Zepzelca (lurbinectedin) / Boryung Group, PharmaMar, Jazz, Luye Group, Key Oncologics, Specialised Therap, EMD Serono - LARVOL DELTA

First-Line Maintenance With Serplulimab for Extensive-Stage Small Cell Lung Cancer: A Post-Hoc Analysis and Meta-Analysis (IASLC-WCLC 2026) - "As shown in Table 1, compared with atezolizumab, serplulimab was associated with more favorable OS (hazard ratio [HR], 0.63; 95% CI, 0.48-0.81) and PFS (HR, 0.62; 95% CI, 0.49-0.80); compared with atezolizumab plus lurbinectedin, serplulimab was associated with improved OS (HR, 0.74; 95% CI, 0.57-0.97), similar PFS (HR, 1.01; 95% CI, 0.77-1.31), and an approximately 50% lower risk of grade ≥3 TRAEs (risk ratio, 0.52; 95% CI, 0.38-0.72). Conclusions : In this inter-study comparison, serplulimab was associated with more favorable OS and PFS than atezolizumab and with more favorable OS and safety than atezolizumab plus lurbinectedin."

Retrospective data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Efficacy and Safety of ABBV-706 Versus Standard of Care in Relapsed/Refractory Small Cell Lung Cancer: A Phase 3 Study (IASLC-WCLC 2026) - P1, P3 | "Tarlatamab, a recommended standard of care (SOC) in second line (2L) for patients with ES-SCLC with disease progression on or after platinum-based chemotherapy, offers improved response rates in heavily treated relapsed/refractory (R/R) patients; however, treatment options in this setting are still limited...Methods : M23-384 (NCT07365241) is a Phase 3, global, randomized, open-label, multicenter (~175 sites) study, evaluating the safety and efficacy of ABBV-706 versus SOC (topotecan, lurbinectedin, or amrubicin) in patients with R/R SCLC...Key secondary endpoints include progression-free survival and duration of response based on BICR assessment per RECIST v1.1, patient-reported outcomes (change from baseline at Week 12 in physical functioning as measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 [EORTC QLQ-C30], and in Global Health Status [GHS]/QoL as measured by the EORTC QLQ-C30 GHS/QoL scale), and..."

Clinical • First-in-human • P3 data • CNS Disorders • Epilepsy • Interstitial Lung Disease • Lung Cancer • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor • SEZ6

Lurbinectedin plus irinotecan in pretreated gastroenteropancreatic neuroendocrine neoplasms: results of a phase II expansion cohort. (PubMed, ESMO Open) - P1/2 | "The combination of lurbinectedin plus irinotecan with primary granulocyte colony-stimulating factor prophylaxis showed antitumor activity in GEP-NECs but limited activity in GEP-NETs. This combination had a predictable and manageable safety profile, with myelosuppression, gastrointestinal disorders, and fatigue as main toxicities. The lurbinectedin plus irinotecan combination deserves to be further explored in GEP-NECs after failure of platinum therapy."

Journal • P2 data • Endocrine Cancer • Fatigue • Febrile Neutropenia • Gastroenterology • Gastrointestinal Disorder • Gastrointestinal Neuroendocrine Carcinoma • Gastrointestinal Neuroendocrine Tumor • Hematological Disorders • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Neutropenia • Oncology • Pancreatic Cancer • Solid Tumor

MHRA approves lurbinectedin for adults with extensive-stage small cell lung cancer (GOV.UK) - "The medicine is given as an intravenous infusion over one hour. The recommended dose is administered once every 21 days. Treatment should be started and supervised in a hospital or clinic by a healthcare professional....This approval was based on a main study involving 483 adults with extensive-stage SCLC."

MHRA approval • Small Cell Lung Cancer

Adding lurbinectedin to maintenance therapy improves outcomes in ES-SCLC. (PubMed, Nat Rev Clin Oncol) - No abstract available

Journal • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Combination lurbinectedin and doxorubicin versus physician's choice of chemotherapy in patients with relapsed small-cell lung cancer (ATLANTIS): a multicentre, randomised, open-label, phase 3 trial. (PubMed, Lancet Respir Med) - P3 | "Combination therapy with lurbinectedin plus doxorubicin did not improve overall survival versus control in patients with relapsed SCLC. However, lurbinectedin plus doxorubicin showed a favourable haematological safety profile compared with control."

