medwireNews: Lurbinectedin has clinical activity and acceptable toxicity in the second- and third-line treatment of malignant pleural mesothelioma, say phase 2 trial investigators.
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.
The trial participants received lurbinectedin at a dose of 3.2 mg/m2 every 3 weeks – for a median of five cycles, over 98 days – until progression, unacceptable toxicity, or patient consent withdrawal. At initial diagnosis, 78.6% of patients had an epithelioid histology, 11.9% had a sarcomatoid histology, and the remaining 9.5% were biphasic. All patients had previously received platinum–pemetrexed, and 10 had received prior immunotherapy.
No significant differences in survival outcomes were observed based on histology or prior immunotherapy, and so the researchers comment in Annals of Oncology that “lurbinectedin is likely to equalise the prognosis of these [malignant pleural mesothelioma] subtypes,” where usually “[e]pithelioid mesotheliomas exhibit a better outcome than mixed/sarcomatoid.”
Yannis Metaxas (Kantonsspital Graubünden, Chur, Switzerland) and colleagues say that “lurbinectedin exhibited an acceptable safety profile.”
Half of all patients in this study experienced at least one treatment-related grade 3–4 adverse event (AE), most commonly neutropenia and fatigue, which accounted for 23.8% and 16.7% of such events, respectively. Just over a quarter (28.6%) of patients needed a dose reduction, and although no patients discontinued treatment due to grade 3–4 AEs, seven stopped due to prolonged grade 1–2 toxicity. There were no treatment-related deaths.
They also say that “[w]hile quality-of-life assessments would have provided further insights into lurbinectedin’s impact on [malignant pleural mesothelioma] patients’ daily lives, of note is that no patient discontinued treatment due to grade 3–4 toxicity issues.”
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