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Published on: July 25, 2020
An ambispective, real-world multi-center study of DOstarlimab in patients with Recurrent or Advanced DNA mismatch
Alejandro Gallego1, Ainhoa Madariaga2, Purificación Estévez-García3
1Cancer Center Clínica Universidad de Navarra (CCUN), Department of Medical Oncology, Madrid, Spain; Cancer Center Clínica Universidad de Navarra (CCUN), Department of Medical Oncology, Pamplona, Spain.
Objective:
Patients with advanced or recurrent endometrial cancer who experience progression following platinum-based chemotherapy have limited treatment options. The phase I GARNET trial showed the high efficacy of dostarlimab in treating mismatch repair deficient (dMMR) and/or microsatellite instability-high (MSI-H) endometrial cancer.
Methods:
DORA is a multi-center, ambispective, observational real-world study evaluating the efficacy and safety of dostarlimab. The study included patients with dMMR/MSI-H endometrial cancer who had experienced tumor progression on or after a platinum-based treatment and had received at least 1 cycle of dostarlimab within the Spanish Expanded Access Program. The primary endpoints were objective response rate and duration of response.
Results:
A total of 129 patients from 57 of the Spanish Research Group for Gynaecological Cancer (GEICO) affiliated hospitals were enrolled, with 125 evaluable for radiological response. The median duration of dostarlimab administration was 8.8 months (interquartile range; 13.2), and 73 patients (57%) remained on therapy at the data cutoff. With a median follow-up of 11.6 months (range; 0.8-30.1), the objective response rate was 53.6% (95% CI 44.4 to 62.5). Complete response was observed in 27 patients (21.6%), and partial response in 40 (32%), with a median time to response of 2.9 months (95% CI 2.6 to 3.6). The median duration of response was not reached. The probability of maintaining the response at 12 and 24 months was 84.98% (95% CI 70.8 to 92.5) and 73.39% (95% CI 50.5 to 86.9), respectively. Treatment was discontinued due to toxicity in 4.7% of patients.
Conclusions:
Dostarlimab monotherapy in dMMR/MSI-H endometrial cancer patients shows similar efficacy in real-world practice to that observed in the GARNET trial.
Insights
Dostarlimab monotherapy demonstrates significant efficacy in treating advanced mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) endometrial cancer. Real-world data confirms its effectiveness in patients progressing after platinum-based chemotherapy.
Area of Science:
- Oncology
- Gynecologic Oncology
- Immunotherapy
Background:
- Advanced or recurrent endometrial cancer after platinum-based chemotherapy offers limited treatment options.
- Mismatch repair deficient (dMMR) and microsatellite instability-high (MSI-H) biomarkers identify patients who may benefit from specific therapies.
- The phase I GARNET trial established dostarlimab's efficacy in this patient population.
Purpose of the Study:
- To evaluate the real-world efficacy and safety of dostarlimab monotherapy.
- To assess treatment outcomes in patients with dMMR/MSI-H endometrial cancer who progressed on platinum-based chemotherapy.
- To compare real-world findings with the results from the GARNET clinical trial.
Main Methods:
- A multi-center, ambispective, observational real-world study (DORA) was conducted.
- Included patients with dMMR/MSI-H endometrial cancer progressing on or after platinum-based treatment.
- Patients received at least one cycle of dostarlimab via the Spanish Expanded Access Program; primary endpoints were objective response rate and duration of response.
Main Results:
- 129 patients were enrolled; 125 were evaluable for response.
- Objective response rate was 53.6% (95% CI 44.4 to 62.5), with 21.6% complete responses.
- Median duration of response was not reached, with 12-month response probability of 84.98%.
Conclusions:
- Dostarlimab monotherapy shows comparable efficacy in real-world settings to clinical trial data for dMMR/MSI-H endometrial cancer.
- The study supports dostarlimab as an effective treatment option for patients with advanced or recurrent endometrial cancer post-chemotherapy.
- Low discontinuation rates due to toxicity (4.7%) indicate a favorable safety profile in clinical practice.
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