INTERLINK-1: Phase III study of cetuximab (CTX) ± monalizumab (M) in participants (pts) with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) with disease progression on/after platinum chemotherapy (CT) and previously treated with an immune checkpoint inhibitor (ICI)
Bibliographic record
Abstract
Background First-line (1L) treatment for R/M HNSCC includes ICI +/- CT or CT + CTX. Treatment after 1L failure is not clearly defined. Preliminary data suggest M (anti-NKG2A) + CTX may have clinically useful antitumour activity in R/M HNSCC. Methods In INTERLINK-1 (NCT04590963), pts with incurable R/M HNSCC (oral cavity/oropharynx/hypopharynx/larynx) were randomised 2:1 to M (750 mg IV Q2W) or placebo (P) + CTX (400 mg/m2 IV then 250 mg/m2 IV Q1W). Primary endpoint was overall survival (OS) in pts with human papillomavirus unrelated (uHPV) cancer (any non-oropharyngeal cancer [OPC] and HPV negative OPC). Secondary endpoints included OS in the full analysis set (FAS; includes uHPV and HPV positive OPC); progression-free survival (PFS) and objective response rate (ORR) in the uHPV set and FAS; and safety in all pts who received study treatment (safety analysis set [SAS]). Futility was assessed at interim analysis 1 (IA1) with 25% information fraction. Results At data cut-off (IA1 11 May 2022), 175 and 89 pts in the FAS (N=264) and 145 and 71 pts in the uHPV set (N=216) were randomised (on/before 11 March 2022) to M + CTX and P + CTX, respectively. OS hazard ratio (HR) for M + CTX vs P + CTX in the uHPV set was 1.00 (95% confidence interval [CI], 0.66–1.54; p=0.989) and in the FAS was 1.03 (95% CI, 0.70–1.53; p=0.891; Table). PFS HR was 1.11 (95% CI, 0.79–1.57) in the uHPV set and 1.11 (95% CI, 0.82–1.51) in the FAS. ORR was numerically higher with P + CTX vs M + CTX; duration of response (DoR) was similar between arms. M + CTX was tolerable. Conclusions In this incurable pt population previously treated with CT and ICI, M + CTX did not improve OS compared with P + CTX. The safety profile was acceptable. ORR with P + CTX was higher than previous reports. Clinical trial identification NCT04590963.
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 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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.003 |
| Insufficient payload (model declined to judge) | 0.008 | 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".