On April 27, 2023 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the company, along with its partners, will present nine abstracts at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 2-6, 2023 (Press release, Jazz Pharmaceuticals, APR 27, 2023, View Source [SID1234630636]). Presentations include clinical data from trials of zanidatamab, Zepzelca (lurbinectedin) and Vyxeos (daunorubicin and cytarabine).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"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 (Free ASCO Whitepaper) 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:
An oral presentation from a Jazz-supported Investigator Sponsored Trial (IST) featuring results from a Phase 1b study evaluating the efficacy of lurbinectedin in combination with doxorubicin in soft-tissue sarcoma (STS), which is intended to serve as a lead-in to a randomized Phase 2 trial in leiomyosarcoma (LMS)
A poster presentation of a post-hoc analysis using Phase 3 trial data to investigate the impact of Vyxeos versus 7+3 on cardiac impairment in older adults with newly diagnosed high-risk or secondary acute myeloid leukemia (AML)
The full ASCO (Free ASCO Whitepaper) abstracts will be available on May 25, 2023, after 5 p.m. ET. The abstract titles are available at: View Source
The full list of Jazz or partner-supported presentations at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting are:
Zanidatamab Presentations
Presentation Title
Author
Presentation Details
Results from the pivotal phase 2b HERIZON-BTC-01 study: Zanidatamab in previously treated HER2-amplified biliary tract cancer
Pant, S. et al.
Type: Oral Abstract Session
Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Date: Friday, June 2 (2:45 -5:45 p.m. CDT)
Abstract number: 4008
Zanidatamab, a HER2-targeted bispecific antibody, in combination with docetaxel as first-line therapy for patients with advanced HER2-positive breast cancer: Updated results from a Phase Ib/II study
Wang, X. et al.
Type: Poster Session
Session: Breast Cancer–Metastatic
Date: June 4, 2023 (8:00 -11:00 a.m. CDT)
Abstract number:1044
Zepzelca Presentations
Presentation Title
Author
Presentation Details
A phase III study of lurbinectedin alone or in combination with irinotecan versus investigator’s choice (topotecan or irinotecan) in patients with relapsed small cell lung cancer (SCLC; LAGOON trial)
Besse, B. et al.
Type: Poster Session
Session: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Date: June 4, 2023 (8:00 -11:00 a.m. CDT)
Abstract number: TPS8613
Efficacy and safety of lurbinectedin in elderly patients with relapsed SCLC
Cousin, S. et al.
Type: Poster Session
Session: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Date: June 4, 2023 (8:00 -11:00 a.m. CDT)
Abstract number: 8591
IFCT-2105 LURBICLIN real-world effectiveness and treatment sequences in patients with extensive stage small cell lung cancer (ES-SCLC) who received lurbinectedin as part of the French Early Access Program (EAP-ATU)
Girard, N. et al.
Type: Poster Session
Session: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Date: June 4, 2023 (8:00 -11:00 a.m. CDT)
Abstract number: 8584
Efficacy of combination lurbinectedin and doxorubicin from the Phase 1b soft-tissue sarcoma (STS) lead-In to a randomized Phase 2 trial in leiomyosarcoma (LMS)
[Jazz-Supported IST]
Cote G. et al.
Type: Oral Abstract Session
Session: Sarcoma
Date: June 5, 2023 (11:30 a.m. -2:30 p.m. CDT)
Abstract number: 11507
Vyxeos (JZP351/CPX315) Presentations
Presentation Title
Author
Presentation Details
Survival outcomes with CPX-351 vs 7+3 by baseline bone marrow blast percentage in older adults with newly diagnosed high-risk or secondary acute myeloid leukemia: A 5-year follow-up study
Ritchie, K. et al.
Type: Poster Session
Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Date: June 5, 2023 (8:00 -11:00 a.m. CT)
Abstract number: 7027
Cardiotoxicity of CPX-351 vs 7+3 in patients with untreated high-risk acute myeloid leukemia
Mitchell, J.D. et al.
Type: Poster Session
Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Date: June 5, 2023 (8:00 -11:00 a.m. CT)
Abstract number: 7029
UCHMC 1812: A phase 1b trial of CPX-351 plus gemtuzumab ozogamicin for relapsed/refractory acute myeloid leukemia
[Jazz-Supported IST]
Park, S. et al.
Type: Poster Session
Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Date: June 5, 2023 (8:00 -11:00 a.m. CT)
Abstract number: 7024
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 (Free ASCO Whitepaper) 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 (Free ASCO Whitepaper), 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
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 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:
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 final 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 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:
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 Vyxeos (daunorubicin and cytarabine) liposome for injection
Vyxeos is a liposomal combination of daunorubicin, an anthracycline topoisomerase inhibitor, and cytarabine, a nucleoside metabolic inhibitor.
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:
shortness of breath or trouble breathing
swelling or fluid retention, especially in the feet, ankles, or legs
unusual tiredness
VYXEOS may cause allergic reactions including anaphylaxis. Seek immediate medical attention if you develop signs and symptoms of anaphylaxis such as:
trouble breathing
severe itching
skin rash or hives
swelling of the face, lips, mouth, or tongue
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.