Real-world safety and healthcare resource utilization (HCRU) of lurbinectedin (lurbi) in patients (pts) with small cell lung cancer (SCLC): Jazz EMERGE 402 updated analysis.

person Firas Benyamine Badin Baptist Health Medical Group, Lexington, KY info_outline Firas Benyamine Badin, Philip Edward Lammers, Mehul P. Patel, Leonid Shunyakov, Dennis Slater, Catherine Labbé, Navit Naveh, Raj Hanvesakul, Wenyan Li, Badri Rengarajan, Balazs Halmos, Anne Boccuti

Authors person Firas Benyamine Badin Baptist Health Medical Group, Lexington, KY info_outline Firas Benyamine Badin, Philip Edward Lammers, Mehul P. Patel, Leonid Shunyakov, Dennis Slater, Catherine Labbé, Navit Naveh, Raj Hanvesakul, Wenyan Li, Badri Rengarajan, Balazs Halmos, Anne Boccuti Organizations Baptist Health Medical Group, Lexington, KY, Baptist Cancer Center, Memphis, TN, Rochester Regional Health, Rochester, NY, Carrie J. Babb Cancer Center, Bolivar, MO, Eastern Connecticut Hematology and Oncology Associates, Norwich, CT, Centre de Recherche de l’Institut Universitaire de Cardiologie et de Pneumologie de Québec – Université Laval, Québec, QC, Canada, Jazz Pharmaceuticals, Philadelphia, PA, Jazz Pharmaceuticals, Oxford, United Kingdom, Jazz Pharmaceuticals, Palo Alto, CA, Montefiore Einstein Comprehensive Cancer Center, Bronx, NY Abstract Disclosures Research Funding Jazz Pharmaceuticals Background: Lurbi monotherapy received approval in multiple countries, including accelerated US FDA approval and conditional Health Canada approval for adults with metastatic (US) or stage III/metastatic (Canada) SCLC with disease progression on or after platinum-based chemotherapy, based on a phase 2, open-label, single-arm trial (Trigo et al, Lancet Oncol 2020). Jazz EMERGE 402 (NCT04894591) is a phase 4 observational study assessing the effectiveness, safety profile, and HCRU of lurbi in pts with extensive-stage SCLC treated in real-world clinical settings. Here, we report updated safety data and HCRU. Methods: This study is enrolling pts with extensive-stage SCLC treated with lurbi according to the local approved label in the US and Canada. Results: Enrollment is ongoing with a target of 300 pts. Between 28JUN2021 and 27DEC2022, 105 pts were enrolled and followed for ≥6 months after the first dose of lurbi (data cutoff: 27JUN2023). The median (range) age was 67 (44-87) years; 72 (69%) pts had prior immunotherapy; 22 (21%) had an Eastern Cooperative Oncology Group performance status of ≥2; and 25 (24%) had central nervous system involvement. All pts received ≥1 cycle of lurbi; 56 (53%) as second-line (2L) and 37 (35%) as third-line (3L) therapy. The median (range) number of lurbi cycles was 4 (1-31) and the median (range) duration of exposure was 97 (21-694) days. Dose modifications occurred in 27 (26%) pts, with 17 (16%) requiring dose reductions. Granulocyte colony-stimulating factor was administered in 43 (41%) pts (34 [79%] as primary and 7 [16%] as secondary prophylaxis; 2 [5%] were unknown). At the time of data extraction, lurbi treatment was ongoing in 11 (10%) pts and 23 (22%) pts received subsequent anticancer therapy after lurbi. Treatment-related adverse events (TRAEs) were reported in 40 (38%) pts and treatment-related serious adverse events (SAEs) in 13 (12%) pts. The most common TRAEs were anemia (n = 13, 12%), neutropenia (n = 10, 10%), nausea (n = 8, 8%), and fatigue (n = 7, 7%). Thirty-six pts were hospitalized for a median (interquartile range [IQR]) duration of 10 (4, 18) days ( Table ). No pts were hospitalized on the first day of treatment; 4 pts were hospitalized during the first 21-day cycle. The most common reasons for hospitalization were pneumonia (n = 10, 28%) and sepsis (n = 6, 17%; one was an SAE). Conclusions: In this phase 4 study, lurbi was well tolerated, with low rates of HCRU and a safety profile generally consistent with that reported in the phase 2 trial. Clinical trial information: NCT04894591. HCRU in Jazz EMERGE 402. 2L (n = 56) 3L (n = 37) Total (N = 105) Pts hospitalized, n (%) 21 (38) 10 (27) 36 (34) Median duration of stay (IQR), days 12 (3, 20) 11 (8, 17) 10 (4, 18) Pts with emergency room visits, n (%) 13 (23) 10 (27) 25 (24) Blood transfusions, n (%) 5 (9) 5 (14) 12 (11) Pt follow-up location, a n (%) Home Hospice 28 (50) 13 (23) 21 (57) 10 (27) 54 (51) 26 (25) a At end of treatment.

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