Efficacy and safety of envafolimab in the treatment of advanced dMMR/MSI‑H solid tumors: A single‑arm meta‑analysis

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.