Full Press Release Details
DUBLIN , March 15, 2023 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ ) today announced that the company, along with its partners, will present five new abstracts at the American Association for Cancer Research (AACR) Annual Meeting from April 14-19, 2023 . Research findings to be presented include data from company-sponsored and collaborative trials studying Zepzelca ® (lurbinectedin), zanidatamab and JZP898.
"The data Jazz and our partners are presenting at AACR this year demonstrate our commitment to advancing the next generation of oncology care, including our ongoing research for lurbinectedin," said Rob Iannone , M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. "Over the last year, Jazz has added promising new immuno-oncology and targeted therapy candidates to our pipeline – including zanidatamab, a novel late-stage HER2-targeted bispecific antibody – and progressed ongoing development programs with the goal of improving standards of care across multiple cancer types with significant unmet need and poor outcomes."
Data highlights at the AACR Annual Meeting include:
The AACR abstracts are available at: https://www.abstractsonline.com/pp8/#!/10828/
The full list of Jazz-supported presentations at the 2023 AACR Annual Meeting are:
Zepzelca ® (lurbinectedin) Presentations
| Presentation Title | Author | Presentation Details |
| High SLFN11 expression correlates with sensitivity to lurbinectedin in small cell lung cancer (SCLC) models | Gupta A., et al. | Type : Poster Session: Biomarkers of Therapeutic Benefit 2 Date : Monday, April 17, 2023, 9:00 AM - 12:30 PM Abstract number: 2145 |
| Lurbinectedin exhibits com binatorial activity with BCL2/BCL2L1 inhibi tors in vitro and in vivo by modulation of MCL1 expression | Vaidya K.S., et al. | Type: Poster Session: Cell Death Pathways/ Molecular Classifications of Tumors for Diagnostics, Prognostics, and Therapeutic Outcomes Date: Wednesday, April 19, 2023, 9:00 AM - 12:30 PM Abstract number : 6155 |
| Lurbinectedin shows potent activity in all four molecular subtypes of small cell lung cancer (SCLC) and POU2F3 and SLFN11 are biomarkers for a better response | Diez M.M., et al. | Type: Poster Session: DNA-reactive Agents, HDAC and Methyltransferase Inhibitors, and Tubulin Agents Date: Wednesday, April 19, 2023, 9:00 AM - 12:30 PM Abstract number : 6247 |
Zanidatamab Presentation*
| Presentation Title | Author | Presentation Details |
| ERBB2 amplification detected in ctDNA as a surrogate for tumor tissue FISH analysis of HER2 status in phase 1 study with zanidatamab for the treatment of locally advanced or metastatic HER2 expressing cancers | Shpektor D., et al. | Type: Poster Session: Phase I Clinical Trials 2 Date: Tuesday, April 18, 2023, 1:30 PM - 5:00 PM Abstract number : CT278 |
| *Clinical trial abstract texts are embargoed until noon ET on April 14, 2023. |
JZP898 Presentation
| Presentation Title | Author | Presentation Details |
| WTX-613, (JZP898) a selectively activated IFNα INDUKINE™ molecule, reprograms the tumor microenvironment and generates robust anti-tumor immunity as a monotherapy and in combination with checkpoint inhibitors | Nirschl CJ, et al. | Type: Poster Session: Immunomodulatory Agents and Interventions 1 Date: Monday April 17, 2023 9:00 AM - 12:30 PM Abstract number: 1817 |
About Zanidatamab
Zanidatamab is an investigational bispecific antibody, based on Zymeworks' Azymetric™ platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging antitumor activity in patients. Zymeworks, along with collaborators Jazz and BeiGene, Ltd. (BeiGene), are developing zanidatamab in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2.
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for zanidatamab 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 first-line 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 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. 3
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 successful, LAGOON will serve as the confirmatory trial for Zepzelca to support full approval in the U.S.
Zepzelca is a prescription medicine used to treat adults with small cell lung cancer 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. Zepzelca is not approved as part of a combination therapy or as a first-line maintenance treatment for patients with extensive-stage small cell lung cancer.
Important Safety Information for Patients
Before receiving ZEPZELCA, tell your healthcare provider about all of your medical conditions, including if you:
Females who are able to become pregnant:
Males with female partners who are able to become pregnant should use effective birth control during treatment with and for 4 months after your final 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 final 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, or products that contain grapefruit juice during treatment with ZEPZELCA.
ZEPZELCA can cause serious side effects, including:
Tell your healthcare provider right away if you develop:
Tell your healthcare provider right away if you develop symptoms of liver problems including:
The most common side effects of ZEPZELCA include:
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.
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 Jazz Pharmaceuticals plc
Jazz Pharmaceuticals plc (Nasdaq: JAZZ ) is a global biopharmaceutical 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 and novel product candidates, from early- to late-stage development, in neuroscience and oncology. Within these therapeutic areas, we are identifying new options for patients by actively exploring small molecules and biologics, and through innovative delivery technologies and cannabinoid science. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. Please visit www.jazzpharmaceuticals.com for more information.
Caution Concerning Forward-Looking Statements
Jazz Media Contact: Kristin Bhavnani Head of Global Corporate Communications Jazz Pharmaceuticals plc [email protected] 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 [email protected] Ireland +353 1 634 3211 U.S. +1 650 496 2717
1 https://www.abstractsonline.com/pp8/#!/10828/presentation/4120 2 https://www.abstractsonline.com/pp8/#!/10828/presentation/1964 3 ZEPZELCA (lurbinectedin) Prescribing Information. Palo Alto, CA : Jazz Pharmaceuticals, Inc.
SOURCE Jazz Pharmaceuticals plc