Jazz Pharmaceuticals Announces First Patient Enrolled in IMforte Phase 3 Trial Evaluating Zepzelca® (lurbinectedin) in Combination with a PD-L1 Inhibitor in Small Cell Lung Cancer
"Small cell lung cancer can progress faster than most forms of lung cancer, although new treatment options can prolong life and improve long-term care options," said
"We've already witnessed strong clinical demand for Zepzelca as a therapy for metastatic small cell lung cancer patients in the second-line setting," said
About the IMforte Phase 3 Trial
As part of the IMforte Phase 3, randomized, multicenter maintenance trial, Jazz and Roche will evaluate the efficacy, safety and pharmacokinetics of Zepzelca plus Tecentriq in adults with ES-SCLC following induction therapy with carboplatin, etoposide and atezolizumab. The primary objective is to determine the ability of this new combination to improve outcomes for patients with ES-SCLC, compared with standard-of-care first-line maintenance as measured by progression-free survival and overall survival. The trial is sponsored by Roche and co-funded by
If successful, the trial could potentially support an FDA supplemental new drug application for Zepzelca combined with Tecentriq in first-line maintenance ES-SCLC.
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
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:
- 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.
- 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
- 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:
- low white and red blood cell counts
- increased kidney function blood test (creatinine)
- increased liver function blood tests
- increased blood sugar (glucose)
- decreased appetite
- muscle and joint (musculoskeletal) pain
- low level of albumin in the blood
- trouble breathing
- low levels of sodium and magnesium in the blood
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 PharmaMar, S.A. used by Jazz Pharmaceuticals under license.
About Small Cell
In the U.S., approximately 13 percent of lung cancers are small cell.2 There are approximately 30,000 to 35,000 patients in the
Caution Concerning Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to
Jazz Media Contact:
Jazz Investor Contact:
Vice President, Head, Investor Relations
1 ZEPZELCA (lurbinectedin) Prescribing Information.
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