zanidatamab in
previously-treated HER2+ BTC: OS and longer follow-up from the
phase 2b HERIZON-BTC-01 study
|
Shubham Pant, Jia Fan,
Do-Youn Oh, Hye Jin Choi, Jin Won Kim, Heung-Moon Chang, Lequn Bao,
Hui-Chuan Sun, Teresa Macarulla, Feng Xie, Jean-Philippe Metges,
Jie-Er Ying, John A Bridgewater, Mohamedtaki A Tejani, Emerson Y
Chen, Harpreet Wasan, Michel Ducreux, Yi Zhao, Phillip M Garfin,
James J Harding
|
- Type:
Poster
- Session:
Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and
Hepatobiliary
- Date/Time:
Saturday, June 1, 2024, 1:30-4:30 PM CDT
- Number:
4091
|
Zepzelca
Presentation
Title
|
Author
|
Presentation
Details
|
Real-world safety and
Healthcare Resource Utilization (HCRU) of lurbinectedin in patients
with SCLC: Jazz EMERGE 402 updated analysis
|
Firas Badin, Philip
Lammers, Mehul Patel, Leonid Shunyakov, Dennis Slater, Catherine
Labbé, Navit Naveh, Anne Boccuti, Raj Hanvesakul, Wenyan Li, Badri
Rengarajan, Balazs Halmos
|
Type:
ePublication
Number:
e23266
|
Efficacy and safety of
lurbinectedin with irinotecan in a phase 2 expansion cohort of
patients with synovial sarcoma
(PharmaMar-supported
presentation)
|
Gregory M Cote, Javier
Martin Broto, Sant P Chawla, Bruno Bockorny, Alejandro Falcon,
Antonio Lopez Pousa, Luis Paz-Ares, Benjamin Verret, Sara Martinez,
Sonia Extremera, Martin Cullell-Young, Salvador Fudio, Carmen
Kahatt, Ali Zeaiter, Axel Le Cesne
|
Type:
Poster
Session:
Sarcoma
Date/Time:
Saturday, June 1, 2024, 1:30-4:30 PM CDT
Number:
11560
|
Randomized Controlled,
Open-label, Phase IIb/III Study of Lurbinectedin in Combination
with Doxorubicin versus Doxorubicin Alone as First-line Treatment
in Patients with Metastatic Leiomyosarcoma – Trial in
progress (PharmaMar-supported presentation)
|
Gregory M Cote, Sant P
Chawla, George Demetri, Bernd Kasper, Robin Jones, Javier Martin
Broto, Joseph Wooley, Mia Weiss, Salvatore Tafuto, Giuseppe
Badalamenti, Irene Carrasco, Paloma Peinado, Jean-Yves Blay, Gaston
Boggio, Cristian Fernandez, Antonio Nieto, Carmen Kahatt, Ali
Zeaiter, Axel Le Cesne
|
Type:
Poster
Session:
Sarcoma
Date/Time:
Saturday, June 1, 2024, 1:30-4:30 PM CDT
Number:
TPS11590
|
A phase II study of
lurbinectedin ± avelumab in small cell carcinoma of the bladder
(LASER) – Trial in Progress
[IST]
|
Nicholas Simon, Elias
Chandran, Scot Niglio, Andre R Kydd, Saad Atiq, Lisa Ley, Lisa
Cordes, Tzu-fang Wang, Salah Boudjadi, Elizabeth Smith, Dilara
Akbulut, Seth Steinberg, Andrea B Apolo
|
Type:
Poster
Session:
Genitourinary Cancer –
Kidney and
Bladder
Date/Time:
Sunday, June 2, 2024, 9:00 AM -
12:00 PM CDT
Number:
TPS4629
|
Efficacy and safety of
lurbinectedin in combination with irinotecan in patients with
relapsed SCLC: results from a phase 2 expansion cohort
(PharmaMar-supported
presentation)
|
Luis Paz-Ares,
Alejandro Falcon, Alejandro Navarro, Amparo Sanchez, Gregory M
Cote, Javier Molina-Cerrillo, Vicente Alonso, Javier Baena, Ana
Gil, Santiago Ponce-Aix, Helena Bote de Cabo, Sara Martinez, Julia
Martinez, Jose Antonio López-Vilariño, Carmen Kahatt, Ali Zeaiter,
Javier Gomez, Jon Zugazagoitia
|
Type:
Poster
Session: Lung
Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic
Cancers
Date/Time:
Monday, June 3, 2024, 1:30-4:30 PM CDT
Number:
8094
|
JZP898
Presentation
Title
|
Author
|
Presentation
Details
|
A phase 1/1b
first-in-human (FIH) study of JZP898 as monotherapy and in
combination with pembrolizumab in adult patients with advanced or
metastatic solid tumors – Trial in Progress
|
Meredith McKean, Thomas
Hutson, Sarina A Piha-Paul, Ida Micaily, Mingxiang Liao, Robin
Humphreys, Graham Brock, Natasha Sahr, Vian Amber, Alexander
Spira
|
Type:
Poster
Session:
Developmental Therapeutics—Molecularly Targeted Agents and Tumor
Biology
Date/Time:
Saturday, June 1, 2024. 9:00 AM–12:00 PM CDT
Number:
TPS3190
|
Rylaze
Presentation
Title
|
Author
|
Presentation
Details
|
Recombinant
Erwinia asparaginase (JZP458) in acute lymphoblastic
