On April 24, 2024 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the company, along with its partners, will present or publish eight abstracts at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from May 31-June 4, 2024 in Chicago (Press release, Jazz Pharmaceuticals, APR 24, 2024, View Source [SID1234642309]). 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.
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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 (Free ASCO Whitepaper), 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 (Free ASCO Whitepaper) abstracts will be available on May 23, 2024, after 5 p.m. ET. The abstract titles are available at: View Source
A full list of Jazz or partner-supported presentations at the 2024 ASCO (Free ASCO Whitepaper) 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: View Source
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).