In a presentation at the recent American Society of Clinical Oncology Annual Meeting, researchers presented updated safety data and healthcare resource utilization (HCRU) for the use of lurbinectedin (lurbi) in patients with SCLC.

The authors wrote, “Lurbi monotherapy received approval in multiple countries, including accelerated U.S. FDA approval and conditional Health Canada approval for adults with metastatic (US) or stage III/metastatic (Canada) SCLC with disease progression on or after platinum-based chemotherapy, based on a phase 2, open-label, single-arm trial. Jazz EMERGE 402 is a phase 4 observational study assessing the effectiveness, safety profile, and HCRU of lurbi in patients with extensive-stage SCLC treated in real-world clinical settings. Here, we report updated safety data and HCRU.”

This study is enrolling patients with extensive-stage SCLC treated with lurbi according to the local approved label in the United States and Canada. In this phase IV trial, lurbi is administered by IV infusion over 60 minutes every 21 days.

The researchers noted that the study enrollment is ongoing, with a target of 300 patients. Between June 28, 2021, and December 27, 2022, 105 patients were enrolled and followed for ≥6 months after the first dose of lurbi, with a cutoff date of June 27, 2023.

The study cohort’s characteristics include an average age of 67 years (with a range of 44-87 years), 72 (69%) patients having prior immunotherapy, 22 (21%) having an Eastern Cooperative Oncology Group performance status of ≥2, and 25 (24%) having central nervous system involvement.

All patients in the study cohort received ≥1 cycle of lurbi, with 56 (53%) as second-line (2L) and 37 (35%) as third-line (3L) therapy. The median (range) number of lurbi cycles was noted as 4 (1-31), and the median (range) duration of exposure was 97 (21-694) days. Dose adjustments occurred in 27 (26%) patients, with 17 (16%) requiring a dose reduction.

Among the study cohort, granulocyte colony–stimulating factor was given to 43 (representing 41%) patients, with (34 patients [79%] as primary prophylaxis and seven patients [16%] as secondary prophylaxis; two patients [5%] were unknown). At the time of data extraction, lurbi treatment was ongoing in 11 (10%) patients, and 23 (22%) patients received subsequent anticancer therapy after lurbi.

The results also revealed that treatment-related adverse events (TRAEs) were reported in 40 (38%) patients and treatment-related serious adverse events (SAEs) in 13 (12%) patients, with the most common TRAEs documented as anemia (n = 13, 12%), neutropenia (n = 10, 10%), nausea (n = 8, 8%), and fatigue (n = 7, 7%). Additionally, 36 patients were hospitalized for a median (interquartile range [IQR]) duration of 10 (4, 18) days.

No patients were hospitalized on the first day of treatment; four patients were hospitalized during the first 21-day cycle. The most common reasons for hospitalization were pneumonia (n = 10, 28%) and sepsis (n = 6, 17%; one was an SAE).

Based on their findings, the authors wrote, “In this phase 4 study, lurbi was well tolerated, with low rates of HCRU and a safety profile generally consistent with that reported in the phase 2 trial.”

The JAZZ Emerge 402 trial is a phase IV, prospective, single-arm, multicenter, observational study to gather safety and outcome data of Zepzelca (lurbinectedin) in adult participants with extensive-stage SCLC who were previously exposed to at least one line of treatment with platinum-based chemotherapy. According to clinicaltrials.gov, the estimated study completion date is June 30, 2030.

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.

Click here to return to Lung Cancer Update.