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NOW APPROVED for First-Line Maintenance

ZEPZELCA + atezolizumab is indicated for ES-SCLC maintenance therapy in adults without disease progression after induction with chemotherapy + atezolizumab

OPEN THE CHANCE FOR MORE LIFE IN ES-SCLC WITH ZEPZELCA

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The first and only regimen to demonstrate superior OS and PFS in maintenance1,2

IMforte: A large Phase 3 trial with >450 patients with ES-SCLC in the maintenance phase1,2

Diagram showing the induction, randomization, and maintenance phase, with key eligibility criteria, treatment arms, and primary/secondary endpoints.
Efficacy endpoint assessments started from randomization into the maintenance phase; the median time from the start of induction to the time of randomization was 3.2 months2
In patients who had an ongoing response or stable disease after induction,

ZEPZELCA + atezolizumab delivered superior and clinically meaningful OS in IMforte1

Kaplan-Meier Plot of OS1,2
Median OS KM curve: 13.2 months for ZEPZELCA + atezolizumab (n=242) vs 10.6 months for atezolizumab (n=241) [HR=0.73; 95% CI: 0.57, 0.95; P=0.0174(a)]. Nearly 3-month survival benefit (2.6 months).
Median OS KM curve: 13.2 months for ZEPZELCA + atezolizumab (n=242) vs 10.6 months for atezolizumab (n=241) [HR=0.73; 95% CI: 0.57, 0.95; P=0.0174(a)]. Nearly 3-month survival benefit (2.6 months).
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Post-induction randomization: OS was defined as the time from randomization into the maintenance phase to death from any cause.2

OS Rate 12 MONTHS2,b
ZEPZELCA +
atezolizumab 0%
Atezolizumab 0%
In patients who had an ongoing response or stable disease after induction,

ZEPZELCA + atezolizumab delivered superior and clinically meaningful PFS in IMforte1

Kaplan-Meier Plot of IRF-Assessed PFS1,2
Median PFS KM curve: 5.4 months for ZEPZELCA + atezolizumab (n=242) vs 2.1 months for atezolizumab (n=241) [HR=0.54; 95% CI: 0.43, 0.67; P<0.0001(b)]. Over 3-month survival benefit (3.3 months).
Median PFS KM curve: 5.4 months for ZEPZELCA + atezolizumab (n=242) vs 2.1 months for atezolizumab (n=241) [HR=0.54; 95% CI: 0.43, 0.67; P<0.0001(b)]. Over 3-month survival benefit (3.3 months).
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Post-induction randomization: PFS was defined as the time from randomization into the maintenance phase to disease progression per RECIST v1.1 as assessed by the IRF, or death from any cause, whichever occurred first.2

PFS Rate 6 MONTHS2,b
ZEPZELCA +
atezolizumab 0%
Atezolizumab 0%

a Based on the 2-sided stratified log-rank test and compared to the alpha boundary of 0.0313 (2-sided) for this interim OS analysis.1

b These endpoints were prespecified and were not powered to demonstrate statistical significance. No conclusions can be drawn from these analyses.2

c Based on the 2-sided stratified log-rank test and compared to the alpha boundary of 0.001 (2-sided) for this final PFS analysis.1

Meet the Expert: Dr. Wade. T. Iams pdf.

Meet the Expert

Featuring: Dr. Wade T. Iams

Dr. Iams explores the clinical progress in first-line SCLC treatment, focusing on effective chemo-immunotherapy maintenance strategies.

Download Now

No new or unexpected safety signals were observed beyond the established safety profiles of ZEPZELCA and atezolizumab1-3,a

DISCONTINUATION

Low discontinuation rate of ZEPZELCA due to an adverse reaction (5%)1

The adverse reaction resulting in permanent discontinuation in ≥1% of patients who received ZEPZELCA was decreased neutrophil count

Icon of an IV bag with a stop sign symbol, representing dose discontinuation

DOSE REDUCTION

15% of patients had dose reductions of ZEPZELCA due to an adverse reaction1

Adverse reactions which required dosage reduction in ≥2% of patients included decreased platelet count, fatigue, nausea, and vomiting

