In a recent publication in Lung Cancer, data from a post hoc analysis exploring the use of lurbinectedin for the treatment of SCLC demonstrated that the agent was more effective and less toxic than topotecan.
Regarding the objective of this study, the authors wrote, “This report focuses on lurbinectedin activity and safety in a subgroup of small cell lung cancer (SCLC) patients from the BASKET phase II study with chemotherapy-free interval (CTFI) ≥30 days. This pre-planned analysis was requested to obtain regulatory approval of lurbinectedin in Switzerland.”
The study included patients with extensive-stage SCLC, no central nervous system (CNS) metastases, and disease progression after platinum-containing therapy. Data for topotecan were obtained from the contemporary, randomized, controlled phase III study (ATLANTIS), which was employed as indirect external control in a matched patient population comprised of 98 patients.
The BASKET study was conducted between October 2015 and November 2020, and the ATLANTIS study was conducted between August 2016 and February 2020.
The results revealed that lurbinectedin demonstrated a statistically significant overall response rate (ORR) by investigator assessment (IA) of 41% compared with 25.5% in the topotecan control group referenced from the phase III ATLANTIS study (NCT02566993; P = .0382). The ORR by independent review was 33.7% for lurbinectedin versus 25.5% with topotecan. Moreover, lurbinectedin also demonstrated a greater average response duration than topotecan (independent review, 5.1 vs. 4.3 months; IA, 5.3 vs. 3.9 months). The average overall survival was 10.2 months versus 7.6 months in the lurbinectedin and topotecan groups, respectively.
With regard to safety, grade ≥3 hematological or lower abnormalities were remarkably lower with lurbinectedin versus topotecan and were principally anemia (12.0% vs. 54.1%), leukopenia (30.1% vs. 68.4%), neutropenia (47.0% vs. 75.5%), and thrombocytopenia (6.0% vs. 52.0%). Even though the usage of growth colony–stimulating factors was required with the administration of topotecan, the use of topotecan was linked with a higher rate of febrile neutropenia compared with lurbinectedin (6.1% vs. 2.4%).
Grade 3 or lower adverse events (AEs) were also reported considerably less in patients treated with lurbinectedin versus topotecan (55.4% vs. 90.8%). For treatment-related AEs, the reported incidence with lurbinectedin was 41.0% versus 82.7% with topotecan. The most common AEs were fatigue and gastrointestinal events, and alopecia was only detected with topotecan.
Based on their findings, the authors wrote, “A favorable safety profile was observed in this post hoc analysis for lurbinectedin compared to topotecan, especially for hematological toxicities.”
The authors added, “Based on the efficacy and safety outcomes shown in this post hoc analysis, patients with CTFI ≥30 days and no CNS metastases have a positive benefit/risk ratio with lurbinectedin, superior to that reported with topotecan. Lurbinectedin is more active, as measured by all usual outcome metrics, and is clearly less toxic and better tolerated than topotecan.”
Lastly, the authors noted that an ongoing confirmatory phase III trial (LAGOON; NCT05153239) is assessing lurbinectedin as a single agent or in combination with irinotecan versus topotecan or irinotecan in the population of adult SCLC patients who have failed one prior platinum-containing line with CTFI ≥30 days and controlled asymptomatic CNS metastases. The estimated study completion date is June 2025.
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