FIRST/ENGOT-OV44: A phase 3 clinical trial of dostarlimab (dost) and niraparib (nira) in first-line (1L) advanced ovarian cancer (aOC).
Bibliographic record
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%; homologous recombination-deficient [HRd] disease, 39.0%; programmed cell death ligand 1 [PD-L1]–positive tumors, 33.4% [of n=951 with nonmissing PD-L1 status]; median follow-up, 45.9 mo [IQR, 24.2–54.1]). Patient characteristics were balanced between arms. PFS was statistically significantly longer in arm 3 vs arm 2 (median PFS, 20.63 vs 19.19 mo, respectively; hazard ratio [HR], 0.85; 95% CI, 0.73–0.99; P =0.0351). PFS was reported in subgroups with PD-L1–positive tumors (HR, 0.84; 95% CI, 0.61–1.17), HRd tumors (HR, 0.95; 95% CI, 0.72–1.24), and concurrent bev use (yes: HR, 0.84; 95% CI, 0.68–1.03; no: HR, 0.86; 95% CI, 0.69–1.08).There was no statistically significant difference in overall survival (OS), a key secondary endpoint, between arms 3 and 2 (median OS, 44.39 vs 45.37 mo, respectively; HR, 1.01; 95% CI, 0.86–1.19; P =0.9060). The safety population (N=1321; arms 1–3) included 34 pts randomized to arm 1 who, upon unblinding, received arm 2 treatment; 10 randomized pts did not receive study treatment and were excluded from safety analyses. Median duration of exposure was 11.3, 15.2, and 15.2 mo in arms 1, 2, and 3, respectively. Safety results were generally consistent with the known profiles of each agent of the study. Conclusion: Adding dost to 1L PBCT and nira MT ± bev improved PFS in pts with aOC. No OS difference was observed. Clinical trial information: NCT03602859 .
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.007 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".