Real-world (RW) effectiveness and safety of lurbinectedin (lurbi) for previously treated extensive-stage small cell lung cancer (ES-SCLC): Final primary and subgroup analysis results of Jazz EMERGE 402.

Abstract

8079 Background: Lurbi received accelerated approval in 2020 for ES-SCLC that progressed on or after platinum-based treatment (Tx) based on a phase 2 basket trial and full approval in 2025 combined with atezolizumab as 1st-line maintenance Tx for ES-SCLC based on the phase 3 IMforte trial. Methods: The phase 4, prospective, observational Jazz EMERGE 402 trial (NCT04894591) evaluated lurbi for previously treated ES-SCLC in RW practice in North America (final data cut: July 17, 2025). The primary endpoint was overall response rate (ORR). Key secondary endpoints were progression-free survival (PFS), overall survival (OS), and safety. Effectiveness was assessed in all patients (pts) and in prespecified subgroups. Results: At the final data cut, 267 pts had received ≥1 cycle of lurbi. At baseline (BL), median (min–max) age was 67 (29–89) years, 52 (19%) pts had an ECOG PS ≥2, 67 (25%) had brain metastases, 84 (31%) had liver metastases, 88 (33%) had a chemotherapy-free interval (CTFI) <90 days, and 196 (73%) had ES-SCLC as the initial diagnosis. Pts received lurbi as 2nd-line (169 [63%]), 3rd-line (78 [29%]), or later (20 [7%]) Tx. Median (Q1–Q3) number of lurbi Tx cycles and Tx duration were 4 (2–7) and 91 (56–170) days. Granulocyte colony-stimulating factor was used in 99 (37%) pts (71 [27%] as primary prophylaxis). Six (2%) pts were receiving Tx at study completion; 261 (98%) discontinued Tx, with disease progression (183 [70%]) the primary reason. While lurbi was effective among all pts and poor-prognosis subgroups, better outcomes tended to occur in pts with CTFI ≥90 days and ECOG PS <2 (Table). Eighty-eight (33%) pts had Tx-related adverse events (TRAE); anemia (21 [8%]) and neutropenia (19 [7%]) were most common. Rates of serious neutropenic infection (5 [2%]), anemia (4 [1%]), and neutropenia (3 [1%]) were low. Conclusions: Lurbi was associated with clinically meaningful effectiveness and predictable/manageable safety in previously treated ES-SCLC in a RW population that included poor-prognosis subgroups. Clinical trial information: NCT04894591 . Effectiveness among all pts and by subgroup. AllN = 267 Age <65 Yearsn = 101 Age ≥65 Yearsn = 166 CTFI <90 Daysn = 88 a CTFI ≥90 Daysn = 137 a Initial LSn = 69 b Initial ESn = 196 b ECOG PS <2n = 178 c ECOG PS ≥2 n = 52 c ORR, d % (95% CI e ) 29 (23, 36) 30 (20, 43) 28 (20, 37) 24 (14, 37) 28 (19, 38) 33 (21, 47) 27 (20, 36) 26 (19, 35) 41 (24, 59) PFS, d months, median (95% CI) 3.3 (2.6, 4.1) 4.1 (2.8, 4.5) 2.9 (2.2, 3.8) 2.9 (2.0, 4.1) 3.3 (2.4, 4.2) 4.0 (2.4, 5.8) 3.3 (2.5, 4.1) 3.3 (2.6, 4.2) 2.6 (1.7, 5.2) OS, months, median (95% CI) 7.6 (6.4, 8.7) 8.2 (7.0, 10.6) 6.6 (5.8, 8.7) 5.8(4.6, 6.6) 9.3(7.1, 10.9) 8.7 (6.2, 10.6) 6.8 (6.0, 8.7) 8.1(6.6, 9.6) 5.2 (2.4, 7.9) a CTFI missing for 42 pts. b Stage missing for 2 pts. c ECOG PS missing for 37 pts. d Per RECIST v1.1 in pts with BL measurable disease. e Estimated using Clopper-Pearson exact method. LS, limited stage.