Icon of an IV bag with a down arrow symbol, representing dose reduction

DOSE INTERRUPTION

25% of patients had an adverse reaction leading to interruption of ZEPZELCA1

Adverse reactions which required dosage interruption in ≥2% of patients included anemia, fatigue, decreased neutrophil count, and decreased platelet count

Icon of an IV bag with a pause symbol, representing dose interruption

ADVERSE REACTIONS

Fatal adverse reactions occurred in 5% of patients receiving ZEPZELCA + atezolizumab1

These included pneumonia (3 patients), sepsis (3 patients), cardio-respiratory arrest (2 patients), myocardial infarction (2 patients), and febrile neutropenia (1 patient)

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Adverse Reactions in ≥10% of Patients Receiving ZEPZELCA + Atezolizumab1,a

Adverse Reaction ZEPZELCA + Atezolizumab
(n=242)		 Atezolizumab
(n=240)
All Grades
(%)		 Grade 3 or 4
(%)		 All Grades
(%)		 Grade 3 or 4
(%)
Gastrointestinal
Nausea 36 3 4 1
Diarrheab 15 0 8 0
Vomiting 14 1 3 0
Constipation 12 0 6 1
General disorders and administration site conditions
Fatiguec 32 5 13 2
Musculoskeletal and connective tissue disorders
Musculoskeletal paind 19 2 16 1
Metabolism and nutrition
Decreased appetite 17 0 7 0
Respiratory, thoracic, and mediastinal disorders
Coughe 12 0 8 0
Dyspneaf 11 2 10 2

Graded per NCI CTCAE v5.0.

a242 patients in the ZEPZELCA + atezolizumab group and 240 patients in the atezolizumab group were included in the safety analysis set.2

bIncludes diarrhea and colitis.

cIncludes fatigue and asthenia.

dIncludes arthralgia, arthritis, back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal pain, myalgia, neck pain, non-cardiac chest pain, and pain in extremity.

eIncludes cough, productive cough, and upper-airway cough syndrome.

fIncludes dyspnea and dyspnea exertional.

Same-day dosing schedule with ZEPZELCA + atezolizumab

Consistent ZEPZELCA dosing across lines of therapy1
Stopwatch icon
3.2 mg/m2
by IV infusion over
60 minutes
0
Calendar icon with text "every 21 days."
until disease
progression or
unacceptable toxicity
For the recommended dosage of atezolizumab or atezolizumab
and hyaluronidase-tqjs, refer to the respective Prescribing Information
  • When administered on the same day, atezolizumab or atezolizumab and hyaluronidase-tqjs should be administered first, followed by ZEPZELCA
  • Initiate treatment with ZEPZELCA only if ANC is ≥1,500 cells/mm3 and platelet count is ≥100,000/mm3
  • If discontinuation of atezolizumab is required due to an immune-related severe AE, treatment with ZEPZELCA may be continued at the same dose as a single agent. If immune toxicity does not resolve or recurs despite discontinuation of atezolizumab, permanently discontinue ZEPZELCA

Recommended Prophylactic Medications1

When using ZEPZELCA + atezolizumab, administer primary prophylaxis with G-CSF to reduce the risk of febrile neutropenia

To reduce the risk of nausea, administer the following pre-infusion medications prior to Cycle 1 and consider for subsequent cycles:

  • Corticosteroids (IV dexamethasone 8 mg or equivalent)
  • Serotonin antagonists (IV ondansetron 8 mg or equivalent)
No additional monitoring requirements specific to ZEPZELCA + atezolizumab1*

*Patient monitoring is at the discretion of the provider. Please see the individual product Prescribing Information for additional information.

Access and support through JazzCares

Help patients enroll in JazzCares to access their medication and receive personalized support throughout their ZEPZELCA + atezolizumab treatment
Reach out to a Jazz Oncology Business Manager
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Please see pricing information for:
Colorado Prescribers and Pharmacists
Connecticut Prescribers and Pharmacists

ZEPZELCA materials for you and your patients

Patient-Doctor Discussion Guide pdf.
Patient–Doctor Discussion Guide

A guide to help you have meaningful conversations with your patients about ZEPZELCA as first-line maintenance therapy.

 
Brochure for Healthcare Providers pdf.
Brochure for Healthcare Providers

Key details about ZEPZELCA + atezolizumab, including efficacy results, safety profile, recommended dosage, and more.

