GSK published positive data on dostarlimab in dMMR solid tumors

On January 16, GlaxoSmithKline (GSK) announced the latest data from the GARNET Study F Queue, which is used primarily to assess the role of dostarimab in non-endometrial advanced solid tumors with mismatch repair defects (dMMR), which was presented at the 2021 American Society of Clinical Oncology Gastrointestinal Oncology Symposium (ASCO GI).
results showed that the objective remission rate (ORR) of patients with DMMR advanced solid tumors treated with dostarlimab (PD-1 monoclonal antibody) was 38.7% (N s 106,95% CI; 29.4-48.6).
, after 12.4 months of medium follow-up, the medium remission duration (DoR) was not yet reached and all types of tumors had lasting remission. The
GARNET trial of Queue F was primarily recruited for patients with dMMR-type non-endometrial solid tumors, the majority of whom had the highest proportion of patients with gastrointestinal tumors, colorectal cancer, stomach cancer and small intestine cancer, and most of the patients with solid tumors (n s 81) who had received 2 or more systemic treatments.
group of patients were treated with dostarlimab every 3 weeks at 500 mg, 4 doses, followed by dostarimab at 1000 mg every 6 weeks for up to 2 years or for disease progression or active termination.
the main clinical endpoint of the study was the evaluation of ORR and DoR.
objective remission rates were consistent in patients with colorectal cancer (n s 69) and non-colorectal cancer (n s 37), including small intestine cancer, stomach cancer, pancreatic cancer, ovarian cancer, liver cancer and other types of solid cancer.
in colorectal cancer patients, the ORR was 36.2% (95% CI; 25.0 to 48.7), ORR for non-colorectal cancer patients was 43.2% (95% CI; 27.1-60.5), of which 8% were in complete remission.
Of patients who received one or more doses of dostarlimab for assessable safety, treatment-related adverse events (TRAEs) showed good resistance to dostarlimab in the overall group and low dostarlimab suspension (3.5%).
most commonly reported TRAEs were weakness (13%), diarrhea (13%), itching (13%), joint pain (9%) and fatigue (9%).
8% of patients have LEVEL 3 or higher TRAE.
the study did not report deaths related to the use of dostarlimab.
The U.S. Food and Drug Administration and the European Medicines Agency are currently reviewing dostarimab's bio-licensing and marketing licensing applications separately to treat people with relapsed or advanced DMMR/microsatellite instability (MSI-H) endometrial cancer who progress in platinum chemotherapy or later.
has not yet been approved for use anywhere in the world.
Dostarlimab is an humanized PD-1 monoclonal antibody that binds to the high affinity of the PD-1 subject and blocks its interaction with liants PD-L1 and PD-L2.
In addition to the GARNET trial, dostarlimab is conducting other registered clinical studies simultaneously, including phase III RUBY studies for patients with relapsed or primary advanced endometrial cancer (SOC) chemotherapy and the first phase III platinum therapy in combination with dostarlimab and niraparib to compare SOC platinum therapy as a first-line treatment for stage III or phase IV non-mucous epithelioid ovary cancer.
Dostarlimab is also being evaluated in patients with metastasis cancer using a combined treatment with other therapeutic drugs.
source: GSK presents positive efficacy data of dostarlimab in mismatch repair-deficient (dMMR) solid cancers at ASCO Gastrointestinal Cancer Symposiums