Efficacy and safety of envafolimab in the treatment of advanced dMMR/MSI‑H solid tumors: A single‑arm meta‑analysis
Bibliographic record
Abstract
In November 2021, the National Medical Products Administration (China) approved the marketing of envafolimab injection for the treatment of advanced defective mismatch repair (dMMR)/high microsatellite instability (MSI‑H) solid tumors. Envafolimab became the first domestic PD‑L1 inhibitor approved in China and the first worldwide approved subcutaneously injectable PD‑L1 inhibitor. To the best of our knowledge, there are no reports of systematic analyses regarding the use of envafolimab in the treatment of advanced dMMR/MSI‑H solid tumors. The present study was a single‑arm meta‑analysis performed on data systematically searched and retrieved from literature published on PubMed, Web of Science, Cochrane Library, China National Knowledge Infra‑structure and Wan Fang databases on 1 October 2022. Quality assessment using the 20 items developed by the Canadian Institute of Health Economics. Data heterogenicity was evaluated using the I2 statistics. For datasets with I2>50%, the cumulative incidence and 95% CI for the outcomes of interests were calculated using the random effects model, whereas for I2<50% the fixed effects model was used. The current meta‑analysis included four studies enrolling 181 patients with advanced dMMR/MSI‑H solid tumors. The pooled objective remission rate was 29.53% (95% CI, 8.61‑50.45%). The pooled disease control rate was 60.58% (95% CI, 31.79‑89.38%). The pooled median progression‑free survival was 4.89 months (95% CI, 1.86‑7.93 months). The pooled overall survival (OS) rate was 73.38% (95% CI, 65.76‑80.99%). The pooled 6‑month and 12‑month OS rates were 75.80% (95% CI, 57.02‑94.58%) and 69.32% (95% CI, 51.92‑86.72%), respectively. The combined data on the incidence of treatment‑emergent adverse events (TEAEs) of any grade from all the studies was 77.19% (95% CI, 63.15‑91.23%). Most of the adverse reactions were mild and the rate of 3/4 grade TEAE was 10.37% (95% CI, 6.14‑14.60%). Gevokizumab was effective and safe in the treatment of patients with advanced dMMR/MSI‑H solid tumors and its convenience could significantly improve patient compliance; therefore, the clinical application of envafolimab is promising.
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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 | 0.017 | 0.022 |
| Meta-epidemiology (narrow) | 0.004 | 0.002 |
| Meta-epidemiology (broad) | 0.018 | 0.060 |
| Bibliometrics | 0.004 | 0.004 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.004 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.004 | 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".