 
Meet the Expert: Dr. Wade. T. Iams pdf.
Meet the Expert: Dr. Wade T. Iams

Dr. Iams explores the clinical progress in first-line SCLC treatment, focusing on effective chemo-immunotherapy maintenance strategies.

 
ZEPZELCA Prescribing Information pdf.
ZEPZELCA Prescribing Information

Full prescribing information for ZEPZELCA.

 

AE=adverse event; ANC=absolute neutrophil count; CI=confidence interval; CNS=central nervous system; DOR=duration of response; ECOG PS=Eastern Cooperative Oncology Group Performance Status; ES-SCLC=extensive-stage small cell lung cancer; G-CSF=granulocyte colony-stimulating factor; HR=hazard ratio; INV=investigator; IRF=independent review facility; IV=intravenous; mOS=median overall survival; mPFS=median progression-free survival; NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events; ORR=objective response rate; OS=overall survival; PFS=progression-free survival; q3w=every 3 weeks; RECIST=Response Evaluation Criteria in Solid Tumors; v=version.

INDICATION

ZEPZELCA (lurbinectedin) for injection 4 mg, in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs, is indicated for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin and etoposide.

IMPORTANT SAFETY INFORMATION

Myelosuppression

ZEPZELCA can cause severe and fatal myelosuppression including febrile neutropenia and sepsis, thrombocytopenia and anemia.

Administer ZEPZELCA only to patients with baseline neutrophil count of at least 1,500 cells/mm3 and platelet count of at least 100,000/mm3. To reduce the risk of febrile neutropenia during treatment with ZEPZELCA in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs, administer granulocyte colony-stimulating factor (G-CSF). Monitor blood counts including neutrophils, red blood cells and platelets prior to each ZEPZELCA administration. For neutrophil count less than 500 cells/mm3 or any value less than lower limit of normal, administer G-CSF. Withhold, reduce the dose, or permanently discontinue ZEPZELCA based on severity.

In the IMforte study, primary prophylaxis of G-CSF was administered to 84% of patients. Based on laboratory values, decreased neutrophils occurred in 36%, including 18% Grade 3 or Grade 4 in patients who received ZEPZELCA in combination with atezolizumab. The median time to onset of Grade 3 and 4 decreased neutrophil cells was 31 days and a median duration of 10 days. Febrile neutropenia occurred in 1.7%. Sepsis occurred in 1%. There were 7 fatal infections: pneumonia (n=3), sepsis (n=3), and febrile neutropenia (n=1).

Based on laboratory values, decreased platelets occurred in 54%, including 15% Grade 3 or Grade 4 in patients who received ZEPZELCA in combination with atezolizumab. The median time to onset of Grade 3 and 4 decreased platelet cells was 31 days and a median duration of 12 days.

Based on laboratory values, decreased hemoglobin occurred in 51%, including 13% Grade 3 or Grade 4 in patients who received ZEPZELCA in combination with atezolizumab. The median time to onset of Grade 3 and 4 decreased hemoglobin was 64 days and a median duration of 8 days.

Hepatotoxicity

ZEPZELCA can cause hepatotoxicity which may be severe.

Monitor liver function tests prior to initiating ZEPZELCA and periodically during treatment as clinically indicated. Withhold, reduce the dose, or permanently discontinue ZEPZELCA based on severity.

In the IMforte study, based on laboratory values, increased alanine aminotransferase (ALT) occurred in 25%, including 3% Grade 3 or Grade 4 in patients who received ZEPZELCA in combination with atezolizumab. Increased aspartate aminotransferase (AST) occurred in 24% including 3% Grade 3 or Grade 4. The median time to onset of Grade ≥3 elevation in transaminases was 52 days (range: 6 to 337).

Extravasation Resulting in Tissue Necrosis

Extravasation of ZEPZELCA can cause skin and soft tissue injury, including necrosis requiring debridement. Consider use of a central venous catheter to reduce the risk of extravasation, particularly in patients with limited venous access. Monitor patients for signs and symptoms of extravasation during the ZEPZELCA infusion. If extravasation occurs, immediately discontinue the infusion, remove the infusion catheter, and monitor for signs and symptoms of tissue necrosis. The time to onset of necrosis after extravasation may vary.

