First-line lenvatinib plus pembrolizumab versus chemotherapy for advanced endometrial cancer: 1-Year follow-up after final analysis of the ENGOT-en9/LEAP-001 phase 3 trial
Bibliographic record
Abstract
OBJECTIVE: The phase 3 ENGOT-en9/LEAP-001 trial (NCT03884101) comparing first-line lenvatinib+pembrolizumab with carboplatin+paclitaxel did not meet pre-specified statistical criteria for overall survival or progression-free survival in participants with advanced/recurrent endometrial cancer. We report results after an additional year of follow-up (overall median 54.5 [range; 46.5-69.0] months). METHODS: Eligible participants were adult females with stage III to IV or recurrent, histologically confirmed endometrial cancer. Measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and radiographically apparent disease per blinded independent central review was required. Participants were randomly allocated 1:1 to lenvatinib+pembrolizumab or chemotherapy (paclitaxel+carboplatin). The primary end points were overall survival and progression-free survival per RECIST version 1.1 by blinded independent central review. Secondary end points included objective response rate per RECIST version 1.1 by blinded independent central review and safety. RESULTS: The median overall survival (95% confidence interval [CI]) was 30.9 (range; 25.4-37.6) months with lenvatinib+pembrolizumab versus 29.4 (range; 26.2-34.8) months with chemotherapy in mismatch repair-proficient endometrial cancer (hazard ratio [HR] 0.99, 95% CI 0.82 to 1.21), 37.9 (range; 32.2-43.0) versus 32.3 (range; 27.2-35.7) months in all-comers (HR 0.91, 95% CI 0.77 to 1.09), and not reached in either treatment group in mismatch repair-deficient endometrial cancer (HR 0.60, 95% CI 0.39 to 0.93]). Corresponding results for progression-free survival were 9.6 (range; 8.2-11.9) versus 10.2 (range; 8.4-10.5) months (HR 1.01, 95% CI 0.83 to 1.22), 12.5 (range; 10.3-15.1) versus 10.2 (range; 8.4-10.4) months (HR 0.92, 95% CI 0.77 to 1.10]), and 31.8 (22.5 to not reached) versus 9.0 (range; 8.2-17.1) months (HR 0.62, 95% CI 0.41-0.93). Objective response rates were 50.6% versus 54.7%, 55.7% versus 55.5%, and 72.0% versus 58.0%, respectively. No new safety signals were identified. The results were consistent with those at the final analysis. CONCLUSIONS: The mismatch repair-proficient, all-comer, and mismatch repair-deficient populations continued to demonstrate antitumor activity for lenvatinib+pembrolizumab after an additional year of follow-up. These results should be interpreted with caution due to the exploratory nature of the analysis. TRIAL REGISTRATION: ClinicalTrials.gov No. NCT03884101.
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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 | 0.007 | 0.005 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.003 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.004 |
| Insufficient payload (model declined to judge) | 0.006 | 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".