leukemia/lymphoblastic lymphoma (ALL/LBL): post hoc analysis of
adverse events of interest from AALL1931
|
Etsuko Aoki, Luke
Maese, Mignon L Loh, Shirali Agarwal, Vijayalakshmi Chandrasekaran,
Yali Liang, Nalina Dronamraju, Robert Iannone, Lewis B Silverman,
Elizabeth A Raetz, Rachel E Rau
|
Type:
Poster
Session:
Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and
Allotransplant
Date/Time:
Monday, June 3, 2024, 9:00 AM–12:00 PM CDT
Number:
6521
|
About Zanidatamab
Zanidatamab is an investigational bispecific antibody that can
simultaneously bind two non-overlapping epitopes of HER2, known as
biparatopic binding. This unique design and increased binding
results in multiple mechanisms of action, including dual HER2
signal blockade, removal of HER2 protein from the cell surface, and
immune-mediated cytotoxicity leading to encouraging antitumor
activity in patients. Zanidatamab is being developed in multiple
clinical trials as a targeted treatment option for patients with
solid tumors that express HER2. Zanidatamab is being developed by
Jazz and BeiGene, Ltd. (BeiGene) under license agreements from
Zymeworks, which first developed the molecule.
The U.S. Food and Drug Administration (FDA) has granted
Breakthrough Therapy designation for zanidatamab development in
patients with previously treated HER2 gene-amplified biliary tract
cancers (BTC), and two Fast Track designations for zanidatamab: one
as a single agent for refractory BTC and one in combination with
standard of care chemotherapy for 1L gastroesophageal
adenocarcinoma (GEA). Additionally, zanidatamab has received Orphan
Drug designations from FDA for the treatment of BTC and GEA, as
well as Orphan Drug designation from the European Medicines Agency
for the treatment of BTC and gastric cancer. Zanidatamab was also
granted Breakthrough Therapy designation from the Center for Drug
Evaluation (CDE) in China.
About
Zepzelca® (lurbinectedin)
Zepzelca is
an alkylating drug that binds guanine residues within DNA. This
triggers a cascade of events that can affect the activity of DNA
binding proteins, including some transcription factors, and DNA
repair pathways, resulting in disruption of the cell cycle and
eventual cell death.1
The FDA approved Zepzelca under
accelerated approval in June 2020 for the treatment of
adult patients with metastatic SCLC with disease progression on or
after platinum-based chemotherapy. The approval is based on overall
response rate (ORR) and duration of response demonstrated in an
open-label, monotherapy clinical study. In December 2021,
Jazz and PharmaMar announced the initiation of LAGOON, a
confirmatory Phase 3 clinical trial
of Zepzelca for the treatment of patients with
relapsed small cell lung cancer. If positive, LAGOON could confirm
the benefit of Zepzelca in the treatment of small
cell lung cancer (SCLC) when patients progress following 1L
treatment with a platinum-based regimen and support full approval
in the U.S.
Zepzelca is a prescription medicine used to treat
adults with SCLC that has spread to other parts of the body
(metastatic) and who have received treatment with chemotherapy that
contains platinum, and it did not work or is no longer
working. Zepzelca is approved based on response
rate and how long the response lasted. Additional studies will
further evaluate the benefit of Zepzelca for this
use.
Important Safety Information for ZEPZELCA
Before receiving ZEPZELCA, tell your healthcare provider
about all of your medical conditions, including if you:
- have liver or kidney problems.
- are pregnant or plan to become pregnant. ZEPZELCA can harm your
unborn baby.
Females who are able to become pregnant:
- Your healthcare provider should do a pregnancy test before you
start treatment with ZEPZELCA.
- You should use effective birth control (contraception) during
treatment with and for 6 months after your last dose of
ZEPZELCA.
