ATIM-24. INTERIM RESULTS OF A PHASE II MULTICENTER STUDY OF THE CONDITIONALLY REPLICATIVE ONCOLYTIC ADENOVIRUS DNX-2401 WITH PEMBROLIZUMAB (KEYTRUDA) FOR RECURRENT GLIOBLASTOMA; CAPTIVE STUDY (KEYNOTE-192)
Bibliographic record
Abstract
DNX-2401 (tasadenoturev) is a replication-competent, tumor-selective, oncolytic adenovirus. A dose-escalating, Phase II study of a single intratumoral injection of DNX-2401 with pembrolizumab to determine optimal dose, safety and efficacy is ongoing and enrolling up to 48 patients with recurrent glioblastoma. Key inclusion criteria include patients with a single lesion at first or second recurrence for which resection is not possible or planned. In a dose-escalation design, a single intratumoral dose of DNX-2401 (5e8vp, 5e9vp, 5e10vp) is administered via cannula, followed 7 days later by 200 mg pembrolizumab Q3wk for up to 24 months or until confirmed progression, intolerable toxicity, or study withdrawal. Tumor response is assessed every 4 weeks for 6 months and every 8 weeks thereafter. As of 01May2018, 23 patients have been treated, with 17 at the optimal dose of 5e10vp DNX-2401. The median age and KPS at entry was 52 years (26–65) and 90 (80–100), respectively. The most frequent related grade 3–4 AEs across cohorts are headache (30%), fatigue (9%), and increased GGT (9%) consistent with disease or immune activation. Transient grade 1–3 lymphopenia has also been observed. Several cases of vasogenic edema have been managed with steroid tapers or low-dose bevacizumab. No patient has died or discontinued due to study treatment. The median treatment duration is 5.1 months for evaluable patients treated with DNX-2401 and pembrolizumab (N=15). Preliminary efficacy includes two partial responses and 100% 9-month survival for the first 7 patients treated. DNX-2401 followed by pembrolizumab is well tolerated, and data emerging for disease control and survival are encouraging. Updated results will be presented.
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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) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.002 | 0.000 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.009 | 0.003 |
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".