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

Lurbinectedin with atezolizumab maintenance therapy in extensive-stage small-cell lung cancer. (PubMed, Lancet) - No abstract available

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

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

Zepzelca: “IMforte demonstrated a statistically significant and clinically meaningful improvement in IRF-PFS and OS with 1L maintenance treatment with lurbinectedin + atezolizumab vs atezolizumab in patients with ES-SCLC“; Small cell lung cancer (Jazz Pharma) - ASCO 2025

P3 data • Lung Cancer • Oncology • Small Cell Lung Cancer

Zepzelca (lurbinectedin) and Atezolizumab (Tecentriq) Combination Granted U.S. FDA Priority Review for First-Line Maintenance Treatment of Extensive-Stage Small Cell Lung Cancer (PRNewswire) - "Jazz Pharmaceuticals plc...announced the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for Zepzelca (lurbinectedin) in combination with atezolizumab (Tecentriq) as a first-line maintenance treatment for people with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin, and etoposide for Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of October 7, 2025....The sNDA submission is based on results from the Phase 3 IMforte trial of Zepzelca in combination with atezolizumab..."

FDA filing • PDUFA • Priority review • Small Cell Lung Cancer

Lurbinectedin for extensive stage - small cell lung cancer (ES-SCLC): real world response patterns and survival outcomes. (PubMed, Lung Cancer) - "Lurbinectedin demonstrated meaningful clinical activity in second-line therapy for SCLC, while also showing durable responses in heavily pretreated cases. These findings support the consideration of lurbinectedin also beyond second-line therapy in selected SCLC patients, though larger prospective studies are needed to validate these response patterns."

Journal • Real-world evidence • Hematological Disorders • Lung Cancer • Neutropenia • Oncology • Small Cell Lung Cancer • Solid Tumor • Thrombocytopenia

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

Pretreatment insights into primary sarcoma tissues using a novel approach of ex-vivo functional profiling to quantify cytotoxic and anti-proliferative effects of chemo and targeted therapies. (ASCO 2025) - "Background: Sarcoma treatment relies on doxorubicin- or ifosfamide-based regimens, or combinations like gemcitabine and docetaxel...While drugs like gemcitabine, sorafenib, and sunitinib were presumed to be more cytostatic, and platinum agents, actinomycin, and lurbinectedin were presumed more cytotoxic, actual ratios of those EC50 responses varied widely... This is the first study systematically comparing ex vivo anti-proliferative and cytotoxic profiles in live sarcoma tissues. Conventional chemosensitivity assays focusing on just one endpoint may oversimplify treatment decisions, whereas multi-dimensional functional profiling offers a more rational approach to personalized sarcoma therapy. Standardized EC50 for cytotoxicity and antiproliferation for NCCN guideline recommended therapies."

Preclinical • Oncology • Sarcoma • Solid Tumor

Real-world effectiveness of lurbinectedin in extensive stage small cell lung cancer (ES-SCLC). (ASCO 2025) - "Before the recent approval of Tarlatamab-dlle, National Comprehensive Cancer Network (NCCN) guidelines recommended Lurbinectedin for subsequent systemic therapy if the chemotherapy free interval is less than or equal to 6 months with the only other options being topotecan and irinotecan. In our real-world analysis, lurbinectedin demonstrated good activity as a single agent in the second line treatment of ES-SCLC with an OS rate of 68.3% at 1 year and 37.4% at 3 years. If the median TTD can be considered a potential surrogate for progression free survival (PFS), then we would have a PFS of 3 months which is slightly shorter in our cohort compared to 3.5 months reported by Trigo et al in their original paper. Retrospective nature of the study and lack of control group, however, limit the predictor variables."

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Lurbinectedin for small cell lung cancer (SCLC): Response patterns and survival outcomes by line of therapy. (ASCO 2025) - "Lurbinectedin demonstrated meaningful clinical activity in second-line therapy for SCLC, while also showing durable responses in heavily pretreated cases. These findings support the consideration of lurbinectedin beyond second-line therapy in selected SCLC patients, though larger prospective studies are needed to validate these response patterns."

Anemia • Lung Cancer • Neutropenia • Oncology • Small Cell Lung Cancer • Solid Tumor • Thrombocytopenia

Lurbinectedin with immunotherapy in extensive-stage small cell lung cancer: Current insights and future prospects—A systematic review. (ASCO 2025) - P1/2, P2 | " A total of 54 patients from two studies investigating the role of LUR in combination with pembrolizumab and atezolizumab (ATZ) were included in this systematic review...Three ongoing trials (NCT04607954, NCT04253145, NCT06497530), including 230 recruiting patients and 30 not yet recruiting patients, are going to explore LUR combination with durvalumab, ATZ, and sarilumab, respectively. LUR-IO shows promising efficacy and manageable safety profiles in extensive-stage small-cell lung cancer. However, further results from ongoing trials are essential to understand its long-term potential and broader applicability better."

