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

Toxic epidermal necrolysis associated with immune checkpoint inhibitors for bladder cancer: A case report. (PubMed, Zhong Nan Da Xue Xue Bao Yi Xue Ban) - "In May 2024, he developed immune-related myocarditis after treatment with toripalimab...TEN is a rare but serious irAE in ICIs treatment. Suspected patients should be intervened early, and patients who have already developed it should be actively treated, in order to enhance the understanding and management of TEN caused by ICIs treatment."

Checkpoint inhibition • Journal • Bladder Cancer • Cardiovascular • Genito-urinary Cancer • Oncology • Solid Tumor • Steven-Johnson Syndrome

Interim Results of a Randomized Phase II Trial of Trilaciclib Combined with Envafolimab, Etoposide, and Carboplatin as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer (ELCC 2026) - No abstract available

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

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 | Trial completion date: Dec 2025 ➔ May 2026

Trial completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Dually Nanobody-Engineered Milk-Derived Extracellular Vesicle Nanomedicine Targeting Tumour-Associated Macrophages and Cancer Cells for Cancer Therapy. (PubMed, J Extracell Vesicles) - "In this study, we developed a dual-targeted engineered milk-derived extracellular vesicles system (7D12/KN035-iEVs), decorated with 7D12 (an EGFR nanobody) and KN035 (a PD-L1 nanobody), to specifically deliver miR-21-5p inhibitors into EGFR+ and/or PD-L1+ tumour cells and TAMs, thereby inhibiting tumour progression while reprogramming immunosuppressive TME. Notably, this dual-targeting nanomedicine synergistically inhibits tumour growth when combined with immunotherapy and radiotherapy. In summary, this mEV-based nanomedicine represents a promising universal strategy for cancer treatment, offering a versatile platform for targeting multiple components of the TME."

Journal • Oncology • EGFR • MIR21

Case Report: Multimodal immunotherapeutic regimen (envafolimab + chemotherapy + radiotherapy) for four synchronous primary malignant neoplasms: a case report of 33-month survival and implications for tumor immunology. (PubMed, Front Oncol) - "Using this case as a foundation, we discuss recent advances in immunotherapy for MPMNs, covering its mechanisms of action, clinical efficacy, therapeutic strategies, and current challenges. The goal is to provide a theoretical basis for clinical practice and identify future research directions."

Journal • Oncology • Solid Tumor

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

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

Efficacy and safety of combining short-course neoadjuvant chemoradiotherapy with envafolimab in locally advanced rectal cancer patients with microsatellite stability: A phase II PRECAM experimental study. (PubMed, Int J Surg) - "In LARC patients exhibiting MSS tumors, combining short-course nCRT with Envafolimab demonstrated favorable efficacy, leading to a significant pCR rate. Minor adverse effects and surgical complications were observed. These preliminary but promising results underscore the potential of this approach and call for further exploration and validation through a randomized controlled trial."

Journal • Metastases • P2 data • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Infectious Disease • Oncology • Rectal Cancer • Solid Tumor

JSKN033, an innovative subcutaneous-injected fixed-dose combination (FDC) of biparatopic anti-HER2 antibody drug conjugate (ADC) and PD-L1 inhibitor in advanced solid tumor (SITC 2024) - P1/2 | "Subcutaneous (SC) delivery offers a safer alternative, with comparable efficacy to intravenous delivery, as demonstrated by treatments like amivantamab. JSKN033 is a FDC for SC injection, utilizing innovative technology, comprising JSKN003, a biparatopic HER2-directed ADC, and KN035, a NMPA-approved PD-L1 inhibitor...These results encourage further clinical development of JSKN033. Additionally, the formulation technology may be applicable to other ADC therapies.View this table:View inline View popup Download powerpoint Abstract 1496 Table 1"

IO biomarker • Late-breaking abstract • Metastases • Biliary Cancer • Biliary Tract Cancer • Breast Cancer • Colorectal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Salivary Gland Cancer • Solid Tumor

PD-L1 Blockade with Biodegradable Envafolimab-Loaded Microspheres Synergizes with Transarterial Chemoembolization to Overcome Myeloid-Derived Suppressor Cell-Driven Immune Escape in Hepatocellular Carcinoma. (PubMed, ACS Appl Mater Interfaces) - "These findings establish KN035-MS as a synergistic adjunct to TACE, addressing both inefficient drug delivery and postembolization immune evasion. This dual-mechanism strategy provides a clinically translatable approach to mitigate HCC recurrence, warranting further investigation in combinatorial locoregional-immunotherapy paradigms."

