INDUCE-3: A Randomized Phase II/III Study of First-line Feladilimab plus Pembrolizumab in Patients with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Bibliographic record
Abstract
PURPOSE: Feladilimab, an inducible T-cell costimulatory receptor agonist, demonstrated clinical activity in combination with pembrolizumab in a phase I head and neck squamous cell carcinoma (HNSCC) expansion cohort, prompting further evaluation in patients in this setting. PATIENTS AND METHODS: INDUCE-3 (NCT04128696) was a randomized, double-blind, phase II/III study in patients with first-line PD-L1-positive recurrent and/or metastatic HNSCC. A 2-in-1 adaptive design was implemented, with an option to expand the phase II study into a phase III confirmatory study. Patients were randomized 1:1 to receive feladilimab plus pembrolizumab or placebo plus pembrolizumab, with up to 35 cycles of treatment for approximately 2 years. Primary endpoints were overall survival (OS) and investigator-assessed progression-free survival (PFS). RESULTS: The study enrolled 315 patients. Following the review of unblinded interim data in 140 patients, an Independent Data Monitoring Committee recommended stopping patient accrual based on prespecified criteria. Existing patients discontinued feladilimab or placebo. Pembrolizumab treatment continued until prespecified stopping criteria were met. This study demonstrated no evidence of an effect in favor of feladilimab plus pembrolizumab, with an adjusted HR of 1.51 for OS and 1.40 for PFS (median OS: 44.1 weeks [95% confidence interval (CI), 35.9-not applicable]; median PFS: 10.1 weeks [95% CI, 9.1-15]) versus placebo plus pembrolizumab [median OS: not reached; median PFS: 16 weeks (95% CI, 14.3-26.1)]. The incidence of treatment-related adverse events was higher in the placebo group. CONCLUSIONS: This analysis does not support the combination of feladilimab plus pembrolizumab due to a lack of superiority over placebo plus pembrolizumab.
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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 | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.003 |
| Insufficient payload (model declined to judge) | 0.004 | 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".