Enweida (envafolimab) / 3DMed, Alphamab, Simcere, Ascletis, Glenmark - LARVOL DELTA

Envafolimab consolidation therapy after chemoradiotherapy in Stage III, Unresectable NSCLC: Preliminary results from a prospective, single-arm, phase II trial (ESMO Asia 2025) - P2 | "The results of this study indicate that envafolimab, when used as consolidation therapy in patients with stage III NSCLC who have not experienced disease progression after concurrent or sequential chemoradiotherapy, demonstrates encouraging efficacy and a tolerable safety profile. These findings provide evidence supporting the use of envafolimab as consolidation therapy for patients with unresectable stage III NSCLC who remain progression-free following concurrent or sequential chemoradiotherapy."

Clinical • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Adjuvant envafolimab combined with capecitabine and lenvatinib versus conventional therapy in resected biliary tract cancer with high-risk recurrence factors: A propensity score-matched analysis (ESMO Asia 2025) - P2/3 | "The adjuvant ECL regimen significantly improved DFS and 1-year OS rate compared to CT in resected BTC patients with high-risk recurrence factors. These promising results warrant further validation in randomized controlled trials to establish its potential as a new standard adjuvant therapy."

Clinical • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

Envafolimab (anti-PD-L1) as monotherapy or in combination with CAPEOX for neoadjuvant treatment of locally advanced colon cancer: A prospective, single-center, dual-cohort clinical trial (NCT06014372) (ESMO Asia 2025) - P2 | "Subcutaneous envafolimab induced marked tumour regression with acceptable safety in locally advanced colon cancer. In MSS/pMMR patients, envafolimab plus CAPEOX showed promising efficacy and high completion rates, supporting further study in this subgroup."

Clinical • Combination therapy • Metastases • Monotherapy • Colon Cancer • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor • MSI

Safety and Efficacy Analysis of Oral Etoposide Combined With Anlotinib and Envafolimab in First-line Treatment of Elderly Patients With Small Cell Lung Cancer/ Open-label, Single-arm, Exploratory Phase II Clinical Study (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting ➔ Active, not recruiting | Trial completion date: May 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2025

Enrollment closed • Trial completion date • Trial primary completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Clinical Trial of Envafolimab Combined With Lenvatinib for Kidney Cancer With Liver Spread (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Fudan University

New P2 trial • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

EXCEPTIONAL RESPONSE TO COMBINATION IMMUNOTHERAPY WITH YH001 AND ENVAFOLIMAB IN METASTATIC SARCOMA. (CTOS 2025) - "Data from a group of patients at a single institution enrolled in a prematurely discontinued clinical trial are presented, focusing on one patient who showed an exceptional response. This discontinued phase 1/2 open-label study was designed to investigate the combination of YH001 (recombinant humanized anti-CTLA-4 IgG1 monoclonal antibody) and envafolimab (KN035, an anti-PD-L1 agent approved in China) in advanced sarcomas. A sustained disease response was identified in a patient with metastatic fibrosarcoma refractory to chemotherapy and TKI, after PD-L1/CTLA-4 treatment, underscoring potential for combined immunotherapeutics in sarcoma and the need for predictive biomarker identification beyond TMB and PD-L1."

IO biomarker • Metastases • Tumor mutational burden • Fibrosarcoma • Leiomyosarcoma • Liposarcoma • Oncology • Sarcoma • Solid Tumor • Synovial Sarcoma • TMB

Rare MSI-H hepatoid adenocarcinoma of the colon with BRAF V600E mutation achieving long-term disease-free survival after adjuvant envafolimab: a case report. (PubMed, Front Immunol) - "Comprehensive molecular profiling can help guide personalized immunotherapy decisions. Further studies are needed to confirm long-term benefits, optimize treatment duration and dosing, and identify predictive biomarkers for high-risk CRC."

IO biomarker • Journal • MSI-H • Tumor mutational burden • Colon Adenocarcinoma • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Genetic Disorders • Hematological Disorders • Microsatellite Instability • Oncology • Solid Tumor • BRAF • MLH1 • MSH6 • MSI • PMS2 • TMB

Efficacy and safety of PD-L1 blockade envafolimab as neoadjuvant treatment in mismatch repair-deficient, locally advanced colorectal cancer: An open-label, single-arm study. (PubMed, Cancer) - "This preliminary study suggests that envafolimab is a promising effective and safe neoadjuvant option for locally advanced dMMR CRC; confirmation in larger cohorts is awaited."

dMMR • Journal • Mismatch repair • Colorectal Cancer • Oncology • Solid Tumor • PD-L1

Adverse events induced by the subcutaneous HER2-targeted antibody-drug conjugate JSKN033 in a male patient with breast cancer: A case report. (PubMed, Oncol Lett) - "JSKN033 is a fixed-dose combination of JSKN003 [a biparatopic HER2-directed antibody-drug conjugate (ADC)] and envafolimab (a programmed death-ligand 1 inhibitor)...The present report highlights the case of a male patient with breast cancer with HER2 2+ expression who experienced disease progression after multiline therapy, including modified radical mastectomy, adjuvant chemotherapy, adjuvant radiotherapy and trastuzumab emtansine. Following enrollment in the JSKN033 clinical trial, the patient developed systemic and localized adverse reactions after treatment, including fatigue, diarrhea and injection-site reactions, such as pruritus, pain, skin indentation and induration. The present case report discusses potential etiologies of these adverse events and issues to consider during subcutaneous administration of HER2-directed ADCs, and provides supplementary clinical data to potentially advance the understanding of their adverse event profiles, mechanisms, prevention and..."

