Updated safety and clinical activity of durvalumab monotherapy in previously treated patients with stage IIIB/IV NSCLC.
Bibliographic record
Abstract
9085 Background: Preliminary analyses of an ongoing Phase 1/2 study of single-agent durvalumab showed antitumor activity and a tolerable safety profile in advanced NSCLC, with higher ORR and longer OS in pts with high vs. low/negative PD-L1 tumor expression. Here we present updated safety analyses (primary endpoint) for all NSCLC pts and clinical activity based on investigator-assessed RECIST v1.1 in pts who had received prior treatment for advanced NSCLC. Methods: Durvalumab (10 mg/kg q2w) was given until unacceptable toxicity or disease progression, or for up to 12 mos; retreatment was permitted upon disease progression after completion of 12 mos of treatment. PD-L1 expression was assessed using the Ventana PD-L1 (SP263) Assay (PD-L1 high = ≥25% and PD-L1 low/negative = <25% of tumor cells with membrane staining). Results: As of 24 Oct 2016, 245 pts with previously treated NSCLC (53% squamous) received durvalumab and were followed for a median of 29.2 (range 0.3–40.5) mos; 142 pts (58%) had treatment-related adverse events (AEs), most frequent: fatigue (18%), decreased appetite (9%), and nausea, rash, and diarrhea (each 8%). 25 pts (10%) had treatment-related Grade 3/4 AEs, most frequent: fatigue and hyponatremia (each 2%); there were no treatment-related deaths. 4% had treatment-related serious AEs including colitis and pneumonitis (each 2%). In the overall population, 12 mo OS rate was 47% (95% CI 40–53) and 18 mo OS rate was 38% (95% CI 31–45). Antitumor activity and survival by PD-L1 status are shown in the table. Conclusions: Consistent with earlier reports, durvalumab had a manageable safety profile in Stage IIIB/IV NSCLC, with encouraging clinical activity as 2L+ therapy. Higher tumor PD-L1 expression enriched clinical benefit of response rate and survival endpoints. Clinical trial information: NCT01693562. [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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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".