Journal • P3 data • Hematological Disorders • Lung Cancer • Neuroendocrine Tumor • Neutropenia • Oncology • Small Cell Lung Cancer • Solid Tumor • Thrombocytopenia

Flat-Dose Lurbinectedin Plus Serplulimab as First-Line Maintenance Therapy in Chinese Patients with Extensive-Stage Small-Cell Lung Cancer: An Exploratory Study (ESMO 2026) - No abstract available

Clinical • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

ES03. Clinical Dilemmas in SCLC: Debating the Optimal Use of Novel Agents (Interactive Session) (IASLC-WCLC 2026) - "We will tackle the controversies surrounding novel agents, specifically debating the optimal placement of lurbinectedin (first-line vs. second-line) and assessing whether the era of Antibody-Drug Conjugates (ADCs) has truly arrived. Woven into these discussions will be the essential perspectives of both physicians and patients/caregivers, aiming to equip the audience with a clearer framework for treatment sequencing and shared decision-making."

Clinical • Lung Cancer • Small Cell Lung Cancer • Solid Tumor

Tarlatamab as second-line (2L) treatment for small cell lung cancer (SCLC): Outcomes by chemotherapy-free interval (CFI) and prior PD-(L)1 inhibitor use in the phase III DeLLphi-304 trial (ESMO 2025) - P3 | "Methods Patients were randomised 1:1 to tarlatamab or CTx (topotecan, lurbinectedin, or amrubicin) Post hoc analysis was conducted for prespecified subgroups based on CFI (< 90 vs ≥ 90 days) and prior anti-PD-(L)1 use (yes vs no). Additionally, in contrast to CTx, the reduced risk of death and higher ORR with tarlatamab remained consistent even in platinum-resistant disease where prognosis has been especially poor, reinforcing tarlatamab as a standard of care for 2L SCLC. Table: LBA101 CFI Tarlatamab CTx Tarlatamab CTx < 90 days ≥ 90 days Efficacy n = 109 n = 114 n = 145 n = 141 Median OS, mos 10.9 6.4 17.1 10.6 HR (95% CI) 0.60 (0.43, 0.84) 0.65 (0.45, 0.93) Median PFS, mos 3.2 2.7 4.5 4.4 HR (95% CI) 0.71 (0.54, 0.94) 0.73 (0.56, 0.95) Safety n = 107 n = 109 n = 145 n = 135 Grade ≥ 3 TRAEs, % 30 58 24 66 TRAE leading to dose interruption or reduction, % 21 50 18 59 CRS, % 59 - 54 - Prior PD-(L)1 Yes No Efficacy n = 180 n = 180 n = 74 n = 75 Median OS, mos..."

Clinical • Late-breaking abstract • P3 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Ultramutagenesis through Combined Msh2 Depletion and Proofreading-Deficient DNA Polymerase ε Expression Enhances Small-Molecule Target Identification in Forward Genetic Screens. (PubMed, ACS Chem Biol) - "Here, we combine auxin-inducible degradation of Msh2 with doxycycline-inducible expression of the proofreading-deficient PolεP286R mutant in murine small cell lung cancer (SCLC) cells. Simultaneous MMR deficiency and mutant Polε expression markedly increased the emergence of bortezomib-resistant clones relative to either perturbation alone, and targeted sequencing of Psmb5 in bortezomib-resistant clones identified recurrent mutations previously reported in resistance screens using MMR-deficient cells and chemical mutagenesis...Whole-exome sequencing revealed recurrent loss-of-function alterations in nucleotide excision repair (NER) genes, most notably Ercc5 and Ercc4, implicating NER deficiency as a major mechanism of lurbinectedin resistance and supporting a central role for NER in mediating lurbinectedin-induced cytotoxicity. Collectively, these findings establish inducible ultramutagenesis as a powerful and versatile platform for the unbiased discovery of drug..."

Journal • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • ERCC4 • ERCC5 • MSH2 • PSMB5

Debate 1: Lurbinectedin: Best to Use As 2nd Line Therapy? (IASLC-WCLC 2026) - No abstract available

Lung Cancer • Small Cell Lung Cancer • Solid Tumor

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. (PubMed, Lancet) - P3 | "IRF progression-free survival and overall survival were longer in the lurbinectedin plus atezolizumab group than the atezolizumab group for patients with ES-SCLC, albeit with a higher incidence of adverse events. Lurbinectedin plus atezolizumab represents a novel therapeutic option for first-line maintenance treatment in this setting."