Adverse events • Journal • Breast Cancer • Dermatology • Fatigue • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Pain • Pruritus • Solid Tumor

Efficacy and Safety of Neoadjuvant Envafolimab Combined With Albumin-bound Paclitaxel and Carboplatin for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=26 | Recruiting | Sponsor: Shanghai Zhongshan Hospital

New P2 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

A Phase I Study to Investigate the Safety and Tolerability of KGX101 Monotherapy and Combination Therapy With Envafolimab in Advanced or Metastatic Solid Tumor Patients (clinicaltrials.gov) - P1 | N=57 | Recruiting | Sponsor: Kangabio AUSTRALIA LTD PTY

Monotherapy • New P1 trial • Solid Tumor • IL12A

Efficacy and Safety of Envafolimab Plus Doxorubicin and Ifosfamide for Advanced Soft Tissue Sarcoma (clinicaltrials.gov) - P2 | N=15 | Not yet recruiting | Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

New P2 trial • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Clear Cell Sarcoma of the Perineum in a Young Woman and Diagnosis and Management Challenges—A Case Report and a Literature Review (COSA 2025) - "The patient received anlotinib as the first-line therapy and envafolimab combining with Lenvatinib as the second-line... Between CCS and malignant melanoma, differential diagnosis is exceedingly important by molecular genetics tests. Our observations suggest that target therapy combined with immunotherapy may be a promising treatment option for locally advanced or metastatic CCS."

Case report • Clinical • IO biomarker • Review • Melanoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • ATF1 • EWSR1

Hepatoid Adenocarcinoma of the Stomach Combined With Gastric Neuroendocrine Carcinoma: A Case Report. (PubMed, Clin Case Rep) - "Initially, he received EP chemotherapy, which was subsequently switched to a regimen of capecitabine plus oxaliplatin due to insufficient therapeutic response...However, in this case, the treatment with Lenvatinib plus Envafolimab appears to be an effective strategy for prolonging survival time and improving quality of life. Further experimental and clinical investigations are warranted to validate these findings and substantiate this therapeutic hypothesis."

Journal • Endocrine Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Neuroendocrine Carcinoma • Neuroendocrine Carcinoma • Oncology • Solid Tumor

Subcutaneously administered anti-PD-(L)1 antibodies are predominantly absorbed via the lymphatic system, resulting in high drug exposure to draining lymph nodes. (PubMed, J Pharm Sci) - "The current study aimed to examine the absorption route of widely used anti-PD-(L)1 mAbs following SC injection, and four marketed products (Pembrolizumab, Tislelizumab, Envafolimab, Sugemalimab) were selected as the model drugs...In addition, markedly different lymphatic absorption profiles were observed following SC administration at different sites, reflecting specific draining routes associated with certain anatomical regions in the rat. Our data suggested that the food pad is likely the optimal SC injection site for quantitative studies of lymphatic transport, whereas injection to the lower hind leg (a common SC injection site in previous studies) appeared to underestimate the absolute extent of lymphatic drug transport in the thoracic lymph-duct cannulated rat model, as these sites are drained by lymphatic networks that cannot be fully captured by the thoracic lymph-duct cannulation model."

Journal

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 II trial (ESMO 2025) - P2 | "Methods Patients with advanced BTCs received treatment of envafolimab (400 mg, day 1), chidamide (20 mg, day 0, 3, 7, and 10), and GEMOX (gemcitabine 1000 mg/m 2 , day 1 and 8, oxaliplatin 100 mg/m 2 , day 1) every 3 weeks for 8 cycles...Conclusions The novel combination of envafolimab, chidamide, and GEMOX demonstrated clinically meaningful antitumor activity with manageable toxicity in patients with advanced BTC. Legal entity responsible for the study The authors."

Clinical • Combination therapy • Metastases • P2 data • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Oncology • Solid Tumor • CD8 • PTPRC

Preliminary results of a randomized phase II trial evaluating envafolimab, etoposide, and carboplatin with or without trilaciclib in ES-SCLC (ESMO 2025) - P2 | "Reduced severe hematologic toxicity in Cohort A supports trilaciclib's myelopreservation benefits. Ongoing follow-up will assess long-term outcomes."

Clinical • P2 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • IL10 • IL6

Envafolimab plus chemoradiotherapy for locally advanced nasopharyngeal carcinoma (NPC), a prospective, single-armed phase II trial (ESMO 2025) - P2 | "Background Although Immune checkpoint blockade therapy combined with gemcitabine and cisplatin(GP) has been shown to improve survival in recurrent or metastatic nasopharyngeal carcinoma (NPC), the efficacy in LANPC requires further investigation...Conclusions Envafolimab plus chemoradiotherapy showed encouraging efficacy and safty in the treatment of LANPC. The 3-year PFS data were immature, and further follow-up will be warranted."

