120MO Inupadenant combined with chemotherapy in patients with non-squamous NSCLC progressing on or after immune checkpoint inhibitor therapy: Results from dose-finding part of the A2A-005 trial
Bibliographic record
Abstract
Background: PDC*lung01 (IMP) is an innovative therapeutic cancer vaccine, synergistic with anti-PD-1, based on an irradiated plasmacytoid dendritic cell line loaded with HLA-A*02:01-restricted peptides (NY-ESO-1, MAGE-A3, MAGE-A4, Multi-MAGE-A, MUC1, Survivin and Melan-A), able to prime and expand antigen-specific CD8+ T cells in vitro and in vivo.Methods: This phase I/II study (NCT03970746) enrolled HLA-A*02 positive NSCLC pts in 4 cohorts: 2 cohorts with IMP in resected stage II/IIIA in adjuvant setting following SoC (low A1 and high dose A2) and 2 cohorts with IMP plus pembrolizumab 200 mg q3w in untreated stage IV NSCLC with PD-L150% and no targetable driver mutation (low B1 and high-dose B2).IMP was administered by SC and IV routes weekly for 6 consecutive doses.We report cohort B2 efficacy results of the 42 evaluable pts from the designed per protocol population: objective response rate (ORR) and progression-free survival (PFS).Results: At this data cut-off, the last pt reached 9 months (mo) follow-up (FU) with a median FU of 19.5mo (95%CI 13.8-25.6).Confirmed ORR was 55% (80%CI 43.7%-65.4%)reaching the predefined target (15% increase compared to Keynote-042).The 9mPFS was 49% (80%CI 38.5%;58.3%),and mature median PFS reached 8.87mo (95% CI 4.3-23.6)(Table ).An antigen-specific CD8+ T-cell response was induced in 56% of pts.Remarkable expansions of anti-tumor CD8 +T-cells up to 2.3% of total CD8+T-cells were observed.Treatment-related AEs (TRAEs) were mostly grade 1-2 with one grade 4 allergic infusion-related reaction.Fourteen pts experienced a serious AE, 3 considered related to the IMP.Conclusions: This primary analysis shows that PDC*lung01 + pembrolizumab may provide a meaningful clinical activity compared to anti-PD1 alone, with a mild safety profile.PDC*lung01 is biologically active inducing strong immune response in a significant proportion of pts.Clinical trial identification: NCT03970746.
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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) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| 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".