2023 Ágúst: 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), slembiraðað, fjölsetra, tvíblind, samanburðarrannsókn með lyfleysu, metin verkun. Fyrirfram ákveðinn undirhópur 122 sjúklinga með upphaflega langt gengið eða endurtekið dMMR/MSI-H EC fór í mat á verkun. Þegar staðbundin gögn voru ekki tiltæk var miðlæg prófun (IHC) með Ventana MMR RxDx Panel notuð til að meta MMR/MSI æxlisstöðu.
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.
Gefa á Dostarlimab-gxly í 500 mg skammti á þriggja vikna fresti í sex skammta af karbóplatíni og paklítaxeli, síðan 1,000 mg einu sinni á sex vikna fresti þar til sjúkdómurinn versnar eða óþolandi eiturverkanir verða, sem gætu tekið allt að þrjú ár. Þegar dostarlimab-gxly er gefið sama dag og krabbameinslyfjameðferð á að gefa fyrst.
Skoðaðu allar ávísunarupplýsingar fyrir Jemperli.
