Antitumor activity and safety of pembrolizumab in patients with advanced recurrent ovarian cancer: Interim results from the phase 2 KEYNOTE-100 study.
Bibliographic record
Abstract
5511 Background: Data from the KEYNOTE-028 study (NCT02054806) suggested that pembrolizumab (pembro) has clinical activity in patients (pts) with PD-L1+ advanced ovarian cancer (AOC). We assessed the antitumor activity and safety of pembro in pts with recurrent AOC in the ongoing, 2-cohort, phase 2 KEYNOTE-100 study (NCT02674061). Methods: Key eligibility criteria included epithelial ovarian, fallopian tube, or primary peritoneal cancer, confirmed recurrence following front-line platinum-based therapy, ECOG PS 0/1, and provision of a tumor sample for biomarker analysis. Cohort A pts received ≤2 prior chemotherapy lines for recurrent AOC and had a platinum-free or treatment-free interval (PFI/TFI) of ≥3 to 12 mo. Cohort B pts received 3-5 prior chemotherapy lines and had a PFI/TFI of ≥3 mo. Pts received pembro 200 mg Q3W IV for 2 yrs or until progression, death, unacceptable toxicity, or consent withdrawal. Tumor imaging was performed every 9 wks for 1 yr and every 12 wks thereafter. Primary study endpoint was ORR per RECIST v1.1 by independent central review for both cohorts and by tumor PD-L1 expression. The effect of PD-L1 expression on ORR was tested with the combined positive score (CPS) assay. Cutpoints were established using the first 100 pts enrolled into Cohort A (training set). Validation was performed among all subsequent pts enrolled. Training set results are presented here. Complete results (n = 378) will be available for presentation. Results: 378 pts were enrolled in KEYNOTE-100. 97/100 training set pts had analyzable results. Mean (±SD) age for this group was 61 (±12) yr, 68% had ECOG PS 0, and 77% had high grade serous disease. ORR was 9% (95% CI, 4, 17). ORR was higher in pts with PD-L1 expression: 14% (8/59) with CPS ≥1 and 25% (5/20) with CPS ≥10. 73% of pts had treatment-related (TR) AEs and 17% had grade 3-5 TR AEs. There was 1 TR death in a pt with Stevens-Johnson syndrome. Conclusions: Pembro monotherapy was associated with antitumor activity in pts with recurrent AOC. ORR increased with PD-L1 expression, better defining a population benefiting from single agent pembro. No new safety signals were identified in this population. Clinical trial information: NCT02674061.
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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 | 0.005 | 0.003 |
| 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 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 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".