Pembrolizumab for advanced papillary or follicular thyroid cancer: preliminary results from the phase 1b KEYNOTE-028 study.
Bibliographic record
Abstract
6091 Background: Treatment options are limited for patients (pts) with advanced thyroid cancer. PD-L1 expression in thyroid cancer tumors has been shown to correlate with poor prognosis. Pembrolizumab (pembro), an anti–PD-1 antibody, blocks the interaction between PD-1 and PD-L1 and PD-L2. We assessed the safety and efficacy of pembro in PD-L1+ advanced (unresectable and/or metastatic) thyroid cancer. Methods: KEYNOTE-028 (NCT02054806) is a nonrandomized trial of pembro in 20 types of advanced solid tumors. Key eligibility criteria for this cohort included papillary or follicular subtypes of advanced thyroid cancer, failure of standard therapy, ECOG PS 0-1, and PD-L1 expression in ≥ 1% of tumor or stroma cells by IHC. Pembro 10 mg/kg was given every 2 wk for up to 24 mo or until confirmed progression, intolerable toxicity, death, or withdrawal of consent. Response was assessed every 8 wk for the first 6 mo and every 12 wk thereafter. The primary end point was ORR per RECIST v1.1 by investigator review. Results: Of the 22 pts enrolled, median age was 60.5 y; 40.9% were male; 68.2% vs 31.8% had papillary vs follicular carcinoma; 36.4% had an ECOG PS of 1; 50.0% received ≥ 2 prior therapies for metastatic disease (18 pts were radioactive iodine refractory; 7 pts received prior sorafenib; 1 pt received prior lenvatinib). Median follow-up duration as of Dec 10, 2015, was 73.5 wk (range, 29.4-87.0). 18 (81.8%) pts had treatment-related adverse events (TRAEs); those occurring in ≥ 15% of pts were diarrhea (n = 7) and fatigue (n = 4). 1 TRAE of grade ≥ 3 (grade 3 colitis) occurred; no pts died or discontinued pembro because of a TRAE. 2 pts had a PR for an ORR (confirmed) of 9.1% (95% CI, 1.1-29.2); median duration of response was not yet reached (range, 35.3-44.1+ wk) by the data cutoff. The stable disease rate was 54.5% (n = 12, 95% CI, 32.2-75.6). The 6-mo OS rate was 100%; the 6-mo PFS rate was 58.7%. At the data cutoff, 6 pts remained on treatment. Conclusions: Pembro shows promising antitumor activity in advanced papillary or follicular thyroid cancer which progressed on standard therapies. The clinical benefit of pembrolizumab in advanced thyroid cancer will be further investigated in the phase 2 KEYNOTE-158 trial (NCT02628067). Clinical trial information: NCT02054806.
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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 | 0.003 | 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 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 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".