In the IMforte study, extravasation resulting in skin necrosis occurred in one patient who received ZEPZELCA in combination with atezolizumab.

Administer supportive care and consult with an appropriate medical specialist as needed for signs and symptoms of extravasation. Administer subsequent infusions at a site that was not affected by extravasation.

Rhabdomyolysis

Rhabdomyolysis has been reported in patients treated with ZEPZELCA.

Monitor creatine phosphokinase (CPK) prior to initiating ZEPZELCA and periodically during treatment as clinically indicated. Withhold or reduce the dose based on severity.

In the IMforte study, among 235 patients who had a creatine phosphokinase laboratory evaluation, increased creatine phosphokinase occurred in 9% who received ZEPZELCA in combination with atezolizumab.

Embryo-Fetal Toxicity

ZEPZELCA can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise female patients of reproductive potential to use effective contraception during treatment with ZEPZELCA and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ZEPZELCA and for 4 months after the last dose.

Lactation

There are no data on the presence of ZEPZELCA in human milk, however, because of the potential for serious adverse reactions from ZEPZELCA in breastfed children, advise women not to breastfeed during treatment with ZEPZELCA and for 2 weeks after the last dose.

ADVERSE REACTIONS

Serious adverse reactions occurred in 31% of patients receiving ZEPZELCA in combination with atezolizumab. Serious adverse reactions occurring in >2% were pneumonia (2.5%), respiratory tract infections (2.1%), dyspnea (2.1%), and decreased platelet count (2.1%). Fatal adverse reactions occurred in 5% of patients receiving ZEPZELCA with atezolizumab including pneumonia (3 patients), sepsis (3 patients), cardio-respiratory arrest (2 patients), myocardial infarction (2 patients), and febrile neutropenia (1 patient).

The most common adverse reactions (≥30%), including laboratory abnormalities, in patients who received ZEPZELCA with atezolizumab were decreased lymphocytes (55%), decreased platelets (54%), decreased hemoglobin (51%), decreased neutrophils (36%), nausea (36%), and fatigue/asthenia (32%).

DRUG INTERACTIONS

Effect of CYP3A Inhibitors and Inducers

Avoid coadministration with a strong or a moderate CYP3A inhibitor (including grapefruit and Seville oranges) as this increases lurbinectedin systemic exposure which may increase the incidence and severity of adverse reactions to ZEPZELCA. If coadministration cannot be avoided, reduce the ZEPZELCA dose as appropriate.

Avoid coadministration with a strong CYP3A inducer as it may decrease systemic exposure to lurbinectedin, which may decrease the efficacy of ZEPZELCA.

GERIATRIC USE

Of the 242 patients with ES-SCLC treated with ZEPZELCA and atezolizumab in IMforte, 124 (51%) patients were 65 years of age and older, while 29 (12%) patients were 75 years of age and older. No overall differences in effectiveness were observed between older and younger patients. There was no overall difference in the incidence of serious adverse reactions in patients ≥65 years of age and patients <65 years of age (33% vs. 29%, respectively). There was a higher incidence of Grade 3 or 4 adverse reactions in patients ≥65 years of age compared to younger patients (45% vs. 31%, respectively).

HEPATIC IMPAIRMENT

Avoid administration of ZEPZELCA in patients with severe hepatic impairment. If administration cannot be avoided, reduce the dose. Monitor for increased adverse reactions in patients with severe hepatic impairment.

Reduce the dose of ZEPZELCA in patients with moderate hepatic impairment. Monitor for increased adverse reactions in patients with moderate hepatic impairment.

No dose adjustment of ZEPZELCA is recommended for patients with mild hepatic impairment.

Please see accompanying full Prescribing Information.

References: 1. ZEPZELCA (lurbinectedin) Prescribing Information. Jazz Pharmaceuticals, Inc. 2. Paz-Ares L, Borghaei H, Liu SV, et al. Efficacy and safety of first-line maintenance therapy with lurbinectedin plus atezolizumab in extensive-stage small-cell lung cancer (IMforte): a randomised, multicentre, open-label, phase 3 trial. Lancet. 2025;405(10495):2129–2143. 3. TECENTRIQ® Prescribing Information. Genentech Inc.; 2025.