Ağustos 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), randomize, çok merkezli, çift kör, plasebo kontrollü bir çalışma, etkililiği değerlendirdi. Birincil ilerlemiş veya tekrarlayan dMMR/MSI-H EC'li 122 hastadan oluşan önceden belirlenmiş bir alt grup, bir etkinlik değerlendirmesine tabi tutuldu. Yerel veriler mevcut olmadığında, MMR/MSI tümör durumunu değerlendirmek için Ventana MMR RxDx Panel kullanan merkezi test (IHC) kullanıldı.
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, karboplatin ve paklitaksel ile birlikte altı doz olmak üzere üç haftada bir 500 mg'lık bir dozda, ardından hastalık ilerleyene veya üç yıla kadar sürebilecek dayanılmaz bir toksisite oluşana kadar altı haftada bir 1,000 mg'lık bir dozda uygulanmalıdır. Kemoterapi ile aynı gün verildiğinde önce dostarlimab-gxly verilmelidir.
Jemperli için tam reçete bilgilerini görüntüleyin.
