Real-world effectiveness and safety of lurbinectedin in previously treated small cell lung cancer: results from Jazz EMERGE 402

Background In extensive-stage small cell lung cancer (ES-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. Methods Jazz EMERGE 402 was a prospective, observational, phase 4 trial (NCT04894591) that evaluated lurbinectedin for previously treated SCLC in a diverse, real-world population. The primary endpoint was overall response rate (ORR). Key secondary endpoints were progression-free survival (PFS), overall survival (OS), and safety. Results As of July 17, 2025, 267 patients received ≥1 lurbinectedin dose. At baseline, median age was 67 years, 52 (19%) patients had an Eastern Cooperative Oncology Group score ≥2, 67 (25%) had brain metastases, and 88 (33%) had platinum-resistant disease. ORR (95% confidence interval [CI]) was 29% (23%–36%) overall (n = 189) and 33% (25%–42%) in second-line treatment (n = 118). Patients with brain metastases had lower ORR (17% vs 32% without; odds ratio, 0.28 [95% CI: 0.10–0.76]). Median (95% CI) PFS and OS were 3.3 (2.6–4.1) and 7.6 (6.4–8.7) months. OS was shorter with platinum-resistant vs platinum-sensitive disease (5.8 vs 9.3 months; hazard ratio, 1.63 [95% CI: 1.17–2.28]). Eighty-eight (33%) patients had treatment-related adverse events, including anemia (8%) and neutropenia (7%); 21 (8%) discontinued treatment due to adverse events. Conclusions In a broad, real-world population with previously treated SCLC, lurbinectedin was associated with clinically meaningful effectiveness and predictable and manageable safety. Lower ORR and OS were seen in patients with brain metastases and platinum-resistant disease, respectively.