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Association details:
Biomarker:MSI-H/dMMR
Cancer:Solid Tumor
Drug:Jemperli (dostarlimab-gxly) (PD1 inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: A1 - Approval
Source:
Published date:
08/17/2021
Excerpt:
JEMPERLI is a programmed death receptor-1 (PD-1)–blocking antibody indicated for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced...solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer

Excerpt:
...- Participant has a tumor which can be categorized as dMMR or MSI-H by local or central assessment...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Go to data
Title:

Study of TSR-042, an Anti-programmed Cell Death-1 Receptor (PD-1) Monoclonal Antibody, in Participants With Advanced Solid Tumors

Excerpt:
...Cohort A1 (dMMR/MSI-H endometrial cancer) and Cohort A2 (MMR-proficient/MSS endometrial cancer)...
Trial ID:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line

Excerpt:
...All histologic subtypes of endometrial adenocarcinoma could be included if MMRd/MSI-H 9....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Randomized phase III trial in MMR deficient endometrial cancer patients comparing chemotherapy alone versus Dostarlimab in first line advanced/metastatic setting: DOMENICA STUDY (GINECO-EN105b/ENGOT-en13 study) Ensayo aleatorizado de fase III en pacientes con cáncer de endometriodeficiente que compara la quimioterapia sola frente a Dostarlimab en primera línea de tratamiento avanzado/metastásico: ESTUDIO DOMENICA (estudio GINECO-EN105b/ENGOT-en13)

Excerpt:
...All histologic subtypes of endometrial adenocarcinoma could be included if MMRd/MSI-H,7. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Phase 2 Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer Estudio de fase II de dostarlimab en pacientes con cáncer de recto dMMR/MSI-H localmente avanzado no tratado previamente

Excerpt:
...Inclusion criteria (Prescreening Period)- A Prescreening Period will only be available at sites/countries where local dMMR/MSI-H testing is not available. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Radiation and TSR-042 (Dostarlimab) in People With Endometrial Cancer After They Receive Surgery

Excerpt:
...- MMR-D or MSI-H (submission of report[s] required for....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Watch-and-Wait Approach With Dostarlimab in Localized dMMR/MSI-H Gastric Cancer: GERCOR Phase II Study

Excerpt:
...Tumor status confirmed to be dMMR/MSI...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

DOstarlimab in Patients With Recurrent or dMMR/MSI-H Endometrial Cancer

Excerpt:
...Patient has evidence of tumor DNA damage repair dysfunction (dMMR/MSI-H) via locally available, validated methodology....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer

Excerpt:
...- Has a tumor demonstrating the presence of either dMMR status or MSI-H...
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Antitumor Activity and Safety of Dostarlimab Monotherapy in Patients With Mismatch Repair Deficient Solid Tumors: A Nonrandomized Controlled Trial

Published date:
11/01/2023
Excerpt:
In this nonrandomized controlled trial, dostarlimab was a well-tolerated treatment option with rapid, robust, and durable antitumor activity in patients with diverse dMMR solid tumors.
DOI:
10.1001/jamanetworkopen.2023.41165
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Efficacy and safety of dostarlimab in UK-specific patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) or DNA polymerase epsilon, catalytic subunit (POLƐ)-mutated solid tumours in the GARNET study

Published date:
06/27/2023
Excerpt:
Median PFS was 5.4 months (3-year rate, 39.7%) and median OS was 18 months (3-year rate, 47.3%) in patients overall....Dostarlimab demonstrated durable, clinically meaningful anti-tumour activity in UK-specific patients with dMMR/MSI-H or POLƐ-mutated solid tumours...
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

549P - Progression-free survival (PFS) and overall survival (OS) in patients (pts) with mismatch repair deficient (dMMR) solid tumors treated with dostarlimab in the GARNET study

Published date:
09/05/2022
Excerpt:
We report on PFS and OS in pts with dMMR solid tumors from 2 expansion cohorts of the GARNET trial….Dostarlimab demonstrated durable antitumor activity and favorable PFS and OS in dMMR solid tumors, including EC, gastrointestinal, and other tumor types.
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

SO-9 Analysis of the immune-related endpoints of the mismatch repair–deficient non-endometrial solid cancers cohort from the GARNET study

Published date:
07/04/2021
Excerpt:
The secondary efficacy analysis includes 110 patients with dMMR...Confirmed irORR was observed in 50 (45.5%) dMMR patients, which included 2 patients with POLε-m...Dostarlimab demonstrated durable antitumor activity by irRECIST per IA across multiple tumor types.
DOI:
10.1016/j.annonc.2021.05.033
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Safety and efficacy of anti–PD-1 antibody dostarlimab in patients (pts) with mismatch repair-deficient (dMMR) solid cancers: Results from GARNET study.

Published date:
02/08/2021
Excerpt:
Confirmed ORR in dMMR pts was 38.7% (95% CI: 29.4, 48.6), with a complete response rate of 7.5%. ORR was consistent across tumor type...The Kaplan–Meier estimated probability of maintaining response at 12 and 18 months was 91.0% and 80.9% respectively....Dostarlimab demonstrated durable antitumor activity in a cohort of dMMR solid tumor pts, the majority of whom had GI cancers.
DOI:
10.1200/JCO.2021.39.3_suppl.9
Trial ID: