On April 21, 2026 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the Company and its partners will present three rapid oral and seven poster presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place from May 29-June 2, 2026, in Chicago. The data reflect Jazz’s continued momentum in oncology and the Company’s focus on advancing treatment approaches in difficult-to-treat cancers through late-stage clinical research, real-world evidence and ongoing pipeline innovation.
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Key ASCO (Free ASCO Whitepaper) 2026 presentations include:
Data from the Phase 3 HERIZON-GEA-01 trial evaluating Ziihera (zanidatamab-hrii) in combination with chemotherapy with or without the PD-1 inhibitor Tevimbra (tislelizumab) in previously untreated HER2-positive (HER2+) gastroesophageal adenocarcinoma (GEA), including a rapid oral presentation of analyses of progression-free survival (PFS) and overall survival (OS) across PD-L1 subgroups, as well as analyses of the characterization and management of gastrointestinal adverse events.
Analyses from the Phase 3 IMforte trial evaluating Zepzelca (lurbinectedin) plus atezolizumab (Tecentriq) as first-line maintenance treatment in extensive-stage small cell lung cancer (ES-SCLC), including quality-adjusted time without symptoms or toxicity, as well as a rapid oral presentation on outcomes across SCLC molecular subtypes.
"Building on the strength of the HERIZON-GEA-01 trial results, additional analyses being presented at ASCO (Free ASCO Whitepaper) will provide further details on the impact of zanidatamab in HER2+ GEA, including across PD-L1 subgroups. These data will continue to inform treatment decision-making and enable the successful treatment integration of zanidatamab in clinical practice," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals. "Together with additional analyses of Zepzelca from the Phase 3 IMforte study in first-line maintenance extensive-stage small cell lung cancer and progress in our pipeline, these data reflect our growing and increasingly differentiated oncology portfolio, as well as our commitment to advancing innovative approaches for patients facing some of the most difficult-to-treat cancers."
The ASCO (Free ASCO Whitepaper) abstracts are available at: View Source
The full list of Jazz- and partner-supported presentations at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting are:
Zanidatamab Presentations:
Presentation Title
Authors
Presentation Details
Molecular circulating
tumor DNA (ctDNA)
profiling from patients
(pts) treated with
zanidatamab +
chemotherapy (CT) in
first-line (1L) HER2-
positive (HER2+)
advanced or
metastatic
gastroesophageal
adenocarcinoma (mGEA)
Elimova E, Ku GY, Lee KW, Rha SY,
Wienke S, Yalamanchili G, Garfin PM,
Loro E, Shpektor D, Ajani JA
Type: Poster
Session: Poster Session –
Gastrointestinal Cancer-
Gastroesophageal, Pancreatic,
and Hepatobiliary
Date/Time: May 30, 2026,
9 a.m.-Noon CDT
Abstract number: 4050
Real-world treatment
patterns and overall
survival (OS) in
patients (pts) with
HER2-positive
(HER2+) advanced or
metastatic
gastroesophageal
adenocarcinomas
(mGEA) in the US
Dayyani F, Fan X, Zape J, Murphy R,
Betts KA, Wang Y, Wang S, Chao A, Su
W, Fuller DS, Sabater J, Gibson MK,
Enzinger PC
Type: Poster
Session: Poster Session –
Gastrointestinal Cancer-
Gastroesophageal, Pancreatic,
and Hepatobiliary
Date/Time: May 30, 2026, 9
a.m.-Noon CDT
Abstract number: 4053
Characterization and
management of
gastrointestinal (GI)
adverse events (AEs)
with zanidatamab +
chemotherapy (CT) ±
tislelizumab in first-line
(1L) HER2-positive
(HER2+) locally
advanced or
metastatic
gastroesophageal
adenocarcinoma
(mGEA): Analysis
from HERIZON-GEA-
01
Elimova E, Rha SY, Shitara K, Liu T,
Tabernero J, Lee KW, Schenker M,
Tebbutt NC, Ajani JA, Salimin N, Ku GY,
Kim JG, Diaz IA, Zhang J, Pietrantonio F,
Bai LY, Le Sourd SL, Chen Y, Grim JE,
Shen L
Type: Poster
Session: Poster Session –
Gastrointestinal Cancer-
Gastroesophageal, Pancreatic,
and Hepatobiliary
Date/Time: May 30, 2026, 9
a.m.-Noon CDT
Abstract number: 4042
Combining
zanidatamab,
FOLFOX, and
pembrolizumab as
first-line therapy for
HER2/PD-L1-positive
gastroesophageal
adenocarcinoma –
The phase ll IKF-
090/AIO ZANGEA trial
with translational
analysis
Tintelnot J, Goekkurt E, Al-Batran SE,
Arnold D, Dechow TN, Ettrich TJ, Goetze
TO, Heinrich K, Kurreck A, Lorenzen S,
Moehler MH, Rempel V, Schlenska-Lange
A, Stein A
Type: Poster
Session: Poster Session –
Gastrointestinal Cancer-
Gastroesophageal, Pancreatic,
and Hepatobiliary
Date/Time: May 30, 2026, 9
a.m.-Noon CDT
Abstract number: TPS4244
Zanidatamab +
chemotherapy (CT) ±
tislelizumab for first-
line (1L) HER2-
positive (HER2+)
locally advanced or
metastatic
gastroesophageal
adenocarcinoma
(mGEA): PD-L1
subgroup analysis
from HERIZON-GEA
-01
Rha SY, Shitara K, Shen L, Tabernero J,
Liu T, Lee KW, Schenker M, Tebbutt NC,
Ajani JA, Salimin N, Ku GY, Kim JG, Diaz
IA, Zhang J, Pietrantonio F, Bai LY, Sourd
SL, Chen Y, Grim JE, Elimova E
Type: Rapid Oral
Session: Rapid Oral Abstract
Session – Gastrointestinal
Cancer-Gastroesophageal,
Pancreatic, and Hepatobiliary
Date/Time: June 1, 2026, 1:15-2:45 p.m. CDT
Abstract number: 4010
Lurbinectedin Presentations:
Presentation Title
Authors
Presentation Details
Real-world (RW)
effectiveness and
safety of lurbinectedin
(lurbi) for previously
treated extensive-
stage small cell lung
cancer (ES-SCLC):
Final primary and
subgroup analysis
results of Jazz
EMERGE 402
Badin FB, Lammers PE, Liu G,
Shunyakov L, Kassam SN, Patel MP, Ji Y,
Labbé C, Rabara V, Hashmi MH, Dakhil
SR, Weiss M, Gowan AC, Bouchard N,
Rengarajan B, Fuller DS, Naveh N,
Halmos B
Type: Poster
Session: Poster Session –
Lung Cancer-Non-Small Cell
Local-Regional/Small Cell/Other
Thoracic Cancers
Date/Time: May 31, 2026, 9
a.m.-Noon CDT
Abstract number: 8079
Comparison of real-
world overall survival
between
atezolizumab- and
durvalumab-containing
first-line induction and
maintenance regimens
in extensive stage
small cell lung cancer
Ganti AK, Snider J, Yan J, Rinaldi C,
Nguyen A, Rengarajan B, Profant DA,
Fuller DS, Hu E, Le TK, Naveh N, Fan X
Type: Poster
Session: Poster Session –
Lung Cancer-Non-Small Cell
Local-Regional/Small Cell/Other
Thoracic Cancers
Date/Time: May 31, 2026, 9
a.m.-Noon CDT
Abstract number: 8093
IMforte: Quality
-adjusted time without
symptoms or toxicity
(Q-TWiST) analysis of
first-line maintenance
(1Lm) treatment (Tx)
with lurbinectedin
(lurbi) + atezolizumab
(atezo) vs atezo in
extensive-stage small
cell lung cancer (ES-
SCLC)
Borghaei H, Paz-Ares LG, Reck M, Herbst
RS, Peters S, Bhatt K, Wang X, Gable J,
Connor-Ahmad S, Mamolo C, Lin YC, Liu
SV
Type: Poster
Session: Poster Session –
Lung Cancer-Non-Small Cell
Local-Regional/Small Cell/Other
Thoracic Cancers
Date/Time: May 31, 2026, 9
a.m.-Noon CDT
Abstract number: 8086
Transcriptomic
analyses of molecular
subsets and
correlations with
clinical outcomes from
the Phase 3 IMforte
study of lurbinectedin
(lurbi) + atezolizumab
(atezo) maintenance
treatment (Tx) in
extensive-stage small-
cell lung cancer (ES-
SCLC)
Paz-Ares L, Borghaei H, Reck M, Peters
S, Herbst RS, Kazarnowicz A, Szczesna
A, Cubukcu E, Kilickap S, Ahn JS,
Califano R, Wei YF, Srivastava MK, Nabet
BY, Graupner V, Lin YC, Cai G, Brock G,
Bhatt K, Liu SV
Type: Rapid Oral
Session: Rapid Oral Abstract
Session – Lung Cancer-Non-
Small Cell Local-Regional/Small
Cell/Other Thoracic Cancers
Date/Time: May 31, 2026, 4:30-
6 p.m. CDT
Abstract number: 8014
Safety and
pharmacokinetics (PK)
of lurbinectedin (lurbi)
in pediatric patients
(pts) with
relapsed/refractory
(R/R) solid tumors and
preliminary antitumor
activity in pediatric and
young adult pts with
R/R Ewing sarcoma
(EwS): Results from a
phase 1 study
Glade Bender JL, Pressey JG, Wagner
LM, Kim AR, Shah AT, Federico SM,
Morgenstern DA, Hoogstra DJ, Crane J,
Bhatt K, Prakash R, Faderl S, Parikh P,
Daniels M, Shi S, Wang X, Cai G, Miao X,
Ma J, Laetsch TW
Type: Rapid Oral
Session: Rapid Oral Abstract
Session – Sarcoma
Date/Time: May 31, 2026, 4:30-
6 p.m. CDT
Abstract number: 11518
About Ziihera (zanidatamab-hrii)
Ziihera (zanidatamab-hrii) is a bispecific HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab-hrii with HER2 results in internalization leading to a reduction in HER2 expression of the receptor on the tumor cell surface. Zanidatamab-hrii induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC), and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.[1] In the United States, Ziihera is indicated for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.1 The FDA granted accelerated approval for this indication based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).1
Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz and BeOne under license agreements from Zymeworks, which first developed the molecule.
