Lurbinectedin Efficacy and Safety in Small Cell Lung Cancer
Lurbinectedin Shows real-World Efficacy in Relapsed Small Cell lung Cancer, But Suboptimal Outcomes Persist for Certain Patient groups
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New real-world data published in the European Journal of Cancer offers insights into the effectiveness and safety of lurbinectedin for patients with relapsed small cell lung cancer (SCLC), highlighting areas of success and persistent challenges.
Real-World effectiveness and Safety of Lurbinectedin in ES-SCLC
A recent retrospective study, led by daniela Scattolin from the Veneto Institute of oncology IOV-IRCCS, Padova, Italy, investigated the outcomes of patients with extensive-stage small cell lung cancer (ES-SCLC) treated with lurbinectedin as compassionate use therapy. The study, published online on July 02, 2025, in the European Journal of Cancer, aimed to provide valuable real-world insights into the drug’s performance and safety profile.
The median follow-up duration for the study cohort was 5.53 months. Lurbinectedin was administered as second-line therapy in 37% of patients, as third-line therapy in 45%, and as further-line therapy in 18% of the participants.
Key Efficacy Findings
The study reported an objective response rate (ORR) of 23.1%, with a disease control rate (DCR) of 45.4%. These figures indicate that nearly half of the patients experienced some level of tumor shrinkage or stabilization with lurbinectedin treatment.
The median progression-free survival (PFS) was 2.2 months, and the median overall survival (OS) was 5.4 months. The 6-month PFS rate was 12.2%, while the 6-month OS rate stood at 42.4%. These survival metrics provide a benchmark for lurbinectedin’s impact in this challenging patient population.
Factors Influencing Outcomes
A notable finding of the study was the impact of the chemotherapy-free interval (CFI). Patients who had a CFI of 90 days or more demonstrated substantially longer PFS (3.1 months) and OS (6.8 months) compared to chemoresistant patients (PFS: 1.8 months; OS: 4.5 months). The hazard ratios were 0.46 for PFS (P < .001) and 0.56 for OS (P = .006),underscoring the importance of a longer break from prior chemotherapy. conversely, certain patient characteristics were associated with poorer outcomes. An Eastern Cooperative Oncology Group (ECOG) performance status of two or more at the start of lurbinectedin treatment, as well as the presence of brain or liver metastases, were identified as predictors of worse survival.
Safety Profile
The safety profile of lurbinectedin was also evaluated. Treatment-related adverse events (AEs) of any grade were reported in a high percentage of patients, with 92% experiencing at least one AE. Grade 3-4 toxicities were observed in 29% of patients. The most frequent severe AE was neutropenia,which occurred in 22% of the patients.
The authors of the study emphasize the value of these real-world insights for clinical practice. “Our study provides valuable real-world insights into the effectiveness and safety of lurbinectedin as compassionate use treatment for ES-SCLC, supporting its use with outcomes consistent with those observed in clinical trials and other real-world studies,” they stated.
However, they also caution that outcomes for specific patient subgroups remain suboptimal. “Patients with poor PS [performance status] at lurbinectedin start, a CFI [chemotherapy-free interval] of less than 90 days, and brain or liver metastases remain suboptimal and this should be carefully considered when making treatment decisions,” the authors advised. This highlights the need for careful patient selection and management when considering lurbinectedin for relapsed ES-SCLC.
Study Limitations and Future directions
The researchers acknowledge several limitations inherent in the study’s design. These include its retrospective nature,the relatively small number of participating centers,and imbalanced cohort sizes across different countries. Heterogeneity in baseline patient characteristics, treatment management strategies, and tumor assessment protocols were also noted. Furthermore, variations in national regulations concerning chemoimmunotherapy use could have introduced bias. The retrospective data collection method may have also led to an underreporting of adverse events.