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Lurbinectedin shows activity in pretreated Ewing sarcoma
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WAILEA, Hawaii — Single-agent lurbinectedin induced partial responses among patients with advanced Ewing sarcoma, according to results of multicenter phase 2 basket study presented at the Connective Tissue Oncology Society Annual Meeting.
New therapeutic agents with different mechanisms of action are needed for Ewing sarcoma, because patients with advanced or relapsed disease have poor outcomes.
“Lurbinectedin (PM1183, PharmaMar) is a novel anticancer drug that inhibits active transcription of protein-coding genes and modulates the tumor microenvironment,” Vivek Subbiah, MD, assistant professor in the department of investigational cancer therapeutics at The University of Texas MD Anderson Cancer Center, said during his presentation.
Subbiah and colleagues evaluated the safety and efficacy of lurbinectedin in a basket trial of patients with several types of advanced solid tumors.
The current analysis included 25 adults (median age, 30 years; range, 18-74; men, n = 14) from a cohort of patients with Ewing sarcoma who received two or fewer prior chemotherapy-containing regimens. Twenty-three patients had an ECOG performance status of 0 or 1. Thirteen patients had extraosseous tumors, and six patients had three or more disease sites.
Patients received 3.2 mg/m2 lurbinectedin in a 1-hour infusion every 3 weeks. Twenty-three patients received a median of two cycles (range, 1-9), with a median total dose of 6.6 mg/m2 (range, 3.2-28.2).
Seventeen patients had data evaluable for efficacy, three of whom had a partial response. Eight patients achieved stable disease, which lasted for 3 months or longer for four patients. Median duration of response was 2.9 months (range, +1.5-5.5).
Median PFS was 4.1 months (95% CI, 1.4-5.1).
Most adverse events were related to myelosuppression, which included grade 3 and grade 4 neutropenia (50%), febrile neutropenia (13%) and thrombocytopenia (13%). Five patients experienced dose delay due to grade 2 to grade 4 neutropenia or grade 2 thrombocytopenia.
Four patients had dose reduction due to grade 4 neutropenia. Ten patients received granulocyte-colony stimulating factor to manage toxicities.
No patient withdrew due to or died of toxicity.
“Lurbinectedin as a single agent shows encouraging activity in advanced Ewing sarcoma, for which there is an unmet medical need,” Subbiah said. “Treatment in combination with other agents is warranted in this patient population.” – by Alexandra Todak
Reference:
Subbiah V, et al. Abstract 048. Presented at: CTOS Annual Meeting; Nov. 8-11, 2017; Maui, Hawaii.
Disclosures: PharmaMar funded this study. Subbiah reports research funding from AbbVie, Amgen, Bayer, Berghealth, Bluprint, Fujifilm, Genentech, GlaxoSmithKline, Incyte, LOXO, Novartis, NW Biotherapeutics, PharmaMar and Vegenics.