GARNET
Dostarlimab for recurrent or advanced mismatch repair-deficient endometrial cancer: dMMR endometrial cancer expansion cohort (cohort A1) of the GARNET study
Phase 1N = 104NCT02715284
- Population
- Recurrent or advanced dMMR endometrial cancer after platinum-based chemotherapy: 104 treated, of whom 71 with measurable disease at baseline and at least 6 months of follow-up were evaluable for response
- Design
- Ongoing open-label, single-group, multicohort phase 1 study; this prespecified analysis covers expansion cohort A1 (dMMR endometrial cancer by local immunohistochemistry, progression during or after platinum-based doublet chemotherapy, no more than 2 lines for advanced or recurrent disease). Dostarlimab 500 mg every 3 weeks for 4 doses, then 1000 mg every 6 weeks until progression, toxicity or withdrawal. Data cutoff 8 July 2019. ClinicalTrials.gov lists 729 participants across all cohorts.
- Primary endpoint
- ORR, DOR
- Arms
- Dostarlimab (single group) (experimental, n = 104): Dostarlimab 500 mg every 3 weeks for 4 doses, then 1000 mg every 6 weeks
- People
- Oaknin A, GARNET
Show the numbers
| Endpoint | Analysis | Dostarlimab (single group) | Control | Effect |
|---|---|---|---|---|
| ORR71 patients evaluable for efficacy (of 104 treated)Confirmed objective response rate by blinded independent central review according to RECIST 1.1 | interimmedian follow-up 11.2 monthsOaknin 2020 | 42.3% (30.6–54.6%) | — | 30 of 71 patients responded: 9 complete (12.7%) and 21 partial responses (29.6%). Single-arm cohort; not comparable with randomised arms. |
| DOR30 responders among the 71 evaluable patientsDuration of response by blinded independent central review according to RECIST 1.1; Kaplan-Meier estimate of maintaining response | interimmedian follow-up 11.2 monthsOaknin 2020 | 96.4% at 6 mo; 76.8% at 12 mo | — | Median duration of response had not been reached at a median follow-up of 11.2 months. |
| PFS71 patients evaluable for efficacy (of 104 treated) | interimmedian follow-up 11.2 monthsOaknin 2020 | median 8.1 months (3–18) | — | Secondary endpoint, blinded independent central review. |
| Endpoint | Analysis | Dostarlimab (single group) | Control | Effect |
|---|---|---|---|---|
| ORR71 patients evaluable for efficacy (of 104 treated)Confirmed objective response rate by blinded independent central review according to RECIST 1.1 | interimmedian follow-up 11.2 monthsOaknin 2020 | 42.3% (30.6–54.6%) | — | 30 of 71 patients responded: 9 complete (12.7%) and 21 partial responses (29.6%). Single-arm cohort; not comparable with randomised arms. |
| DOR30 responders among the 71 evaluable patientsDuration of response by blinded independent central review according to RECIST 1.1; Kaplan-Meier estimate of maintaining response | interimmedian follow-up 11.2 monthsOaknin 2020 | 96.4% at 6 mo; 76.8% at 12 mo | — | Median duration of response had not been reached at a median follow-up of 11.2 months. |
| PFS71 patients evaluable for efficacy (of 104 treated) | interimmedian follow-up 11.2 monthsOaknin 2020 | median 8.1 months (3–18) | — | Secondary endpoint, blinded independent central review. |
- Dostarlimab (single group) (experimental)
Data table (modelled values)
| Months | Dostarlimab (single group) |
|---|---|
| 0 | 100.0% |
| 3 | 99.1% |
| 6 | 96.4% |
| 10 | 84.0% |
| 13 | 76.8% |
- Dostarlimab (single group) (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Dostarlimab (single group) |
|---|---|
| 0 | 100.0% |
| 5 | 65.2% |
| 10 | 42.5% |
| 15 | 27.7% |
| 20 | 18.1% |
Appears in
Sources
Oaknin A, Tinker AV, Gilbert L, Samouëlian V, Mathews C, Brown J, et al. Clinical Activity and Safety of the Anti-Programmed Death 1 Monoclonal Antibody Dostarlimab for Patients With Recurrent or Advanced Mismatch Repair-Deficient Endometrial Cancer: A Nonrandomized Phase 1 Clinical Trial. JAMA Oncol. 2020;6(11):1766-1772.