KEY TAKEAWAYS
- This phase 2 study examines abemaciclib and letrozole in patients suffering from advanced, recurrent, or metastatic ER+ ovarian cancer.
- The primary endpoint is ORR as per RECIST v1.1. Secondary endpoints include DOR, CBR, PFS, OS, and adverse events (AEs).
Low-grade serous ovarian cancer (LGSOC) and adult-type granulosa cell tumor (aGCT) are uncommon forms of ovarian cancer, making up about 8% and 5% of all cases, respectively. Traditional chemotherapy often yields unsatisfactory results for these types, leading researchers to explore alternative treatments.
One promising approach involves using the CDK4/6 inhibitor abemaciclib and an aromatase inhibitor like letrozole. This combination has improved patient outcomes in estrogen receptor-positive (ER+) breast cancer. The study aims to assess if this drug duo could similarly enhance responses in ER+ ovarian cancer.
This phase 2 clinical trial administered abemaciclib (150 mg twice daily) and letrozole (2.5 mg once daily) in patients suffering from advanced, recurrent or metastatic ER+ ovarian cancer who have not responded to at least one round of platinum-based chemotherapy.
Two groups are being evaluated: one with LGSOC patients and another with aGCT patients, with up to 50 patients with ER+ tumors in each group. Recruitment will occur across three sites in Belgium, 5 in France, 5 in Spain, and 3 in the Netherlands.
The primary aim is the overall response rate (ORR) based on RECIST v1.1 criteria. Secondary goals involve evaluating the duration of response (DOR), clinical benefit rate (CBR), progression-free survival (PFS), overall survival (OS), and any adverse events (AEs). Quality of life metrics will be collected using EQ-5D-5L and EORTC QLQ-C30 surveys.
In terms of exploratory objectives, the study will look at blood and tissue biomarkers like ER, PR, ctDNA, mutation load, and methylation patterns to see if they correlate with treatment success. An interim analysis will be conducted at the 24-week mark after 15 patients in each group have been assessed. If the response rate exceeds 1 in 15 patients, an additional 30 patients per group will be included
Source: https://www.emma.events/site/programme/?sessiondetail=4534566&trackid=0&a=esgo2023#!
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT05872204
Ottenbourgs, T., Nieuwenhuysen, E.V. A Phase II, Multicentre, Open-Label Study Of Abemaciclib And Letrozole In Patients With Estrogen Receptor-Positive Rare Ovarian Cancer.