- Tell your healthcare provider right away if you become pregnant
or think that you are pregnant during treatment with ZEPZELCA.
Males with female partners who are able to become
pregnant should use effective birth control during
treatment with and for 4 months after your last dose of
ZEPZELCA.
Females who are breastfeeding or plan to breastfeed. It is not
known if ZEPZELCA passes into your breastmilk. Do not breastfeed
during treatment with ZEPZELCA and for 2 weeks after your last dose
of ZEPZELCA. Talk to your healthcare provider about the best way to
feed your baby during treatment with ZEPZELCA.
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements. Certain other
medicines may affect how ZEPZELCA works.
What should I avoid while using ZEPZELCA?
Avoid eating
or drinking grapefruit, Seville
oranges, or products that contain grapefruit juice and Seville oranges during treatment with
ZEPZELCA.
ZEPZELCA can cause serious side effects, including:
- Low blood cell counts. Low blood counts including low
neutrophil counts (neutropenia) and low platelet counts
(thrombocytopenia) are common with ZEPZELCA and can also be severe.
Some people with low white blood cell counts may get fever, or an
infection throughout the body (sepsis), that can cause death. Your
healthcare provider should do blood tests before you receive each
treatment with ZEPZELCA to check your blood cell counts.
Tell your healthcare provider right away if you
develop:
- fever or any other signs of infection
- unusual bruising or bleeding
- tiredness
- pale colored skin
- Liver problems. Increased liver function tests are
common with ZEPZELCA and can also be severe. Your healthcare
provider should do blood tests to check your liver function before
you start and during treatment with ZEPZELCA.
Tell your healthcare provider right away if you develop
symptoms of liver problems including:
- loss of appetite
- nausea or vomiting
- pain on the right side of your stomach area (abdomen)
- Your healthcare provider may temporarily stop treatment, lower
your dose, or permanently stop ZEPZELCA if you develop low blood
cell counts or liver problems during treatment with ZEPZELCA.
The most common side effects of ZEPZELCA include:
- tiredness
- low white and red blood cell counts
- increased kidney function blood test (creatinine)
- increased liver function blood tests
- increased blood sugar (glucose)
- nausea
- decreased appetite
- muscle and joint (musculoskeletal) pain
- low level of albumin in the blood
- constipation
- trouble breathing
- low levels of sodium and magnesium in the blood
- vomiting
- cough
- diarrhea
These are not all of the possible side effects of
ZEPZELCA.
Call your doctor for medical advice about side effects. You
are encouraged to report negative side effects of prescription
drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088. You may also report side effects to Jazz
Pharmaceuticals at 1-800-520-5568.
More information about Zepzelca, including Full Prescribing
Information and Patient Information, is
available here.
ZEPZELCA is a trademark of Pharma Mar, S.A. used
by Jazz Pharmaceuticals under license.
About JZP898
JZP898 (also known as WTX-613) is an
investigational differentiated, conditionally-activated interferon
alpha (IFNα) INDUKINE™ molecule. JZP898 is an engineered IFN⍺2b
cytokine pro-drug that is activated specifically within the tumor
microenvironment where it can stimulate IFNα receptors on
cancer-fighting immune effector cells. JZP898 was created
leveraging Werewolf Therapeutics' proprietary PREDATOR™ protein
engineering technology, which integrates specialized protein design
elements to enhance activity, stability and tumor selectivity
within a single molecule, called INDUKINE molecules.
About RYLAZE® (asparaginase erwinia
chrysanthemi (recombinant)-rywn)
RYLAZE, also known as JZP458, is approved in the U.S. for
use as a component of a multi-agent chemotherapeutic regimen for
the treatment of acute lymphoblastic leukemia (ALL) and
lymphoblastic lymphoma (LBL) in adult and pediatric patients one
month or older who have developed hypersensitivity to E.
coli-derived asparaginase. RYLAZE has orphan drug
designation for the treatment of ALL/LBL in the United States. RYLAZE is a recombinant
erwinia asparaginase that uses a novel Pseudomonas
fluorescens expression platform. JZP458 was granted Fast
Track designation by the U.S. Food and Drug
Administration (FDA) in October 2019 for the
treatment of this patient population. RYLAZE was approved as part
of the Real-Time Oncology Review program, an initiative of
the FDA's Oncology Center of Excellence designed for
efficient delivery of safe and effective cancer treatments to
patients.4
The full U.S. Prescribing Information for
RYLAZE is available
at: https://pp.jazzpharma.com/pi/rylaze.en.USPI.pdf
Important Safety Information for RYLAZE
RYLAZE should not be given to people who have had:
- Serious allergic reactions to RYLAZE
- Serious swelling of the pancreas (stomach pain), serious blood
clots, or serious bleeding during previous asparaginase
treatment
RYLAZE may cause serious side effects,
including:
- Allergic reactions (a feeling of tightness in your throat,
unusual swelling/redness in your throat and/or tongue, rash, or
trouble breathing), some of which may be life-threatening
- Swelling of the pancreas (stomach pain), which, if left
untreated, may be fatal
- Blood clots (may be experienced as headache, arm or leg
swelling, shortness of breath, or chest pain), which may be
life-threatening
- Bleeding, which may be life-threatening
- Liver problems
Contact your doctor immediately if any of these side effects
occur.
