Prospective phase 4 trial of effectiveness and safety of lurbinectedin in previously treated small cell lung cancer

The prospective, observational phase 4 Jazz EMERGE 402 trial evaluated lurbinectedin for previously treated small cell lung cancer (SCLC) in a diverse, real-world population. The primary endpoint was overall response rate (ORR). At data cutoff, 267 patients received at least one lurbinectedin dose. At baseline, median age was 67 years, 52 patients (19%) had an ECOG performance status ≥ 2, 67 (25%) had brain metastases, and 88 (33%) had platinum-resistant disease. ORR was 29% (95% CI 23-36) overall and 33% (25-42) in second-line treatment. Patients with brain metastases had lower ORR (17%, versus 32% without brain metastases; OR 0.28; 95% CI 0.10-0.76). Median progression-free survival (PFS) was 3.3 months (95% CI 2.6-4.1) and median overall survival (OS) was 7.6 months (6.4-8.7). Median OS was shorter with platinum-resistant disease versus platinum-sensitive disease (5.8 versus 9.3 months; HR 1.63; 95% CI 1.17-2.28). Eighty-eight patients (33%) had treatment-related adverse events; 21 discontinued due to adverse events. The authors conclude that lurbinectedin was associated with clinically meaningful effectiveness and predictable and manageable safety.