A supplemental biologics license application for zanidatamab was submitted to the FDA under Real-Time Oncology Review in first-line HER2+ locally advanced or metastatic GEA. The FDA granted two Breakthrough Therapy designations for zanidatamab’s development: one as a single agent for previously treated HER2 gene-amplified BTC, and one in combination with fluoropyrimidine- and platinum-containing chemotherapy, with or without tislelizumab for first-line HER2+ unresectable locally advanced or metastatic gastric, gastroesophageal junction (GEJ) or esophageal adenocarcinoma. The FDA also granted 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 the FDA for the treatment of BTC, gastric (including GEJ) cancer, and esophageal cancer, as well as Orphan Drug designations from the European Medicines Agency for the treatment of BTC, gastric/gastroesophageal junction cancer and oesophageal cancer.
Important Safety Information for ZIIHERA
WARNING: EMBRYO-FETAL TOXICITY
Exposure to ZIIHERA during pregnancy can cause embryo-fetal harm. Advise patients
of the risk and need for effective contraception.
WARNINGS AND PRECAUTIONS
Embryo-Fetal Toxicity
ZIIHERA can cause fetal harm when administered to a pregnant woman. In literature reports, use of a HER2-directed antibody during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death.
Verify the pregnancy status of females of reproductive potential prior to the initiation of ZIIHERA. Advise pregnant women and females of reproductive potential that exposure to ZIIHERA during pregnancy or within 4 months prior to conception can result in fetal harm. Advise females of reproductive potential to use effective contraception during treatment with ZIIHERA and for 4 months following the last dose of ZIIHERA.
Left Ventricular Dysfunction
ZIIHERA can cause decreases in left ventricular ejection fraction (LVEF). LVEF declined by >10% and decreased to <50% in 4.3% of 233 patients. Left ventricular dysfunction (LVD) leading to permanent discontinuation of ZIIHERA was reported in 0.9% of patients. The median time to first occurrence of LVD was 5.6 months (range: 1.6 to 18.7). LVD resolved in 70% of patients.
Assess LVEF prior to initiation of ZIIHERA and at regular intervals during treatment. Withhold dose or permanently discontinue ZIIHERA based on severity of adverse reactions.
The safety of ZIIHERA has not been established in patients with a baseline ejection fraction that is below 50%.
Infusion-Related Reactions
ZIIHERA can cause infusion-related reactions (IRRs). An IRR was reported in 31% of 233 patients treated with ZIIHERA as a single agent in clinical studies, including Grade 3 (0.4%), and Grade 2 (25%). IRRs leading to permanent discontinuation of ZIIHERA were reported in 0.4% of patients. IRRs occurred on the first day of dosing in 28% of patients; 97% of IRRs resolved within one day.
Prior to each dose of ZIIHERA, administer premedications to prevent potential IRRs. Monitor patients for signs and symptoms of IRR during ZIIHERA administration and as clinically indicated after completion of infusion. Have medications and emergency equipment to treat IRRs available for immediate use.
If an IRR occurs, slow, or stop the infusion, and administer appropriate medical management. Monitor patients until complete resolution of signs and symptoms before resuming. Permanently discontinue ZIIHERA in patients with recurrent severe or life-threatening IRRs.
Diarrhea
ZIIHERA can cause severe diarrhea.
Diarrhea was reported in 48% of 233 patients treated in clinical studies, including Grade 3 (6%) and Grade 2 (17%). If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Withhold or permanently discontinue ZIIHERA based on severity.
ADVERSE REACTIONS
Serious adverse reactions occurred in 53% of 80 patients with unresectable or metastatic HER2-positive BTC who received ZIIHERA. Serious adverse reactions in >2% of patients included biliary obstruction (15%), biliary tract infection (8%), sepsis (8%), pneumonia (5%), diarrhea (3.8%), gastric obstruction (3.8%), and fatigue (2.5%). A fatal adverse reaction of hepatic failure occurred in one patient who received ZIIHERA.
