Small cell lung cancer: innovative therapy for the over 65s

The results indicate that in the elderly population, lurbinectedin appears to be superior to standard therapy in terms of efficacy.

The PharmaMara Spanish pharmaceutical company, presented at the Asco (American Society of Medical Oncology) Oncology Congress in Chicago an overview of studies on lurbinectedin therapy for the small cell lung cancer (SCLC), with particular attention to the international Lagoon trial and a survey conducted on patients over 65 years of age. Lurbinectedin is an oncogenic transcription inhibitor active in transcription-dependent tumors.

A phase II study of patients with small cell lung cancer treated with lurbinectedin as second-line therapy showed an overall response rate of 35.2% and a median duration of response of 5.3 months, with responses lasting for more than 6 months in 43.0% of cases. Based on these findings, lurbinectedin has already received accelerated approval from the FDA in the United States and other countries, including Switzerland. For definitive approval, the results of the phase III Lagoon study are awaited, which involves 705 patients from about 20 Italian centers and evaluates two experimental treatment arms (lurbinectedin alone or in combination with irinotecan) compared to a control arm (topotecan or irinotecan) in patients with relapses. The research centers involved include the Institut Gustave Roussy in France, the University Hospital 12 De Octubre in Madrid, the Chuv University Hospital in Lausanne, the University of Manchester and the Dana-Farber Cancer Institute in Boston.

Inclusion criteria in the study were age 18 years or older, a confirmed diagnosis of SCLC, a prior line of platinum-containing chemotherapy with or without anti-PD-(L)1, and at least one month off treatment. Patients with central nervous system metastases may participate if they have received prior treatment and are radiologically stable for at least 4 weeks. A specific independent committee monitors the progress of the study. The final results, if positive, will lead to final approval in the United States and can be presented to theEuropean Medicines Agency (EMA) for approval on the European continent.

The study conducted on patients over 65 is based on the observation that relapsed small cell lung cancer is a difficult disease to treat and that a considerable number of patients belong to this age group, with associated frailty and multiple comorbidities. The analysis specifically compares the study that led to the accelerated approval of lurbinectedin as second-line therapy for metastatic Sclc according to an every 3-week dosing regimen, with the Atlantis study that evaluated the combination of lurbinectedin/doxorubicin as treatment second-line for SCLC versus a topotecan/Cav control arm.

The results indicate that in the elderly population, the lurbinectedina appears to be superior to standard therapy in terms of efficacy (higher response rate, duration of response, and overall survival) and safety (lower incidence of haematological adverse events). These data reinforce the role of lurbinectedin as a therapeutic option for patients over 65 with relapsed SCLC.