Journal • P3 data • Cardiovascular • Heart Failure • Hematological Disorders • Infectious Disease • Leukopenia • Lung Cancer • Neutropenia • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor

Satellite Symposium 3 (SL03) Lurbinectedin in SCLC: The earlier, the longer, the better (KSMO 2026) - "Sponsored by Boryung"

Lung Cancer • Small Cell Lung Cancer • Solid Tumor

Tarlatamab in Small-Cell Lung Cancer after Platinum-Based Chemotherapy. (PubMed, N Engl J Med) - P3 | "Treatment with tarlatamab led to longer overall survival than chemotherapy among patients with small-cell lung cancer whose disease had progressed during or after platinum-based chemotherapy. (Funded by Amgen; DeLLphi-304 ClinicalTrials.gov number, NCT05740566.)."

Journal • Cough • Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor

Detailed safety analysis of DeLLphi-304: The first phase III study to evaluate tarlatamab versus chemotherapy for previously treated small cell lung cancer (ESMO 2025) - P3 | "Methods Pts were randomized to tarlatamab or chemotherapy (CTx: topotecan, lurbinectedin, or amrubicin). Conclusions In the DeLLphi-304 trial, tarlatamab demonstrated a predictable and manageable safety profile in 2L SCLC, with no new safety signals identified. Table: LBA100 Treatment-related adverse events TRAE Tarlatamab (n = 252) CTx (n = 244) All Grades Grade ≥3 All Grades Grade ≥3 Anemia 19.8% 2.0% 61.5% 27.9% Neutropenia 7.5% 4.4% 29.5% 22.1% Thrombocytopenia 3.2% 0.4% 23.8% 11.8% Infection 6.3% 1.2% 15.2% 8.6%"

Clinical • Late-breaking abstract • P3 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Thoracic Cancer • DLL3

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. (ASCO 2026) - P1/2 | "Lurbi is a trabectedin analogue that alkylates DNA and blocks transcription of EWS-FLI1, a primary driver of EwS. Based on these data, lurbi had a manageable safety profile, predictable PK properties, and encouraging preliminary clinical activity in pts with R/R EwS. Phase 2 expansion in pts ≤30 y with R/R EwS is ongoing. TRAEs in all pts and by dose."

Clinical • P1 data • PK/PD data • Acute Kidney Injury • Ewing Sarcoma • Nephrology • Oncology • Osteosarcoma • Pediatrics • Renal Disease • Respiratory Diseases • Sarcoma • Solid Tumor • EWSR1 • FLI1

Patterns of disease progression (PD) and efficacy associated with tumour burden from the phase III IMforte study of lurbinectedin (lurbi) + atezolizumab (atezo) as first-line (1L) maintenance treatment (tx) in ES-SCLC (ESMO 2025) - P3 | "Methods Eligible pts with ES-SCLC without PD after 1L induction tx with atezo, carboplatin, and etoposide were randomised 1:1 to maintenance tx q3w with lurbi 3.2 mg/m 2 + atezo 1200 mg or atezo until PD or unacceptable toxicity. Table: 2762MO Association of OS and IRF-PFS with maintenance BL tumour burden OS IRF-PFS Lurbi + atezo Atezo Lurbi + atezo Atezo Non-measurable disease only, n 67 59 67 59 Median, mo 16.4 12.2 7.3 2.8 Unstratified HR (95% CI) 0.75 (0.44, 1.28) 0.56 (0.36, 0.86) Measurable disease with baseline SOD <median, n 89 86 89 86 Median, mo 13.2 13.6 5.5 2.4 Unstratified HR (95% CI) 0.96 (0.62, 1.47) 0.58 (0.41, 0.82) Measurable disease with baseline SOD ≥median, n 86 96 86 96 Median, mo 11.7 8.6 4.2 1.6 Unstratified HR (95% CI) 0.59 (0.40, 0.86) 0.52 (0.37, 0.72) Conclusions Proportionately fewer IRF-defined PD events were observed in target/non-target lesions in the lurbi + atezo vs atezo arms. The addition of lurbi led to greater OS improvement..."

