Novel regimen for HR-positive endometrial cancer on the way?

The combination of fulvestrant and abemaciclib displayed encouraging anti-tumour activity in a phase 2 study among patients with advanced or recurrent HR-positive endometrial cancer, supporting further investigation of this regimen in a phase 3 trial.

Dr Angela Green (Memorial Sloan Kettering Cancer Center, NY, USA) assessed the combination of the CDK4/6 dual inhibitor abemaciclib and the selective oestrogen receptor degrader fulvestrant in patients with advanced or recurrent HR-positive endometrial cancer (n=27). If 5 or more patients responded to therapy, the treatment regimen was considered ‘promising’.

“The overall response rate (ORR) was 44% and the median duration of response was 15.6 months,” said Dr Green. All of the responses were partial responses. In addition, 20% of the participants had stable disease. The authors also reported a median progression-free survival of 9.0 months.

The most frequently observed grade ≥3 treatment-related adverse events were neutropenia (22%) and anaemia (19%). Grade 1 or 2 diarrhoea was also common in the study population (89%). “We saw one case of grade 4 AST elevation, which was recovered with dose hold and dose reduction,” added Dr Green. Finally, Dr Green noted that participants with copy number-low/no specific molecular profile (CN-L/NSMP) tumours appeared to be more likely to respond to the regimen than participants with other molecular subtypes of endometrial cancer (ORR 59% vs 13%; P=0.042).

In conclusion, the promising activity and favourable safety profile of the combination of fulvestrant and abemaciclib in a population of patients with HR-positive endometrial cancer warrants further investigation in a phase 3 study.

1. Green AK, et al. A phase II study of fulvestrant plus abemaciclib in hormone-receptor positive advanced or recurrent endometrial cancer. Abstract 5511, ASCO Annual Meeting 2024, 31 May–4 June, Chicago, IL, USA.

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Posted on 18 July 202418 July 2024