KEYTRUDA, as a single agent, is indicated for the treatment of patients with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
Clinical Trial Results
Advanced MSI-H/dMMR Endometrial Carcinoma
KEYTRUDA, as a single agent, is indicated for the treatment of patients with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
Clinical Findings from KEYNOTE-158
KEYNOTE-158 data from cohorts D and K
Objective Response Rate (ORR)
Efficacy was evaluated in 90 patients who received at least 1 dose of KEYTRUDA.Response
Response
Duration of Response (DOR)
KEYTRUDA (n=41) |
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Median DORNot reached(range: 2.9–55.7+ months) |
Patients with responses lasting ≥12 months68% |
Patients with responses lasting ≥24 months44% |
Study Design for KEYNOTE-158
Study Overview
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Study Arm
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End Points
Major efficacy outcome measuresb:
- Objective response rate (ORR)
- Duration of response (DOR)
Assessment of tumor status was performed every 9 weeks for the first 12 months, and every 12 weeks thereafter.
Patient Characteristics
KEYNOTE-158 enrolled and evaluated the efficacy of 90 patients with unresectable or metastatic MSI-H or dMMR endometrial carcinoma who received at least 1 dose of KEYTRUDA.
Baseline Characteristics (n=90):
- Median age: 64 years (range: 42–86)
- Demographics:
- White: 83%
- Asian: 8%
- Black: 3%
- Hispanic or Latino: 12%
- ECOG PS:
- Score of 0: 39%
- Score of 1: 61%
- Disease state at study entry:
- M0: 4%
- M1: 96%
- Prior lines of therapy:
- 1: 51%
- ≥2: 48%
- 9 patients received only adjuvant therapy before study
- 1 patient received only neoadjuvant and adjuvant therapy before the study
Appropriate Patients
Hypothetical Patient Based on Those Studied in KEYNOTE-1581
