Originally published by our sister publication Clinical Oncology News
By Clinical Oncology News Staff
The FDA has approved dostarlimab-gxly (Jemperli, GSK) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for adult patients with primary advanced or recurrent endometrial cancer. Dostarlimab-gxly previously was approved with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for primary advanced or recurrent endometrial cancer that is mismatch repair–deficient (dMMR) or microsatellite instability-high (MSI-H).
Efficacy was evaluated in RUBY (ClinicalTrials.gov. Identifier: NCT03981796), a randomized, multicenter, double-blind, placebo-controlled trial conducted in 494 patients with primary advanced or recurrent endometrial cancer. Patients were randomized (1:1) to either dostarlimab-gxly with carboplatin and paclitaxel, followed by dostarlimab-gxly, or placebo with carboplatin and paclitaxel, followed by placebo. Chemotherapy regimens are described in the below link for the full prescribing information. Randomization was stratified by MMR)/MSI status, prior external pelvic radiotherapy and disease status (recurrent, primary stage III or primary stage IV).
The major efficacy outcome measures were progression-free survival (PFS) (investigator-assessed using RECIST [Response Evaluation Criteria in Solid Tumors] version 1.1) in the dMMR/MSI-H and overall populations and overall survival (OS) in the overall population. In the overall population, a statistically significant OS improvement was observed with a median OS of 44.6 months (95% CI, 32.6 months to not reached) and 28.2 months (95% CI, 22.1-35.6 months) in the dostarlimab-gxly and placebo arms, respectively (hazard ratio, 0.69; 95% CI, 0.54-0.89; one-sided P=0.002). Median PFS in the overall population was 11.8 months (95% CI, 9.6-17.1 months) and 7.9 months (95% CI, 7.6-9.5 months) in the dostarlimab-gxly and placebo arms, respectively (hazard ratio, 0.64; 95% CI, 0.51-0.80; one-sided P<0.0001).
The most common adverse reactions (≥20%) with dostarlimab-gxly with carboplatin and paclitaxel were anemia, increased creatinine, peripheral neuropathy, decreased white blood cell count, fatigue, nausea, alopecia, low platelets, increased glucose, lymphopenia, neutropenia, liver function test abnormalities, arthralgia, rash, constipation, diarrhea, decreased albumin, abdominal pain, dyspnea, decreased appetite, increased amylase, urinary tract infection and vomiting. Immune-mediated adverse reactions with dostarlimab-gxly were similar to those previously reported for dostarlimab-gxly. See the dostarlimab-gxly full prescribing information for complete adverse reactions.
The full prescribing information for dostarlimab-gxly is posted here.
Based on a press release from the FDA.
