European Commission expands Jemperli (dostarlimab) plus chemotherapy approval to all adult patients with primary advanced or recurrent endometrial cancer

Cancer research · Endometrial cancer

The primary endpoint of the study was progression‑free survival.

In this phase II trial, patients with endometrial cancer (EC) were randomized to everolimus/letrozole with (experimental arm) or without ribociclib (control arm) (ClinicalTrials.gov Identifier: NCT03008408). The primary endpoint was progression‑free survival (PFS). Secondary endpoints included toxicity, overall survival (OS), objective response rate (ORR), and clinical benefit rate (CBR). For all‑comers, there was no difference in PFS (HR 0.78, 95 % CI 0.4–1.4, p=0.38), OS (HR 0.8, 95 % CI 0.4–1.5, p=0.46), ORR (44.1 % vs 25.7 %, p=0.11), or toxicity‑related treatment discontinuation (4 [8.6 %] vs 3 [11.4 %], p=0.22). Among those with prior endocrine therapy, ORR was higher in the experimental arm (61.5 % vs 0.0 %, p<0.001). Within the experimental arm, CTNNB1_mut tumors were associated with improved PFS (HR 0.27, 95 % CI 0.1–0.7, p=0.006) and OS (HR 0.24, 95 % CI 0.1–0.7, p=0.004) compared to those with non‑CTNNB1_mut tumors.

Progression‑free survival is a standard measure of treatment efficacy in oncology trials, reflecting the duration patients remain disease‑free after therapy.

Evidence level: Korai humán adat. Kis vagy feltáró emberi adat.

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