FIRST/ENGOT-OV44: A phase 3 clinical trial of dostarlimab (dost) and niraparib (nira) in first-line (1L) advanced ovarian cancer (aOC)
Abstract
LBA5506
Background:
The FIRST/ENGOT-OV44 trial evaluated adding dost, a programmed cell death protein-1 inhibitor, to 1L platinum-based chemotherapy (PBCT) and nira maintenance (MT) ± bevacizumab (bev) in patients (pts) with aOC.
Methods:
In this randomized, double-blind, phase 3 trial, pts with newly diagnosed stage III–IV, high-grade nonmucinous epithelial OC received 1-cycle run-in of PBCT ± bev and were randomized (1:1:2) to arm 1 (PBCT+placebo [PBO] with PBO MT), arm 2 (PBCT+PBO with nira+PBO MT), or arm 3 (PBCT+dost with dost+nira MT). Stratification factors included intended bev use (yes/no), homologous recombination repair (HRR) mutation status (
BRCA
-mutated;
BRCA
wild-type HRR-positive;
BRCA
wild-type HRR-negative/not determined), and stage III disease with postoperative residual disease <1 cm (yes/no). After approvals for 1L MT poly(ADP-ribose) polymerase inhibitors, arm 1 enrollment closed, and pts were randomized (1:2) to arms 2 or 3. The primary endpoint was investigator-assessed progression-free survival (PFS) per RECIST v1.1, assessed in arms 2 and 3, and analyzed per randomized treatment. Safety was assessed among pts who received ≥1 dose of study treatment and analyzed per treatment received. The data cutoff was October 31, 2024.
Results:
Randomization was from 14Nov2018 to 05Jan2021. Efficacy analyses included 1138 randomized pts (arm 2, n=385; arm 3, n=753; stage IV disease at diagnosis, 37.3%; planned interval surgery, 54.6%; inoperable, 9.8%;…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 1,321 participants or records.
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