P63.01 Lurbinectedin in Pre-Treated Patients With Small Cell Lung Cancer and Malignant Pleural Mesothelioma in a Real World Setting

Abstract

Lurbinectedin, a selective inhibitor of oncogenic transcription is currently being investigated in patients with small cell lung cancer (SCLC) or malignant pleural mesothelioma (MPM) after failure of at least first-line therapy, with phase 2 studies showing promising results. In 2020, the FDA granted accelerated approval to lurbinectedin (Zepzelca®) for patients with metastatic SCLC with disease progression during or after platinum-based chemotherapy. Here, we present the first real-world data of lurbinectedin from two large heavily pre-treated patient cohorts, SCLC and MPM, treated in our tertiary referral university medical center. Lurbinectedin, a selective inhibitor of oncogenic transcription is currently being investigated in patients with small cell lung cancer (SCLC) or malignant pleural mesothelioma (MPM) after failure of at least first-line therapy, with phase 2 studies showing promising results. In 2020, the FDA granted accelerated approval to lurbinectedin (Zepzelca®) for patients with metastatic SCLC with disease progression during or after platinum-based chemotherapy. Here, we present the first real-world data of lurbinectedin from two large heavily pre-treated patient cohorts, SCLC and MPM, treated in our tertiary referral university medical center. Between November 2019 and December 2020, a total of 95 patients (43 SCLC and 52 MM) started treatment with lurbinectedin. All patients with SCLC and 81% of MM received lurbinectedin as third or further line of therapy. The median number of cycles that was administered was 2 (range: 1-12) for SCLC and 3 (range: 1-13) for MM. After 12 weeks, in the SCLC cohort, the disease control rate (DCR) was 29% and the objective radiological response (ORR) was 17%. The median progression free survival (mPFS) was 1.5 months (95% CI: 1.4–3.0), and median overall survival (mOS) was 7.0 months (95% CI: 4.7-not reached). In the MPM cohort, the DCR after 12 weeks was 32% and no tumor responses were registered. The mPFS was 2.8 months (95% CI: 1.4–4.2), while mOS was 7.2 months (95% CI: 5.9–not reached). In general, lurbinectedin was well tolerated. Dose reductions were applied in 27% of patients, mainly because of fatigue or hematologic toxicity. Lurbinectedin appears to be a clinically meaningful therapeutic option in heavily pre-treated patients with SCLC and mesothelioma.Table 1comparison of our real-world data to the phase II clinical trialsTrigo et al. (SCLC) (n=105)Erasmus MC (SCLC) (n=43)Metaxas et al. (MPM) (n=42)Erasmus MC (MPM) (n=52)Patients number105434252Treatment line2-33-42-32-3Median follow-up17.1 months7.2 monthsNA7.3 mMedian chemotherapy-free interval3.5 months1.9 monthsNA1.6 monthsDCR 12 weeks68%29%52%32%ORR 12 weeks35%17%4%0%Median PFS3.5 months1.5 months4.1 months2.8 monthsMedian OS9.3 months7.0 months11.1 months7.2 months Open table in a new tab