Clinical • Metastases • P2 data • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Envafolimab and radiochemotherapy for locally advanced cervical cancer: A prospective, single-arm, phase II study (ESMO 2025) - P2 | "The CCRT regimen included 5 cycles (with optional 6th dose) of cisplatin 40 mg/m2 Q1W + EBRT then brachytherapy.The primary endpoint was the 2-year PFS rate...Conclusions This is the first study to demonstrate that envafolimab + CCRT have preliminary efficacy and a tolerable safety profile in patients with locally advanced cervical cancer. This study is still in progress and further analyses are undergoing to determine longer-term outcomes."

Clinical • Metastases • P2 data • Cervical Cancer • Cervical Squamous Cell Carcinoma • Oncology • Solid Tumor • Squamous Cell Carcinoma

Envafolimab combined with recombinant human endostatin and chemotherapy as first-line treatment in metastatic pancreatic cancer: A single-arm, exploratory, phase II trial (ESMO 2025) - "Despite current first-line therapies like AG (gemcitabine plus nab-paclitaxel) and FOLFIRINOX, the 5-year survival rate remains below 5%...Conclusions This preliminary data suggests that the combination of Envafolimab, Rh-endostatin, and AG as first-line therapy for mPC demonstrates promising efficacy with acceptable tolerability. Legal entity responsible for the study The authors."

Clinical • Metastases • P2 data • Oncology • Pancreatic Cancer • Solid Tumor

Efficacy and safety of first-line etoposide plus anlotinib and envafolimab in elderly patients with small-cell lung cancer: an open-label, single-arm, phase II study [WITHDRAWN] (ESMO 2025) - No abstract available

Clinical • P2 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Neoadjuvant envafolimab combined with chemoradiotherapy in locally advanced rectal cancer: An exploratory, phase II study (ESMO 2025) - "Eligible pts received short-course radiotherapy (25 Gy/5f) with subsequent 4 cycles of envafolimab (300mg) plus CapeOX (oxaliplatin: 130mg/m 2; capecitabine: 1000mg/m 2 ), followed by surgical resection...More data will be updated from this ongoing study. Legal entity responsible for the study The authors."

Clinical • IO biomarker • Metastases • P2 data • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor • PD-L1

BREAKING RESISTANCE AND REWRITING THE SYSTEMIC PLAYBOOK: A SCOPING REVIEW OF COMBINATION TARGETED THERAPIES IN ADVANCED HEPATOCELLULAR CARCINOMA (AASLD 2025) - "This scoping review addresses the latest combination regimens with drugs such as sorafenib, lenvatinib, cabozantinib, regorafenib, and ramucirumab concerning their clinical impact and immunologic rationale...Lenvatinib plus envafolimab and cabozantinib plus atezolizumab as front-line treatments demonstrated increased PFS and disease control, but with inconsistent OS benefit, compared to monotherapies... This review illustrates an important shift in research towards combined immunotherapeutic HCC therapies that aim to avoid resistance and extend patient eligibility. The preliminary results from the observed clinical trials suggest moving towards these regimens, guided by known drivers and immune signatures. Future directions should focus on biomarker-based tumor selection, dose optimization, and combination with locoregional or cell-based modalities to offer a clear roadmap to enhance systemic impact."

IO biomarker • Metastases • Review • Fibrosis • Hepatocellular Cancer • Immunology • Liver Cancer • Oncology • Solid Tumor • KDR

Efficacy, safety, and exploratory biomarker analysis of envafolimab plus carboplatin and etoposide as first-line treatment for extensive-stage small-cell lung cancer: a prospective, single-arm, phase II trial. (PubMed, BMC Med) - P2 | "Envafolimab combined with chemotherapy as a first-line treatment for ES-SCLC yielded favorable clinical efficacy with a manageable safety profile, indicating that it may be a promising treatment modality."

Biomarker • Journal • P2 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CCL3 • CXCL10 • CXCL8

Neoadjuvant envafolimab combined with SOX chemotherapy in patients(Including elderly and bleeding) with locally advanced gastric cancer: A prospective, single-arm, phase II trial(FRIENDSHIP-GC-01 trial) (KINGCA Week 2025) - "All of the patients received neoadjuvant therapy (Envafolimab 300 mg Q3W + SOX (S-1 40mg, Oxaliplatin 130 mg/m2)Q3W )for 3 cycle, followed by surgery, adjuvant therapy (Envafolimab 300 mg Q3W + SOX (S-1 40mg, Oxaliplatin 130 mg/m2)Q3W)for 3-5 cycle...The preliminary research results are gratifying. CONCLUSIONS : Mid term data shows the efficacy and safety of neoadjuvant and adjuvant envafolimab combined with SOX chemotherapy in patients with locally advanced gastric cancer is worth looking forward to."

Clinical • Metastases • P2 data • Gastric Adenocarcinoma • Gastric Cancer • Gastroenterology • Oncology • Solid Tumor