Introduction Dostarlimab+carboplatin-paclitaxel demonstrated PFS and OS benefits vs carboplatin-paclitaxel in patients with primary advanced or recurrent endometrial cancer (pA/rEC). Here, we report on the management of immune-related adverse events (irAEs) in the RUBY (NCT03981796) trial.
Methods Patients with pA/rEC were randomized 1:1 to dostarlimab 500 mg, or placebo, plus carboplatin AUC 5 and paclitaxel 175 mg/m2 Q3W for 6 cycles, followed by dostarlimab 1000 mg, or placebo, Q6W for up to 3 years. AEs were assessed according to CTCAE v4.03. irAEs were defined as CTCAE grade ≥2 from a predefined list.
Results The safety population included 487 patients who received ≥1 dose of treatment (241 dostarlimab+carboplatin-paclitaxel; 246 placebo+carboplatin-paclitaxel). irAEs related to dostarlimab or placebo were reported by 38.2% in the dostarlimab+carboplatin-paclitaxel arm and 15.4% in the placebo+carboplatin-paclitaxel arm; grade ≥3 irAEs related to dostarlimab or placebo were reported by 12.4% and 3.3%, respectively (table 1). Only 7.9% and 3.7% of patients discontinued dostarlimab or placebo because of an irAE, respectively; there were no irAE-related deaths. Of those experiencing irAEs in the dostarlimab+carboplatin-paclitaxel arm, 63.5% were treated with steroids, immunosuppressants, and/or thyroid therapy; 73.6% resolved (median resolution 10.0 days). Of the 36.5% patients not receiving steroids, immunosuppressants, and/or thyroid therapy, 80.0% resolved (median resolution 8.0 days). Management and resolution frequency were similar in the placebo+carboplatin-paclitaxel arm (table 1).
Conclusion/Implications In the RUBY trial, most irAEs were mild and resolved. Few patients discontinued dostarlimab because of irAEs. The irAE profile observed in the dostarlimab+carboplatin-paclitaxel arm showed similar trends as that observed with dostarlimab monotherapy.
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