As one of the world's most influential oncology conferences, the European Society for Medical Oncology (ESMO) has long been dedicated to advancing global efforts in cancer research and treatment. The ESMO Congress 2025 was successfully held in Berlin, Germany, from October 17 to 21, 2025 (local time), in a hybrid format combining in-person and virtual participation. The congress showcased a wealth of cutting-edge clinical research findings and brought together leading international experts to discuss emerging trends in oncology therapeutics and patient management. Notably, multiple studies on Envafolimab® (Envafolimab Injection) were selected for presentation, highlighting its growing scientific and clinical impact.

Envafolimab® (Envafolimab Injection) demonstrating outstanding efficacy in multiple fields, bringing new benefits and expectations to patients.

中文标题：恩沃利单抗联合放化疗治疗局部晚期宫颈癌：一项前瞻性、单臂、II期研究

English Title: Envafolimab and radiochemotherapy for locally advanced cervical cancer：A prospective, single-arm, phase II study

Abstract No.: 1189P
Authors: Professor Zhou Qi et al., Chongqing University Cancer Hospital
Main Results:
This study represents the first evidence demonstrating that Envafolimab® in combination with concurrent chemoradiotherapy exhibits preliminary efficacy and a manageable safety profile in patients with locally advanced cervical cancer. As of April 20, 2025, with a median follow-up duration of 10.8 months, 32 patients were evaluable for efficacy assessment. The 1-year progression-free survival (PFS) rate was 94.4%, and the objective response rate (ORR) reached 93.8%, comprising 14 cases (43.8%) achieving complete response (CR) and 16 cases (50.0%) achieving partial response (PR). The majority of treatment-emergent adverse events (AEs) were grade 1–2, reversible, and clinically manageable. Grade ≥3 AEs included leukopenia (44.4%), neutropenia (25.0%), and anemia (8.3%).

References: Qi Z, et al. Envafolimab and radiochemotherapy for locally advanced cervical cancer: A prospective, single-arm, phase II study. 2025 ESMO, 1189P.

中文标题：恩沃利单抗联合重组人内皮抑素和化疗作为转移性胰腺癌的一项单臂探索性II期试验

English Title: Envafolimab Combined with Recombinant Human Endostatin and Chemotherapy as First - line treatment in metastatic pancreatic cancer: A single - arm, exploratory, phase II trial

Abstract No.: 2234P
Authors: Professor Han Zhengxiang et al., Affiliated Hospital of Xuzhou Medical University
Main Results: This study evaluated the efficacy and safety of Envafolimab® (a subcutaneous PD-L1 inhibitor) combined with recombinant human endostatin and AG chemotherapy (gemcitabine plus nab-paclitaxel) as first-line therapy for metastatic pancreatic cancer (mPC). As of May 6, 2025, 12 patients with mPC were evaluable for response, with a median age of 69 years (range: 28–75), including 9 males and 3 females. With a median follow-up of 9.97 months, the objective response rate (ORR) was 54.54%, and the disease control rate (DCR) was 100%. The median progression-free survival (PFS) was 8.0 months (95% CI: 6.506–9.494), while the median overall survival (OS) has not been reached. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 33.3% of patients, most commonly anemia (33.3%), thrombocytopenia (8.3%), neutropenia (16.6%), and peripheral sensory neuropathy (8.3%). No new safety signals or treatment-related deaths were reported. These preliminary findings indicate that the combination of Envafolimab®, rh-endostatin, and AG regimen demonstrates promising antitumor activity and a tolerable safety profile as first-line treatment for mPC.References: Zhengxiang Han, et al. Envafolimab Combined with Recombinant Human Endostatin and Chemotherapy as First - line treatment in metastatic pancreatic cancer: A single - arm, exploratory, phase II trial. 2025 ESMO, 2234P.

中文标题：新辅助恩沃利单抗联合放化疗治疗局部晚期癌症的探索性II期研究

English Title: Neoadjuvant envafolimab combined with chemoradiotherapy in locally advanced rectal cancer: an exploratory, phase II studyAbstract No.: 783P