Review • Anemia • Febrile Neutropenia • Lung Cancer • Neutropenia • Oncology • Small Cell Lung Cancer • Solid Tumor

Evaluation of the combination of lurbinectedin and atezolizumab in a humanized mouse model. (ASCO 2025) - "In syngeneic SCLC mouse models, it effectively reverses resistance to first-line Pt-etoposide-anti-PD-L1 therapy when combined with anti-PD-L1, emulating clinical treatment scenarios. Humanized NXG-HIS mice were developed using busulfan chemoablation and CD34+ cord blood cell transplantation... Lurbinectedin directly targets tumors by blocking their transcriptional profile, recruiting anti-tumoral immune cells, and enhancing tumor antigenicity. Consequently, it mitigates tumor immune evasion, "warming" the immune tumor microenvironment and sensitizing to atezolizumab treatment in combination."

IO biomarker • Preclinical • Breast Cancer • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CD34 • CD8

Comparison of outcomes for patients diagnosed with small cell lung cancer between a university and safety net hospital. (ASCO 2025) - "At data cut-off, no difference was found between UH and SNH for use of lurbinectedin (15.8% vs 8%, P = .16) or tarlatamab (3.6% vs 2%, P = 1). Patient at UH were found to have shorter CTFI with first line chemoimmunotherapy. This difference may reflect the referral patterns for patients with complex SCLC presentations to an academic cancer center. More SDH was identified at UH."

Clinical • 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

Tarlatamab versus chemotherapy (CTx) as second-line (2L) treatment for small cell lung cancer (SCLC): Primary analysis of Ph3 DeLLphi-304. (ASCO 2025) - P3 | "The DeLLphi-304 trial showed tarlatamab significantly improved OS, PFS, and PROs, with a favorable safety and tolerability profile compared to CTx in pts with SCLC that progressed on or after initial platinum-based CTx, defining a new standard of care for these patients. Clinical Trial Information: NCT05740566; Legal entity responsible: Amgen Inc.; Funding: Amgen Inc.; Editorial acknowledgement: Medical writing support for the development of this abstract was provided by Sukanya Raghuraman, PhD, of Cactus Life Sciences, part of Cactus Communications, and was funded by Amgen Inc. MD: mean difference; NE: not estimable; wks, weeks.*Topotecan (n=185), lurbinectedin (n=47), or amrubicin (n=23).†EORTC QLQ-C30 scale.‡EORTC QLQ-LC13 scale.§Non-significant."

Clinical • Late-breaking abstract • Anemia • Cough • Lung Cancer • Neutropenia • Oncology • Pulmonary Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor

Safety and efficacy of lurbinectedin plus atezolizumab as second-line treatment for advanced small-cell lung cancer: Results of the 2SMALL phase 1/2 study (NCT04253145). (ASCO 2025) - P1/2, P3 | "The combination of LUR and ATZ showed promising efficacy in patients with relapsed SCLC regardless of prior exposure to immunotherapy, including those with resistance to platinum. The associated safety profile is manageable. The regimen is being evaluated in a phase III trial in the maintenance setting (IMforte trial NCT05091567)."

Clinical • Metastases • P1/2 data • Febrile Neutropenia • Lung Cancer • Neutropenia • Oncology • Small Cell Lung Cancer • Solid Tumor • Thrombocytopenia

LUPER: Lurbinectedin (PM01183) Combined With Pembrolizumab in Small Cell Lung Cancer. (clinicaltrials.gov) - P1/2 | N=28 | Completed | Sponsor: Antonio Calles Blanco | Active, not recruiting ➔ Completed

Trial completion • Lung Cancer • Neutropenia • Oncology • Small Cell Lung Cancer • Solid Tumor

Jazz Pharmaceuticals Announces Zepzelca (lurbinectedin) and Atezolizumab (Tecentriq) Combination Significantly Improves Survival as First-Line Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer (PRNewswire) - P3 | N=660 | IMforte (NCT05091567) | Sponsor: Hoffmann-La Roche | "The study met both primary endpoints, demonstrating statistically significant improvements in progression-free survival (PFS) and overall survival (OS) compared to atezolizumab alone....The data were presented today in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting....483 patients were randomized after completion of 4 cycles of induction therapy with atezolizumab plus carboplatin and etoposide. From the point of randomization, the median OS for the Zepzelca plus atezolizumab regimen was 13.2 months versus 10.6 months for atezolizumab alone (stratified hazard ratio [HR] = 0.73; 95% CI: 0.57–0.95; p = 0.0174). From the point of randomization, the median PFS by independent assessment was 5.4 months versus 2.1 months, respectively (stratified HR = 0.54, 95% CI: 0.43–0.67; p < 0.0001)."

