2023-06-06 16:48:33
An overview of studies on small cell lung cancer (SCLC) in lurbinectedin therapy was the focus of the presentations of the Spanish pharmaceutical company PharmaMar at the Asco (American Society of Medical Oncology) Oncology Congress, which has just concluded in Chicago . Of particular interest is the international Lagoon trial and a survey on patients over 65. Lurbinectedin – reports a note – is an inhibitor of oncogenic transcription, active in transcription-dependent tumors. A phase II basketball study in patients with small cell lung cancer treated with the molecule in second line showed an overall response rate of 35.2% and a median duration of response of 5.3 months, with durable responses (43 .0% ≥ 6 months).
Based on these results – continues the company – lurbinectedin has already obtained accelerated approval by the US FDA and in other countries, including Switzerland. Final approval is awaited for the responses of the Lagoon trial, a phase III study involving 705 patients and about 20 Italian centres, with the evaluation of two experimental arms (lurbinectedin alone or with irinotecan) compared to the Investigator’s Choice (topotecan or irinotecan ) as a control arm in patients with relapses. The other research centers involved range from the Institut Gustave Roussy in France to the 12 De Octubre University Hospital in Madrid, from the Chuv University Hospital in Lausanne to the University of Manchester and the Dana-Farber Cancer Institute in Boston.
The main inclusion criteria are: age equal to or greater than 18 years; confirmed diagnosis of Sclc; a prior line of platinum-containing chemotherapy with/without anti-PD-(L)1 and with a treatment-free period equal to or greater than one month. Patients with central nervous system metastases can participate if pretreated and radiologically stable for at least 4 weeks. An independent Data Monitoring Committee oversees the conduct of the study. The final results, if positive – the note details – will lead to definitive approval in the US so that they can also be presented to the European drug regulatory agency EMA.
The study on the ‘over 65s’, on the other hand, assumes that relapsed small cell lung cancer is a difficult disease to treat and a considerable number of patients are elderly with associated frailty and numerous comorbidities. This analysis specifically compares the study that led to the accelerated FDA approval of lurbinectedin every 3 weeks as second-line therapy in metastatic SCLC and the Atlantis study, which evaluated the lurbinectedin/doxorubicin combination as second-line treatment. for Sclc versus a topotecan/Cav control arm.
The result is that in elderly patients – concludes the note – lurbinectedin appears to be superior to standard of care in terms of efficacy (higher response rate and longer duration of response and overall survival) and safety (fewer associated haematological adverse events), which strengthens its role as a therapeutic option in patients over 65 with Sclc recurrence.
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