Authors: Xu Guan et al.
Main Results:
Given the suboptimal pathological complete response (pCR) rates associated with standard neoadjuvant chemoradiotherapy in locally advanced rectal cancer (LARC), this study investigated the efficacy and safety of Envafolimab® combined with chemoradiotherapy. Eligible patients aged 18–60 years with histologically confirmed T3-4N0M0 or T1-4N+M0, microsatellite stable (MSS)/mismatch repair proficient (pMMR) LARC received short-course radiotherapy (25 Gy/5 fractions), followed by four cycles of Envafolimab® (300 mg) plus CapeOX (oxaliplatin 130 mg/m²; capecitabine 1000 mg/m²), and subsequent total mesorecta excision. Between October 18, 2023, and January 9, 2025, 41 patients were enrolled and treated. Among the 25 patients (61.0%) who underwent surgery, 16 (64.0%; 95% CI: 42.6–81.3) achieved pCR, and all achieved R0 resection, with a sphincter preservation rate of 68.0% (17/25). As of May 8, 2025, disease-free survival (DFS) and overall survival (OS) data remain immature. All patients experienced at least one adverse event (AE), most frequently lymphopenia (87.8%) and hypoalbuminemia (82.9%). Sixteen patients (39.0%) experienced grade ≥3 AEs, and two (4.9%) had serious adverse events (SAEs). References: Xu Guan, et al. Neoadjuvant envafolimab combined with chemoradiotherapy in locally advanced rectal cancer: an exploratory, phase II study. 2025 ESMO, 783P.

中文标题：恩沃利单抗联合放化疗治疗局部晚期鼻咽癌（NPC）的前瞻性单臂II期临床试验

English Title: Envafolimab plus chemoradiotherapy for locally advanced nasopharyngeal carcinoma (NPC), a prospective, single-armed phase II trial

Abstract No.: 1378P
Authors: Professor Wang Xiaohui, Sun Yat-sen University
Main Results:
From June 14 to December 13, 2022, 36 patients (median age: 44 years, 63.9% male) were enrolled at the Sun Yat-sen University Cancer Center in a prospective trial evaluating Envafolimab® combined with concurrent chemoradiotherapy for locally advanced nasopharyngeal carcinoma. As of May 4, 2025, the median follow-up was 28.72 months (IQR: 28.22–29.77), with both objective response rate (ORR) and disease control rate (DCR) reaching 97.2% (95% CI: 85.5%–99.9%). The 2-year progression-free survival rate was 97.2% (95% CI: 0.92–1.00). Regarding acute grade 3–4 toxicities, the combination regimen showed a favorable safety profile compared to standard therapy, with only grade 3–4 anemia exceeding 10% in incidence. These results demonstrate encouraging efficacy and improved tolerability of Envafolimab-based chemoradiotherapy. Three-year PFS outcomes are pending further follow-up.

References: Xiaohui Wang, et al. Envafolimab plus chemoradiotherapy for locally advanced nasopharyngeal carcinoma (NPC), a prospective, single-armed phase II trial 2025 ESMO, 1378P.

中文标题：恩沃利单抗和西达苯胺联合GEMOX作为晚期和转移性胆道癌的一线治疗（B-Enefits/SCOG-B001）：单臂、探索性II期试验

English Title: Envafolimab and Chidamide in combination with GEMOX as first-line treatment for advanced and metastatic biliary tract cancer (B-Enefits/SCOG-B001): A single-arm, exploratory, phase 2 trial

Abstract No.: 85P
Authors: Professor Li Wei et al., The First Affiliated Hospital of Soochow University
Main Results:
This single-arm, multicenter, prospective phase II trial assessed the efficacy and safety of Envafolimab® and Chidamide in combination with GEMOX as first-line therapy for biliary tract malignancies. A total of 35 patients were enrolled, including 29 with cholangiocarcinoma and 6 with gallbladder cancer. The objective response rate (ORR) was 51.43% (18/35), and the disease control rate (DCR) was 77.14% (27/35). Median progression-free survival (PFS) was 8.13 months (95% CI: 2.34–13.92), and median overall survival (OS) has not been reached. Grade 3–4 treatment-related adverse events (TRAEs) occurred in 68.57% of patients, primarily thrombocytopenia (48.57%), anemia (37.14%), and leukopenia (37.14%). No treatment-related deaths were recorded. Biomarker analyses revealed a significant reduction in systemic immune-inflammation index after treatment, particularly pronounced in patients achieving partial response (PR) compared to those with stable or progressive disease. Increases in circulating CD45+HLA-DR+ cells, tumor-infiltrating CD3+ and CD8+ T cells, and stromal M1-polarized macrophages were observed in the PR subgroup. These findings suggest that the Envafolimab-Chidamide-GEMOX combination exerts meaningful antitumor activity with a manageable toxicity profile in advanced biliary tract cancer.

References: Wei L, et al. Envafolimab and Chidamide in combination with GEMOX as first-line treatment for advanced and metastatic biliary tract cancer (B-Enefits/SCOG-B001): A single-arm, exploratory, phase 2 trial. 2025 ESMO, 85P.