Some of the most common side effects with
RYLAZE include: liver problems, nausea and vomiting, bone
and muscle pain, infection, tiredness, headache, fever with low
white blood cell count, fever, bleeding, mouth swelling (sometimes
with sores), pain in the abdomen, decreased appetite, allergic
reactions, high blood sugar levels, diarrhea, swelling of the
pancreas, and low levels of potassium in your blood.
RYLAZE can harm your unborn baby. Inform your doctor if you are
pregnant, planning to become pregnant, or nursing. Females of
reproductive potential should use effective contraception (other
than hormonal contraceptives) during treatment and for 3 months
following the final dose. Do not breastfeed while receiving
RYLAZE and for 1 week after the final dose.
Tell your healthcare provider if there are any side effects
that are bothersome or that do not go away.
These are not all the possible side effects of RYLAZE. For
more information, ask your healthcare provider.
Call your doctor for medical advice about any side
effects.
You are encouraged to report negative side effects of
prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088
(1-800-332-1088).
About Jazz Pharmaceuticals
Jazz Pharmaceuticals plc
(Nasdaq: JAZZ) is a global biopharma company whose purpose is to
innovate to transform the lives of patients and their families. We
are dedicated to developing life-changing medicines for people with
serious diseases—often with limited or no therapeutic options. We
have a diverse portfolio of marketed medicines, including leading
therapies for sleep disorders and epilepsy, and a growing portfolio
of cancer treatments. Our patient-focused and science-driven
approach powers pioneering research and development advancements
across our robust pipeline of innovative therapeutics in oncology
and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development
laboratories, manufacturing facilities and employees in multiple
countries committed to serving patients worldwide. Please visit
www.jazzpharmaceuticals.com for more information.
Jazz Pharmaceuticals plc Caution Concerning
Forward-Looking Statements
This press release contains
forward-looking statements, including, but not limited to,
statements related to growing our portfolio of innovative oncology
products and investigational therapies at all stages of development
as we seek to deliver on our goal to help people with cancer live
longer, fuller lives, and other statements that are not historical
facts. These forward-looking statements are based on Jazz
Pharmaceuticals' current plans, objectives, estimates, expectations
and intentions and inherently involve significant risks and
uncertainties. Actual results and the timing of events could differ
materially from those anticipated in such forward-looking
statements as a result of these risks and uncertainties, which
include, without limitation, risks and uncertainties associated
with pharmaceutical product development, and other risks and
uncertainties affecting Jazz Pharmaceuticals and its development
programs, including those described from time to time under the
caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals plc's
Securities and Exchange Commission filings and reports (Commission
File No. 001-33500), including Jazz Pharmaceuticals' Annual Report
on Form 10-K for the year ended December 31,
2023, and future filings and reports by Jazz
Pharmaceuticals. Other risks and uncertainties of which Jazz
Pharmaceuticals is not currently aware may also affect Jazz
Pharmaceuticals' forward-looking statements and may cause actual
results and the timing of events to differ materially from those
anticipated. The forward-looking statements herein are made only as
of the date hereof or as of the dates indicated in the
forward-looking statements, even if they are subsequently made
available by Jazz Pharmaceuticals on its website or otherwise. Jazz
Pharmaceuticals undertakes no obligation to update or supplement
any forward-looking statements to reflect actual results, new
information, future events, changes in its expectations or other
circumstances that exist after the date as of which the
forward-looking statements were made.
Contacts:
Jazz Media Contact:
Kristin
Bhavnani
Head of Global Strategic Brand Engagement
Jazz Pharmaceuticals plc
CorporateAffairsMediaInfo@jazzpharma.com
Ireland +353 1 637 2141
U.S. +1 215 867 4948
Jazz Investor Contact:
Andrea
N. Flynn, Ph.D.
Vice President, Head, Investor Relations
Jazz Pharmaceuticals plc
investorinfo@jazzpharma.com
Ireland +353 1 634 3211
U.S. +1 650 496 2717
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