The study met its primary endpoint, with just over half of the participants remaining progression-free at 12 weeks, without any new safety signals being observed, they add.
The researchers therefore note: “Lurbinectedin emerges as a new treatment option and evaluation in a larger, randomized trial is warranted.”
Indeed, 54% of the 42 patients given lurbinectedin were progression-free at 12 weeks, and the median progression-free survival (PFS) was 4.1 months. In all, 58.4%, 30.5%, and 12.7% of patients remained free from progression at 3, 6, and 9 months, respectively.
The median overall survival (OS) was 11.1 months, with a respective 73.8% and 44.9% of patients alive at 6 and 12 months. The researchers note that the median OS “came close to the upper limits of any published OS so far.”
One patient each had a complete and partial response to treatment, while 47.6% had stable disease for at least 12 weeks, giving a disease control rate of 52.4%. The median duration of disease control was 6.6 months, with 27.3% of patients displaying disease control for at least 8 months. ...