August 2023: Dostarlimab-gxly (Jemperli, GlaxoSmithKline), followed by dostarlimab-gxly as a single agent, was approved by the Food and Drug Administration for the treatment of primary advanced or recurrent endometrial cancer (EC) that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H).
RUBY (NCT03981796), randomised, multicenter, duplicatus caecus, iudicium moderatus placebo, efficacia aestimandi. Subgroup praefinitum ex 122 aegris cum primariis provectis vel recurrentibus dMMR/MSI-H EC aestimationem efficaciae subiit. Cum notitia localis deessent, probatio centralis (IHC) adhibendis Ventana MMR RxDx Panel usus est ad statum tumoris MMR/MSI aestimandum.
Patients were randomly assigned (1:1) to receive either placebo with carboplatin and paclitaxel, followed by placebo, or dostarlimab-gxly with carboplatin and paclitaxel, followed by dostarlimab-gxly. The aforementioned link provides detailed prescribing information on several chemotherapy regimens. MMR/MSI status, past external pelvic irradiation, and disease stage (recurrent, primary Stage III, or primary Stage IV) were all taken into account when stratifying the randomization process.
Investigator-assessed progression-free survival (PFS) using RECIST v. 1.1 was the main efficacy outcome measure. With a median PFS of 30.3 versus 7.7 months (Hazard Ratio=0.29 [95% CI: 0.17, 0.50]; p-value0.0001) for the dostarlimab-gxly and placebo-containing regimens, respectively, a statistically significant PFS improvement was seen in the dMMR/MSI-H group.
Pneumonitis, colitis, hepatitis, endocrinopathies such as hypothyroidism, nephritis with renal failure, and skin adverse responses are examples of immune-mediated adverse reactions that can occur with dostarlimab-gxly. Rash, diarrhoea, hypothyroidism, and hypertension were the most frequent adverse events (20%) with dostarlimab-gxly in combination with carboplatin and paclitaxel. For a complete list of side effects, refer to the prescribed information.
Dostarlimab-gxly ad doses 500 mg singulis tribus septimanis pro sex cyathis cum carboplatina et paclitaxel administranda est, deinde 1,000 mg semel in sex hebdomadibus usque ad morbum progreditur aut toxicitas intolerabilis est, quae ad tres annos capere potest. Cum chemotherapy eodem die datur, praemittenda dostarlimab-gxly.
View full praescribens informationes pro Jemperli.
