Findings from a study published in the Journal of Clinical Oncology revealed that second-line treatment with lurbinectedin and irinotecan demonstrated a favorable risk/benefit profile and generated high, durable response rates in high-risk patients with SCLC, particularly those with a chemotherapy treatment-free interval (CTFI) of more than 30 days.

The study included 101 eligible patients, and baseline characteristics included a median age of 63 years (range, 45-77 years), 60.4% males, 76.2% Eastern Cooperative Oncology Group (ECOG) performance status of 1, 28.7% central nervous system involvement, 39.6% bulky disease, and 41.6% pretreated with immunotherapy.

Key findings presented at the 2024 American Society of Clinical Oncologists Annual Meeting revealed that the combination of lurbinectedin and irinotecan achieved a 43.6% overall response rate in high-risk SCLC patients. The median duration of response was 7.1 months, with a median progression-free survival of 4.7 months. Moreover, median overall survival was 9.6 months, with a 12-month overall survival rate of 43.4%.

The safety profile was manageable, and treatment-related adverse events (AEs) were observed in 99.0% of patients (grade ≥3 in 69.3%). The most relevant grade ≥3 events/abnormalities were neutropenia (52.5%), anemia (27.7%), diarrhea (19.8%), fatigue (18.8%), and febrile neutropenia (9.9%). Treatment-related serious AEs occurred in 25.0% of patients, and 5.0% were discontinued due to treatment-related AEs. No treatment-related deaths occurred.

Based on the findings, the authors concluded, “The LUR/IRI [lurbinectedin/irinotecan] combination showed promising antitumor activity and a manageable safety profile in these patients with poor prognosis, particularly those with CTFI >30 days. These encouraging results reinforce the rationale for including this combination as an experimental arm in the ongoing pivotal phase III LAGOON trial (NCT05153239) in relapsed SCLC with CTFI>30 days.”

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