Lurbinectedin received accelerated approval for metastatic small cell lung cancer (SCLC) patients with disease progression on or after platinum chemotherapy based on the results of a single-arm phase 2 study. This study compares overall response rate (ORR) and overall survival (OS) in the lurbinectedin trial to other treatments from a real-world external control arm. The data in this abstract was accepted as an e-abstract at ASCO 2022. All rights reserved.

Lurbinectedin was approved in the US in June 2020 for the treatment of adult patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy. This study describes RW progression-free survival (rwPFS), time to discontinuation (rwTTD), and time to next treatment or death (rwTTNT/D) in patients treated with lurbinectedin in a RW setting. This study used a cohort of 2L SCLC patients treated with single-agent lurbinectedin in the nationwide Flatiron Health US electronic health record-derived de-identified database from 15/06/20 to 31/03/22. rwPFS, rwTTD, and rwTTNT/D were assessed from start of 2L (index date) until event or censor using Kaplan-Meier methods. Results were evaluated among all patients and the subsets with chemotherapy-free interval (CTFI) ≥ 90 days and ≥ 180 days. CTFI was measured as the time from last platinum therapy dose to progression or start of 2L (in the absence of progression). Of the 396 patients included, 222 (56.1%) had a CTFI ≥ 90 days and 49 (12.4%) had a CTFI ≥ 180 days. Median age was 67 years and 84.6% of patients had extensive stage disease at initial diagnosis. 24.5% had an ECOG score of 0, 43.2% had a score of 1, 17.2% had a score of 2, and 14.1% of patients did not have a documented ECOG status in the 30 days prior to index date. Platinum therapy + etoposide with or without immunotherapy was the 1L treatment in >99% of patients. Median rwPFS was longer in the subsets of patients with CTFI ≥ 90 days and ≥ 180 days (overall: 2.5 months, ≥ 90 days: 3.1 months, ≥ 180 days: 4.6 months). Similar trends were seen for rwTTD and rwTTNT/D. Patients treated with lurbinectedin as 2L monotherapy in this RW setting had outcomes consistent with those seen in the phase 2 clinical trial. Lurbinectedin provides an additional treatment option for relapsed SCLC patients, including those with platinum-sensitive disease.Table: 1539POverallCTFI ≥ 90 daysCTFI ≥ 180 daysN (%a)396222 (56.1%)49 (12.4%)Median age at index67.066.067.0ECOG status at indexb097 (24.5%)56 (25.2%)16 (32.7%)1171 (43.2%)93 (41.9%)18 (36.7%)268 (17.2%)39 (17.6%)5 (10.2%)34 (1.0%)1 (0.5%)0 (0.0%)Missing56 (14.1%)33 (14.9%)10 (20.4%)1L Platinumc + etoposide alone59 (14.9%)36 (16.2%)9 (18.4%)1L Platinumc + etoposide + immunotherapy334 (84.3%)184 (82.9%)40 (81.6%)Median time to event (95% CI) (months)rwPFS2.5 (2.2, 2.8)3.1 (2.7, 3.9)4.6 (4.0, 6.2)rwTTD2.5 (2.1, 3.5)3.7 (3.5, 4.1)4.8 (3.6, 5.6)rwTTNT/D3.6 (3.2, 4.1)4.7 (4.1, 5.2)5.8 (4.4, 8.2)a% of overall bAssessed within 30 days prior to index cPlatinum-based chemotherapy. Open table in a new tab

Lurbinectedin received accelerated FDA approval in June 2020 for treatment of adult patients with metastatic small-cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Approval was based on a single-arm, phase 2 trial, which demonstrated an overall response rate of 35.2%, a duration of response of 5.3 months, and a manageable safety profile. This study explored patient characteristics and treatment patterns of patients treated with lurbinectedin during the 16 months after approval in the United States (US).