Real-World Study Demonstrates Clinical Activity of Lurbinectedin in Previously Treated Small Cell Lung Cancer

Clinical Summary:

• Design/Population: The observational, phase 4 Jazz EMERGE 402 trial evaluated real-world effectiveness and safety of lurbinectedin in patients with previously treated extensive-stage small cell lung cancer (ES-SCLC) receiving care across the United States and Canada. 
• Key Outcomes: Lurbinectedin demonstrated an objective response rate of 29% among 189 response-evaluable patients, with a median progression-free survival of 3.3 months and median overall survival of 7.6 months. Baseline CNS metastases were associated with lower response, while platinum resistance was associated with shorter overall survival. 
• Clinical Relevance: These findings provide prospective real-world evidence supporting the activity of lurbinectedin in previously treated patients with relapsed SCLC, including patients with poor prognostic characteristics, while highlighting the importance of CNS involvement and platinum sensitivity when evaluating treatment outcomes. 

According to results from the phase 4 Jazz EMERGE 402 study, lurbinectedin demonstrated clinically meaningful real-world antitumor activity in patients with previously treated small-cell lung cancer (SCLC), while identifying baseline central nervous system (CNS) metastases and platinum-resistant disease as factors associated with poorer treatment outcomes. 

“In extensive-stage SCLC, lurbinectedin is approved for first-line maintenance treatment with atezolizumab and as monotherapy following disease progression, but prospective real-world data on its use are lacking,” stated Firas Badin, MD, Baptist Health Medical Group, Lexington, Kentucky, and coauthors. 

In this prospective, observational trial, 267 patients with previously treated extensive-stage SCLC received at least 1 dose of lurbinectedin across more than 50 centers in the United States and Canada. The study evaluated lurbinectedin in a real-world population that included patients with poor prognostic characteristics, such as CNS metastases, platinum-resistant disease, and reduced performance status.

The primary end point was investigator-assessed objective response rate (ORR). Key secondary end points included progression-free survival (PFS), overall survival (OS), duration of response, disease control rate, and safety.

Lurbinectedin was administered as second-line treatment in 169 patients, third-line treatment in 78 patients, and fourth-line or later treatment in 20 patients. Two patients receiving second-line treatment received lurbinectedin in combination with bevacizumab. 

 At analysis, the ORR among 189 evaluable patients with measurable disease evaluable by RECIST version 1.1 was 29%. Complete responses occurred in 4% of patients, while partial responses were reported in 25% of patients. The disease control rate was 49% and the median duration of response was 3.9 months. 

Among 118 response-evaluable patients receiving second-line lurbinectedin, the ORR was 33%, compared with 24% in 58 patients receiving third-line treatment. 

Median PFS in the response-evaluable population was 3.3 months, with estimated PFS rates of 24% at 6 months and 9% at 9 months. Median OS in the overall study population was 7.6 months. 

Subgroup analyses identified baseline CNS metastases as a factor associated with reduced antitumor activity. Among response-evaluable patients, the ORR was 17% in those with CNS metastases and 32% in those without CNS involvement. 

Median PFS was 2.8 months in patients with baseline CNS metastases and 3.8 months in patients without CNS involvement. 

Among patients receiving lurbinectedin monotherapy, the hazard ratio for death was 1.6 for platinum-resistant versus platinum-sensitive disease. 

In the second-line setting, median OS was 5.8 months in patients with platinum-resistant disease and 10.1 months in patients with platinum-sensitive disease. 

Lurbinectedin was generally well tolerated, with no new safety signals identified.

Treatment-related adverse events occurred in 33% of patients receiving lurbinectedin. The most frequently reported events included anemia (8%) and neutropenia (7%). Serious treatment-related adverse events occurred in 11% of patients. Adverse events led to treatment discontinuation in 8% of patients and dose reductions in 5% of patients. 

Fatal treatment-related adverse events occurred in 4 patients (approximately 1%), including events involving multiple organ dysfunction syndrome and sepsis, hypoxia and capillary leak syndrome, head injury, and febrile neutropenia and pneumonia.

 “Our findings extend the evidence base for lurbinectedin to a broader and more clinically heterogeneous population,” concluded Dr Badin et al. 

Source:

Badin FB, Lammers PE, Liu G, et al. Real-world effectiveness and safety of lurbinectedin in previously treated small cell lung cancer: Results from Jazz EMERGE 402. Lung Cancer. Published online: October 13, 2026. doi: 10.1016/j.lungcan.2026.109644