LBA1 Final analysis of the placebo-controlled randomised phase III IMpassion031 trial evaluating neoadjuvant atezolizumab (atezo) plus chemotherapy (CT) followed by open-label adjuvant atezo in patients (pts) with early-stage triple-negative breast cancer (eTNBC)
Why this work is in the frame
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Bibliographic record
Abstract
IMpassion031 met its primary objective, significantly improving pathological complete response (pCR) rate with atezo added to neoadjuvant CT in pts with eTNBC (58% vs 41% with CT alone in the intent-to-treat [ITT] population; 17% difference, 1-sided p=0.0044) [Mittendorf 2020]. Benefit from atezo was seen regardless of PD-L1 status. Pts with untreated stage II/III eTNBC and a primary tumour >2 cm were randomised 1:1 to placebo or atezo 840 mg q2w + neoadjuvant CT (nab-paclitaxel 125 mg/m2 qw for 12 wk, then doxorubicin 60 mg/m2 + cyclophosphamide 600 mg/m2 q2w for 8 wk). After surgery, pts randomised to atezo received open-label atezo 1200 mg q3w for 11 cycles. Pts without pCR could have standard adjuvant systemic therapy (± atezo). Stratification factors were disease stage (II vs III) and PD-L1 status (IC <1% vs ≥1% by SP142). Secondary efficacy endpoints included event-free survival (EFS), disease-free survival (DFS) and overall survival (OS) in the ITT and PD-L1+ populations. After ∼39 mos’ median follow-up, EFS, DFS and OS numerically favoured atezo consistently across key clinical subgroups (Table). Among pts without pCR, 14/70 (20%) in the atezo arm vs 33/99 (33%) in the placebo arm received additional adjuvant systemic therapy, most often capecitabine (4/70 [6%] vs 26/99 [26%]). In exploratory analyses, pCR was highly prognostic for long-term outcome. Exploratory ctDNA analyses showed clearance in most pts (including all ctDNA-evaluable pts with pCR) at surgery. Positive ctDNA at/after surgery was associated with poor prognosis. There were no new safety signals or treatment-related deaths with atezo.Table: LBA1EndpointITTPD-L1+aPD-L1-expressing tumour-infiltrating immune cells on ≥1% tumour area by SP142.PlaceboAtezoPlaceboAtezoEFSEvents, n/N (%)41/168 (24)31/165 (19)17/75 (23)11/77 (14)HRbStratified.0.76 (0.47–1.21)0.55 (0.26–1.18)1 y, %91 (86–95)95 (92–98)89 (82–96)96 (92–100)2 y, %80 (74–86)85 (79–90)80 (71–89)89 (82–96)DFScIn operated pts. HR = hazard ratio.Events, n/N (%)31/153 (20)24/155 (15)11/67 (16)8/73 (11)HRbStratified.0.76 (0.44–1.30)0.57 (0.23–1.43)2 y, %83 (77–89)87 (82–93)87 (79–95)91 (85–98)OSEvents, n/N (%)28/168 (17)16/165 (10)9/75 (12)7/77 (9)HRbStratified.0.56 (0.30–1.04)0.71 (0.26–1.91)2 y, %90 (85–95)95 (91–98)91 (84–98)95 (89–100)Ranges in brackets are 95% CIs.a PD-L1-expressing tumour-infiltrating immune cells on ≥1% tumour area by SP142.b Stratified.c In operated pts. HR = hazard ratio. Open table in a new tab Ranges in brackets are 95% CIs. The significant pCR benefit with the addition of atezo to CT for eTNBC translated into numerically improved EFS, DFS and OS. Long-term safety results are consistent with previous reports.
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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) | 0.002 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.000 | 0.000 |
| 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 it