P3 data • Small Cell Lung Cancer

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

Early Access Program in oncology: Retrospective study at a Portuguese hospital (ECOP 2024) - "During the study period were submitted 163 EAP requests for abiraterone, amivantamab, bevacizumab, durvalumab, encorafenib, enfortumab, everolimus, erdafitinib, lenvatinib, lurbinectedin, niraparib, nivolumab, olaparib, pembrolizumab, pertuzumab, ramucirumab, sacituzumab govitecan, selpercatinib, trifluridine/tipiracil, trametinib+dabrafenib, trastuzumab-deruxtecan and tucatinib. Conclusion Most cases correspond to metastatic disease, EAPs facilitate timely access to innovative therapies for patients with high unmet medical needs. The majority of situations were financed, which confirms the importance of EAPs in an era where oncology is constantly innovating."

Retrospective data • Gastrointestinal Disorder • Oncology

Patient Characteristics and Treatment Patterns in Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (ISPOR 2025) - "After 1L therapy, subsequent options include lurbinectedin, topotecan, platinum rechallenge (PR), and tarlatamab (since 2024). ES-SCLC patients receiving 1Lm and subsequent therapy tend to be younger and healthier than the average patients receiving 1L treatment. Lurbinectedin was the most common 2L and 3L treatment. Reasons for not proceeding with treatment intensification in 1L and 1Lm should be further investigated."

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

DeLLphi-304: Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=509 | Active, not recruiting | Sponsor: Amgen | Trial primary completion date: Jul 2027 ➔ Jan 2025

Trial primary completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Real-world use, effectiveness, and safety of second-line lurbinectedin monotherapy in small cell lung cancer. (PubMed, Future Oncol) - "Lurbinectedin-treated patients reported less grade ≥3 thrombocytopenia (11.7%) and anemia (6.5%) versus OST (27.2% and 20.3%, respectively); prevalence by CTFI status were similar. Lurbinectedin demonstrated comparable real-world effectiveness with OST with a favorable safety profile; however, these findings are limited by small sample size."

Journal • Monotherapy • Real-world evidence • Hematological Disorders • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Thrombocytopenia

Lurbinectedin-induced Pneumonitis and DAH in Recurrent Stage IV SCLC: Possible Pulmonary Toxicity From a Novel Alkylating Agent (ATS 2025) - "He was initiated on empiric antibiotics, stress-dose steroids, and IV Lasix; oxygen requirement increased to 35% FiO2 via venti-mask. Lurbinectedin has become a preferable second-line option in recurrent stage IV SCLC due to its favorable side-effect profile and non-inferior efficacy, particularly in the elderly population1,5,7. As its use become increasingly common, more investigation is needed to further explore this novel drug's potential pulmonary toxicity14."

Metastases • Inflammation • Lung Cancer • Oncology • Pneumonia • Small Cell Lung Cancer • Solid Tumor

Jazz Pharmaceuticals Announces First Quarter 2025 Financial Results and Updates 2025 Financial Guidance (PRNewswire) - "Key Highlights: Submitted sNDA for Zepzelca in combination with atezolizumab (Tecentriq) as maintenance therapy in 1L ES-SCLC based on the potentially practice-changing results from the Phase 3 IMforte trial. Data from trial to be presented at the 2025 ASCO Annual Meeting in June 2025; Acquisition of Chimerix added dordaviprone to late-stage pipeline, representing near-term commercial opportunity; PDUFA target data of August 18, 2025...Commercial Updates: (i) Rylaze/Enrylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn): Rylaze/Enrylaze net product sales decreased 8% to $94.2 million in 1Q25 compared to 1Q24. This decrease was driven by headwinds from an update to Children's Oncology Group (COG) pediatric treatment protocols for acute lymphoblastic leukemia made in mid-2024 that impacted timing of asparaginase administration."

FDA filing • PDUFA • Sales • Acute Lymphocytic Leukemia • Diffuse Glioma • Small Cell Lung Cancer

First-Line Maintenance Lurbinectedin Plus Atezolizumab Boosts Survival in ES-SCLC (OncLive) - P3 | N=660 | IMforte (NCT05091567) | Sponsor: Hoffmann-La Roche | "Frontline maintenance treatment with lurbinectedin (Zepzelca) plus atezolizumab (Tecentriq) improved progression-free survival (PFS) and overall survival (OS) vs atezolizumab alone in patients with extensive-stage small cell lung cancer (ES-SCLC), according to primary results from the phase 3 IMforte trial (NCT05091567) presented at the 2025 ASCO Annual Meeting. The median PFS with the doublet (n = 242) was 5.4 months (95% CI, 4.2-5.8) by independent review facility (IRF) assessment vs 2.1 months (95% CI, 1.6-2.7) with the monotherapy (n = 241), translating to a 46% reduction in the risk of disease progression or death (HR, 0.54; 95% CI, 0.43-0.67; 2-sided P < .0001). The 6-month IRF-PFS rates in the respective arms were 41.2% and 18.7%; at 12 months, these rates were 20.5% and 12.0%."

P3 data • Small Cell Lung Cancer