ATIM-35. RESULTS OF THE PHASE IB KEYNOTE-028 MULTI-COHORT TRIAL OF PEMBROLIZUMAB MONOTHERAPY IN PATIENTS WITH RECURRENT PD-L1-POSITIVE GLIOBLASTOMA MULTIFORME (GBM)
Bibliographic record
Abstract
Patients with recurrent GBM have limited treatment options and poor clinical outcome. Tumors, including GBM, use the PD-1 pathway to evade immune responses. KEYNOTE-028 (NCT02054806) evaluated the safety and efficacy of the anti–PD-1 monoclonal antibody pembrolizumab in 20 advanced solid tumor types. Results of the GBM cohort (N=26) are presented. Key inclusion criteria included advanced (unresectable and/or metastatic) bevacizumab-naive GBM, failure of or inability to receive standard therapy, ECOG PS 0-1, and PD-L1 expression in ≥1% of tumor or stroma cells by immunohistochemistry. Patients received pembrolizumab 10 mg/kg every 2 weeks for up to 24 months or until confirmed progression, intolerable toxicity, death, withdrawal of consent, or physician decision. Response was assessed every 8 weeks for the first 6 months and every 12 weeks thereafter. The primary end point was ORR per RECIST v1.1 by investigator review. Median age was 55.5 years; 53.8% were male; 53.8% had an ECOG PS of 1; all had received prior chemotherapy. As of the February 17, 2016, data cutoff date, median follow-up duration was 60.9 weeks (range, 11.7-94.0) and 22 (84.6%) patients had discontinued pembrolizumab. Treatment-related AEs occurred in 19 (73.1%) patients, most commonly fatigue and rash (n=6 each, 23.1%). Four (15.4%) patients experienced grade 3-4 treatment-related AEs (lymphopenia, type 2 diabetes mellitus, arthritis, and syncope). No patients died or discontinued pembrolizumab because of a treatment-related AE. There was 1 partial response (n=25; ORR, 4.0% [95% CI, 0.1-20.4]); an additional 12 (48.0%) patients experienced stable disease (SD). Median duration of SD was 39.4 weeks (range, 7.1+-85.9+). Median PFS was 2.8 months (95% CI, 1.9-9.1); median OS was 14.4 months (95% CI, 10.3-not reached). Treatment with pembrolizumab monotherapy was associated with a manageable safety profile, and consistent with that of other PD-1 agents, promising antitumor activity in patients with recurrent GBM.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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 teacher head, 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".