Abstract CT115: Updated survival results of the KEYNOTE-040 study of pembrolizumab vs standard-of-care chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma
Bibliographic record
Abstract
Abstract Background: It was known that survival data were outstanding on several patients (pts) when the final analysis of the multinational, open-label, phase 3 KEYNOTE-040 study (NCT02252042) of pembro vs SOC for recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) was performed. This abstract presents OS and PFS data using the same data cutoff date but with full survival acquisition. Methods: 495 pts with SCC of the oral cavity, oropharynx, hypopharynx, or larynx who had recurrence or PD after a platinum-containing regimen were randomized 1:1 to pembro 200 mg Q3W for 24 mo or investigator's choice of methotrexate, docetaxel, or cetuximab. Primary end point was OS in the ITT population. Key secondary end points included OS in the PD-L1 combined positive score (CPS) ≥1 population and PFS in the ITT and CPS ≥1 populations. OS and PFS in the PD-L1 tumor proportion score (TPS) ≥50% population were prespecified exploratory end points. Response was assessed per RECIST v1.1 by blinded, independent central review. Results: With full acquisition of survival data, HR was 0.80 (95% CI, 0.65-0.98) (nominal P = 0.0161) for OS and 0.96 (95% CI, 0.79-1.16) (nominal P = 0.33) for PFS in the ITT population. Median (95% CI) OS was 8.4 mo (6.4-9.4) for pembro vs 6.9 mo (5.9-8.0) for SOC; median PFS was 2.1 mo (2.1-2.3) vs 2.3 mo (2.1-2.8). Pembro benefit was greater in pts with PD-L1 CPS ≥1 and TPS ≥50% (Table). Conclusions: Pembro provided a clinically meaningful prolongation of OS compared with SOC in pts with R/M HNSCC. With full acquisition of survival data and compared with the previous analysis, the HR for OS decreased from 0.81 to 0.80, and the P value decreased from 0.0204 to 0.0161. There continued to be an enhanced benefit for pembro in pts with PD-L1–expressing tumors. Along with previously presented safety data, these results provide stronger support for the benefit of pembro in pts with R/M HNSCC. Table. OS and PFS in the PD-L1 CPS ≥1 and TPS ≥50% Populations CPS ≥1TPS ≥50%Pembron = 196SOCn = 191Pembro n = 64SOCn = 65OSMedian (95% CI), mo8.7 (6.9-11.4)7.1 (5.7-8.3)11.6(8.3-19.5)6.6(4.8-9.2)HR (95% CI)0.74 (0.58-0.93)0.53 (0.35-0.81)Pa0.00490.0014PFSMedian (95% CI), mo2.2 (2.1-3.0)2.3 (2.1-3.0)3.5(2.1-6.3)2.1(2.0-2.4)HR (95% CI)0.86 (0.69-1.06)0.58 (0.39-0.86)Pa0.080.003aNominal one-sided P value stratified by the randomization stratification factors. Citation Format: Denis Soulieres, Ezra Cohen, Christophe Le Tourneau, Jose Dinis, Lisa Licitra, Myung-Ju Ahn, Ainara Soria, Jean-Pascal Machiels, Nicolas Mach, Ranee Mehra, Barbara Burtness, Pingye Zhang, Jonathan Cheng, Ramona Swaby, Kevin J. Harrington. Updated survival results of the KEYNOTE-040 study of pembrolizumab vs standard-of-care chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr CT115.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| 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".