Efficacy and safety of lenvatinib (LEN) plus pembrolizumab (PEMBRO) versus sunitinib (SUN) in the East Asian subset of patients with advanced renal cell carcinoma (aRCC) from the phase 3 CLEAR trial.
Bibliographic record
Abstract
338 Background: In the phase 3 CLEAR trial that included patients with aRCC, LEN + PEMBRO demonstrated significant improvements in progression-free survival (PFS; hazard ratio [HR] 0.39; 95% CI 0.32, 0.49; P < 0.001), overall survival (OS; HR 0.66; 95% CI 0.49, 0.88; P = 0.005) and objective response rate (ORR; odds ratio 4.35; 95% CI 3.16, 5.97) vs SUN. Here we report the efficacy and safety results of the East Asian population subset of the CLEAR trial. Methods: Patients with aRCC and no prior systemic therapy were randomized (1:1:1) to receive 1 of 3 treatments including LEN 20 mg PO QD + PEMBRO 200 mg IV Q3W and SUN 50 mg PO QD (4 weeks on/2 weeks off). Randomization was stratified by geographic region and MSKCC prognostic groups. This analysis compares the efficacy and safety of LEN + PEMBRO vs SUN in the East Asian subset of the CLEAR trial including patients from Japan and the Republic of Korea. The primary endpoint was PFS; secondary endpoints included OS, ORR and safety. An independent review committee assessed tumors per RECIST v1.1. Median PFS and OS were calculated using the Kaplan-Meier method; HR and 95% CI were estimated by a stratified Cox model. Odds ratios were estimated by a stratified Cochran-Mantel-Haenszel test. Results: Of the 1069 patients randomized, 75 patients in the LEN + PEMBRO group and 65 patients in the SUN group were from East Asia. PFS was improved with LEN + PEMBRO vs SUN (median 22.1 vs 11.1 mo; HR 0.38, 95% CI 0.23, 0.62). Median OS was not reached for both arms; the HR for OS comparing LEN + PEMBRO vs SUN was 0.71, 95% CI 0.30, 1.71. ORR was improved with LEN + PEMBRO vs SUN (65.3% vs 49.2%; odds ratio 2.14, 95% CI 1.07, 4.28). Grade ≥3 treatment emergent adverse events (TEAEs) occurred in 88.0% of patients in the LEN + PEMBRO group and in 79.7% of patients in the SUN group. The incidences and types of TEAEs were generally similar to the overall CLEAR population and were manageable with dose adjustments and appropriate concomitant therapies. Conclusions: Efficacy results for patients in the East Asian subset of the CLEAR trial were consistent with the results of the overall population. The safety profile of LEN + PEMBRO in the East Asian subset was also generally consistent with that of the overall population. Clinical trial information: NCT02811861. [Table: see text]
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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 | 0.004 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.002 | 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 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".