The most common adverse reactions in 80 patients with unresectable or metastatic HER2-positive BTC who received ZIIHERA (≥20%) were diarrhea (50%), infusion-related reaction (35%), abdominal pain (29%), and fatigue (24%).
USE IN SPECIFIC POPULATIONS
Pediatric Use
Safety and efficacy of ZIIHERA have not been established in pediatric patients.
Geriatric Use
Of the 80 patients who received ZIIHERA for unresectable or metastatic HER2-positive BTC, there were 39 (49%) patients 65 years of age and older. Thirty-seven (46%) were aged 65-74 years old and 2 (3%) were aged 75 years or older.
No overall differences in safety or efficacy were observed between these patients and younger adult patients.
The full U.S. Prescribing Information for ZIIHERA, including BOXED Warning, is available at: View Source
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 potentially cell death.2
In October 2025, the FDA approved Zepzelca in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs, as maintenance treatment for adults 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.
In June 2020, the FDA approved Zepzelca under accelerated approval for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. This indication is approved under accelerated approval based on ORR and DOR. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Important Safety Information for ZEPZELCA
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, the use of G-CSF is recommended. Withhold, reduce the dose, or permanently discontinue ZEPZELCA based on severity.
ZEPZELCA with Intravenous Atezolizumab
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.
ZEPZELCA as a Single Agent
In clinical studies of 554 patients with advanced solid tumors receiving ZEPZELCA as a single agent, Grade 3 or 4 neutropenia occurred in 41% of patients, with a median time to onset of 15 days and a median duration of 7 days. Febrile neutropenia occurred in 7% of patients. Sepsis occurred in 2% of patients and was fatal in 1% (all cases occurred in patients with solid tumors other than SCLC). Grade 3 or 4 thrombocytopenia occurred in 10%, with a median time to onset of 10 days and a median duration of 7 days. Grade 3 or 4 anemia occurred in 17% of patients.
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.
ZEPZELCA with Intravenous Atezolizumab
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).
ZEPZELCA as a Single Agent
In clinical studies of 554 patients with advanced solid tumors receiving ZEPZELCA as a single agent, Grade 3 elevations of ALT and AST were observed in 6% and 3% of patients, respectively, and Grade 4 elevations of ALT and AST were observed in 0.4% and 0.5% of patients, respectively. The median time to onset of Grade ≥3 elevation in transaminases was 8 days (range: 3 to 49), with a median duration of 7 days.
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.
ZEPZELCA with Intravenous Atezolizumab
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.
ZEPZELCA with Intravenous Atezolizumab
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 7 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
ZEPZELCA with Intravenous Atezolizumab
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%).
ZEPZELCA as a Single Agent
Serious adverse reactions occurred in 34% of patients who received ZEPZELCA. Serious adverse reactions in ≥3% of patients included pneumonia, febrile neutropenia, neutropenia, respiratory tract infection, anemia, dyspnea, and thrombocytopenia.
The most common adverse reactions, including laboratory abnormalities, (≥20%) are leukopenia (79%), lymphopenia (79%), fatigue (77%), anemia (74%), neutropenia (71%), increased creatinine (69%), increased alanine aminotransferase (66%), increased glucose (52%), thrombocytopenia (37%), nausea (37%), decreased appetite (33%), musculoskeletal pain (33%), decreased albumin (32%), constipation (31%), dyspnea (31%), decreased sodium (31%), increased aspartate aminotransferase (26%), vomiting (22%), decreased magnesium (22%), cough (20%), and diarrhea (20%).
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
ZEPZELCA with Intravenous Atezolizumab
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).
ZEPZELCA as a Single Agent
Of the 105 patients with SCLC administered ZEPZELCA in clinical studies, 37 (35%) patients were 65 years of age and older, while 9 (9%) patients were 75 years of age and older. No overall difference in effectiveness was observed between patients aged 65 and older and younger patients.
There was a higher incidence of serious adverse reactions in patients ≥65 years of age than in patients <65 years of age (49% vs. 26%, respectively). The serious adverse reactions most frequently reported in patients ≥65 years of age were related to myelosuppression and consisted of febrile neutropenia (11%), neutropenia (11%), thrombocytopenia (8%), and anemia (8%). There was a higher incidence of Grade 3 or 4 adverse reactions in patients ≥65 years of age compared to younger patients (76% vs. 50%, 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.
The full Prescribing Information for ZEPZELCA is available
at: View Source
Tevimbra (tislelizumab) is a registered trademark of BeOne Medicines.
Zepzelca a trademark of Pharma Mar, S.A. used by Jazz Pharmaceuticals under license.
Tecentriq (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.
(Press release, Jazz Pharmaceuticals, APR 21, 2026, View Source [SID1234664635])