Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the company, along with its partners, will present nine abstracts at the American Society of Clinical Oncology (ASCO) Annual Meeting from June 2-6, 2023.
| Data from multiple studies of investigational bispecific drug zanidatamab, including pivotal Phase 2 biliary tract cancers (BTC) trial results, demonstrate breakthrough HER2-targeted pan-tumor potential Nine abstracts accepted for presentation, including two oral presentations, reinforce Jazz’s growing leadership in oncology and commitment to patients through clinically beneficial treatments and novel research Company to host investor webcast on June 2, 2023, to review zanidatamab BTC data presentation DUBLIN, April 27, 2023 /PRNewswire/ --Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) today announced that the company, along with its partners, will present nine abstracts at the American Society of Clinical Oncology (ASCO) Annual Meeting from June 2-6, 2023. Presentations include clinical data from trials of zanidatamab, Zepzelca® (lurbinectedin) and Vyxeos® (daunorubicin and cytarabine). “We are thrilled to present, together with our partner Zymeworks, an oral presentation of pivotal trial results in patients with HER2-positive BTC, an aggressive disease that currently has no FDA-approved HER2-directed treatment options,” said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. “The breadth of oncology data being presented by Jazz and our partners reflects our relentless focus on raising the standard of care for some of the most difficult-to-treat cancers.” Pivotal data from the Phase 2b study of the bispecific antibody zanidatamab in previously treated HER2-amplified BTC was selected by ASCO as an oral presentation. In addition, updated results from a Phase 1b/2 study of zanidatamab in combination with docetaxel as a first-line therapy for patients with advanced HER2-positive breast cancer will be presented by the trial sponsor, BeiGene. Other presentations at the annual meeting feature data from our oncology pipeline and current product portfolio, across a range of solid tumors and hematological malignancies, include:
The full ASCO abstracts will be available on May 25, 2023, after 5 p.m. ET. The abstract titles are available at: https://meetings.asco.org/meetings/2023-asco-annual-meeting/299/program-guide/scheduled-sessions The full list of Jazz or partner-supported presentations at the 2023 ASCO Annual Meeting are: Zanidatamab Presentations
Zepzelca Presentations
Vyxeos (JZP351/CPX315) Presentations
Webcast Information The Company will host a webcast on Friday, June 2, 2023, at 6:45 p.m. CT / 7:45 p.m. ET / 12:45 a.m. IST (June 3) to provide a review of the zanidatamab BTC data presented at the 2023 ASCO Annual Meeting. Jazz senior management will discuss development and commercialization of zanidatamab, and Dr. Shubham Pant, M.D., MBBS, who is presenting the zanidatamab BTC findings at ASCO, will provide an overview of the data. Dr. Pant is a Professor in the Department of Gastrointestinal Medical Oncology with a joint appointment in the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center. Interested parties may register for the call in advance here or via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. A replay of the webcast will be available via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. About Zanidatamab 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 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 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:
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. About Vyxeos® (daunorubicin and cytarabine) liposome for injection In the U.S., Vyxeos (daunorubicin and cytarabine) liposome for injection is indicated for the treatment of newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older.2 More information about Vyxeos in the United States, including Full Prescribing Information, BOXED Warning and Medication Guide, is available here. Important Safety Information for VYXEOS® WARNING: VYXEOS has different dosage recommendations from other medications that contain daunorubicin and/or cytarabine. Do not substitute VYXEOS for other daunorubicin and/or cytarabine-containing products. VYXEOS should not be given to patients who have a history of serious allergic reaction to daunorubicin, cytarabine, or any of its ingredients. VYXEOS can cause a severe decrease in blood cells (red and white blood cells and cells that prevent bleeding, called platelets) which can result in serious infection or bleeding and possibly lead to death. Your doctor will monitor your blood counts during treatment with VYXEOS. Patients should tell the doctor about new onset fever or symptoms of infection or if they notice signs of bruising or bleeding. VYXEOS can cause heart-related side effects. Tell your doctor about any history of heart disease, radiation to the chest, or previous chemotherapy. Inform your doctor if you develop symptoms of heart failure such as:
VYXEOS may cause allergic reactions including anaphylaxis. Seek immediate medical attention if you develop signs and symptoms of anaphylaxis such as:
VYXEOS contains copper and may cause copper overload in patients with Wilson’s disease or other copper-processing disorders. VYXEOS can damage the skin if it leaks out of the vein. Tell your doctor right away if you experience symptoms of burning, stinging, or blisters and skin sores at the injection site. VYXEOS can harm your unborn baby. Inform your doctor if you are pregnant, planning to become pregnant, or nursing. Do not breastfeed while receiving VYXEOS. Females and males of reproductive potential should use effective contraception during treatment and for 6 months following the last dose of VYXEOS. The most common side effects are bleeding events, fever, rash, swelling, nausea, sores in the mouth or throat, diarrhea, constipation, muscle pain, tiredness, stomach pain, difficulty breathing, headache, cough, decreased appetite, irregular heartbeat, pneumonia, blood infection, chills, sleep disorders, and vomiting. 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. About Jazz Pharmaceuticals plc Caution Concerning Forward-Looking Statements
Contacts: Jazz Media Contact: Jazz Investor Contact: References: 1 ZEPZELCA (lurbinectedin) Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc.
SOURCE Jazz Pharmaceuticals plc | ||||||||||||||||||||||||||||||||||||||
Company Codes: NASDAQ-NMS:JAZZ |
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