Summary
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.
Methods
The lurbinectedin trial arm (LTA) results were compared to outcomes from two real-world comparator arms (RWCA1 and RWCA2) sourced from ConcertAI electronic medical records (2010-2019). RWCA1 included patients with ECOG≤2 and those missing ECOG scores. RWCA2, a subset of RWCA1, included only patients with a known ECOG≤2. Propensity score weighting was used to balance measured confounders. ORR was assessed in two ways in the RWCAs due to the missingness of tumor response. ORR1 was assessed as the percentage of patients with a complete or partial response among all patients, and ORR2 was assessed among those with a recorded response or death within 90 days of treatment initiation. Cox regression was used to compare OS.
Results
This study included 105 patients in LTA, 121 in RWCA1, and 74 in RWCA2. ORR was approximately two-fold higher in the LTA compared to both RWCAs and across both definitions of ORR. The LTA had a higher proportion of patients with response to treatment with the differences in response rate ranging from 14.5% to 22.3%. Median survival time (months) was 9.3, 5.5, and 4.6 in the LTA, RWCA1, and RWCA2 respectively. Probability of survival was greater in LTA compared to RWCA1 and RWCA2 at 3 and 6 months.
Conclusions
Lurbinectedin demonstrated improved median OS and a higher response rate compared to other treatments in patients with relapsed/refractory SCLC.