Clinical • P3 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Prospective, Exploratory Study of Lurbinectedin combined with Atezolizumab with or without Anlotinib as Second-line Therapy for Extensive-Stage Small Cell Lung Cancer (ChiCTR) - P=N/A | N=40 | Not yet recruiting | Sponsor: The First Affiliated Hospital,Sun Yat-sen University; The First Affiliated Hospital,Sun Yat-sen University

New trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Real-world effectiveness and safety of lurbinectedin monotherapy in relapsed small cell lung cancer: A systematic review and single-arm meta-analysis (ESMO 2026) - No abstract available

Monotherapy • Real-world • Real-world effectiveness • Real-world evidence • Retrospective data • Review • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Lurbinectedin, a selective inhibitor of oncogenic transcription, in patients with pretreated germline BRCA1/2 metastatic breast cancer: results from a phase II basket study. (PubMed, ESMO Open) - P2 | "This phase II study met its primary endpoint and showed activity of lurbinectedin in germline BRCA1/2 breast cancer. Lurbinectedin showed a predictable and manageable safety profile. Considering the exploratory aim of this trial as well as previous results in other phase II studies, further development of lurbinectedin in this indication is warranted."

Journal • P2 data • Pan tumor • Breast Cancer • Fatigue • Febrile Neutropenia • Hematological Disorders • Hormone Receptor Breast Cancer • Neutropenia • Oncology • Solid Tumor • BRCA • BRCA1 • BRCA2 • HER-2 • HRD

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). (ASCO 2026) - P3 | "Clinical outcomes in the 303 pts (median [m] PFS: 5.5 vs 2.4 months [mo], hazard ratio [HR] 0.61; mOS: 13.5 vs 11.7 mo, HR 0.72, for lurbi + atezo [n = 150] vs atezo [n = 153], respectively) were consistent with the full analysis set. The prevalence of the 4 SCLC subtypes and the TAM/T-eff pre-Tx data for IMforte are consistent with findings from IMpower133. PFS and OS were longer for lurbi + atezo vs atezo irrespective of molecular subset, though numerical trends suggest that lurbi may overcome TAM-mediated resistance to atezo."

Clinical • Clinical data • IO biomarker • P3 data • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • SLFN11

Phase 1 trial of ZL-1310, a DLL3-targeted ADC, in patients with previously treated extensive-stage small cell lung cancer (AACR-NCI-EORTC 2025) - P1 | "All pts had prior platinum-based chemotherapy, of whom 90.4% received a prior anti-PD‑L1, 13 (12.5%) had prior lurbinectedin, and 10 (9.6%) had a prior DLL3-targeted therapy. ZL-1310 has a manageable safety profile, encouraging activity, and displayed meaningful improvements in pts with CNS disease, addressing a critical unmet need – including in those with asymptomatic, untreated brain metastases. These data support further clinical development of ZL-1310 in SCLC."

Clinical • Late-breaking abstract • P1 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Jazz Pharmaceuticals | Initiation date: Aug 2026 ➔ Nov 2026

Trial initiation date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

LUPINE: Lurbinectedin Plus Paclitaxel Versus Paclitaxel in Patients With Previously Treated Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=69 | Not yet recruiting | Sponsor: Yonsei University | Initiation date: Jun 2026 ➔ Nov 2026

Trial initiation date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Lurbinectedin (lurbi) + atezolizumab (atezo) as first-line (1L) maintenance treatment (tx) in patients (pts) with extensive-stage small cell lung cancer (ES-SCLC): Primary results of the phase 3 IMforte trial. (ASCO 2025) - P3 | " Tx-naive pts with ES-SCLC received standard induction tx with atezo, carboplatin, and etoposide for four 21-day cycles (q3w). IMforte met both primary endpoints of IRF-PFS and OS, demonstrating a clinically meaningful benefit with 1L maintenance tx with lurbi + atezo vs atezo in pts with ES-SCLC. Lurbi + atezo was generally well tolerated, with no new or unexpected safety signals. IMforte is the first global Phase 3 study to show PFS and OS improvement with 1L maintenance tx for ES-SCLC and supports maintenance lurbi + atezo as a new option for pts with this aggressive disease."

Clinical • P3 data • Febrile Neutropenia • Infectious Disease • Lung Cancer • Neutropenia • Oncology • Septic Shock • Small Cell Lung Cancer • Solid Tumor