PD-(L)1 field GSK shines! Dostarlimab treatment for late-stage or recurrent endometrial cancer shows strong efficacy, with a total remission rate of 42%!

April 25, 2020 /
Bio-Valley
BIOON/ -- GlaxoSmithKline
(GSK) recently released the latest analysis of the anti-PD-1 therapy dotarlimab (formerly known as TSR-042) Phase I/II clinical study GARNET The results showed that dotarlimab treatment provided clinically significant results in patients with recurrent or advanced mismatch repair defects (dMMR) endometrial cancer during or after chemotherapy this latest analysis included patients with dMMR endometrial cancer, who had measurable diseases at baseline examination and followed up with the data deadline for 6 months (n-71) In the study, patients received 4 doses of dotarlimab 500mg every 3 weeks (Q3W) and then 1000 mg every 6 weeks (Q6W) until the disease progressed The main endpoint is the Independent Center for Blindness review synod (ORR) and mitigation duration (DOR) based on the criteria 1.1 of the evaluation criteria for the efficacy of solid tumors (RECIST v1.1) it's worth mentioning that The GARNET study is the most data to evaluate an anti-PD-1 treatment for endometrial cancer study data show that the ORR treated by dotarlimab in was 42% (95% CI: 31-55), and the disease control rate (DCR) was 58% (95% CI: 45-69) Overall, 13% of patients were in complete remission (PR) and 30% were partially resonated (PR) At the data cut-off, the median follow-up time was 11.2 months, and the median DOR had not yet reached (1.87 plus to 19.61 plus months) safety group included all patients with dMMR endometrial cancer who received at least one dose of dotarlimab treatment (n-104) The results showed that dotarlimab had good tolerance, low discontinuation rate (2%) for the treatment of related adverse events (TRAE), and was consistent with the safety of other anti-PD-1 therapies The most common TRAEs include fatigue (15%), diarrhea (15%), fatigue (14%) and nausea (13%) Dotarlimab-related deaths were not reported in the study women with advanced or recurrent endometrial cancer have limited treatment options and poor prognosis The results observed in the GARNET study suggest that dotarlimab has the potential to provide a new treatment option for the female patient population with this challenging disease GARNET is an ongoing phase I/IIB study that is evaluating dotarlimab as a single-drug therapy for patients with advanced solid tumors The IIB section of the study consisted of five extended cohorts: dMMR/microsatellite instability (MSI-H) endometrial cancer (queue A1), mismatch repair of normal endometrial cancer (queue A2), non-small cell lung cancer (queue E), dMMR/MSI-H non-endometrial cancer (queue F), platinum-resistant ovarian cancer (cogG) without BRCA mutation Currently, the GARNET study is still in the group of patients endometrial cancer (EC) is a major type of uterine cancer, which is formed in the endometrium EC can be divided into mismatch repair defects/microsatellite instability (dMMR/MSI-H) or mismatch repair normal/microsatellite stability (MSI-H) For EC patients whose condition progresses during or after first-line treatment, the treatment option is limited EC is the sixth most common female cancer in the world dotarlimab is a research-based humanized anti-PD-1 monoclonal antibody that binds to PD-1 receptors and blocks their interactions with ligands PD-L1 and PD-L2 in addition to the GARNET study, GlaxoSmithKline are evaluating dotarlimab combined standard care (chemotherapy) for the treatment of women with recurrent or advanced endometrial cancer in Phase III RUBY trials In addition, the company is evaluating dotarlimab in combination with other drugs to treat patients with advanced solid tumors or metastatic cancer (BioValleyBioon.com) original source: GSK Preent New Data from the GARNET Study Demontrating Potential of Dotarlimab to Treat a Subet of Women with current or Advanced Dometrial Cancer