Journal • Hepatocellular Cancer • Oncology • Solid Tumor • CD4 • CD8

Progression-free survival with the ICE regimen in refractory RAS/BRAF wild-type and MSS mCRC patients. (ASCO-GI 2026) - P2 | "This study investigates the clinical efficacy and safety of ICE regimen (Irinotecan Plus Cetuximab and Envafolimab... The ICE regimen demonstrates promising antitumor activity and manageable toxicity in heavily pretreated RAS/BRAF WT, MSS mCRC patients. A prospective, multicenter, open-label phase II trial (NCT06321081) investigating ICE as a rechallenge strategy is currently underway. Due to the favorable outcomes observed, we have initiated development of the "ICE2" protocol and are applying for its use as a first-line treatment in elderly patients with RAS/BRAF WT/MSS mCRC."

Clinical • IO biomarker • Colorectal Cancer • Gastrointestinal Cancer • BRAF • EGFR • FBXW7 • PD-L1 • RAS

Alphamab Oncology’s KN035 NDA for First-Line Biliary Tract Cancer Accepted by China’s NMPA (TipRanks) - "Alphamab Oncology announced that China’s National Medical Products Administration has accepted its new drug application for KN035 (Envafolimab, ENWEIDA) in combination with GEMOX chemotherapy as a first-line treatment for unresectable or metastatic biliary tract cancer, based on data from a phase III trial in Chinese patients comparing the combo against GEMOX alone."

China filing • Biliary Tract Cancer

Successful treatment of lung squamous cell carcinoma with envafolimab, a PD-L1 inhibitor combined with chemotherapy: a case report. (PubMed, Transl Cancer Res) - "Initial immunohistochemistry revealed a tumor proportion score for PD-L1 ≥1%, prompting the following standard first-line therapy as per the guidelines: three cycles of albumin-bound paclitaxel [470 mg, day (d)1], carboplatin (568 mg, d1), and pembrolizumab (200 mg, d1)...Subsequently, second-line therapy comprising two cycles of gemcitabine (1.6 g, d1; 1.4 g, d8), cisplatin (40 mg, d1-3), endostar (30 mg, d1-4), and subcutaneous envafolimab (200 mg, d1) was initiated...It suggests that envafolimab warrants consideration as a viable treatment option in this setting, particularly following the failure of PD-1 inhibitors. Further larger clinical trials need to be conducted to confirm these findings and define its optimal role in the NSCLC treatment sequence."

Journal • Hepatocellular Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma

Cetuximab β Combined With PRaG Regimen in the Treatment of EGFR-positive Advanced Refractory Solid Tumors (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Second Affiliated Hospital of Soochow University

New P2 trial • Colorectal Cancer • Solid Tumor • BRAF • EGFR • RAS

Long-term survival of an advanced gastric cancer patient with multiple liver metastases following maintenance therapy with envafolimab and oral chemotherapy: a case report. (PubMed, Front Oncol) - "The patient had 46 months of overall survival time with a good performance status. This case recommends that maintenance therapy comprising of both PD-L1 blockage and oral fluoropyrimidine can serve as long-duration disease control and significant long-term advantage to a subset of the patients with metastatic immune-cold gastric cancer."

IO biomarker • Journal • Tumor mutational burden • Gastric Adenocarcinoma • Gastric Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • HER-2 • TMB

CEIL: Cetuximab and Envafolimab Plus mFOLFOXIRI as First-line Treatment for RAS/BRAF Wild-type, MSS, Unresectable Left-side Metastatic Colorectal Cancer (clinicaltrials.gov) - P2 | N=198 | Recruiting | Sponsor: Sun Yat-sen University | Trial completion date: Dec 2027 ➔ Dec 2028 | Trial primary completion date: Mar 2026 ➔ Dec 2026

Trial completion date • Trial primary completion date • Colorectal Cancer • Oncology • Solid Tumor • BRAF • EGFR

3D Medicines has received orphan-drug designation for its PD-L1 inhibitor Envafolimab (KN035) for the treatment of gastric cancer and gastro-esophageal junction cancer, marking the third such designation for the product…. (TipRanks) - "The new status is supported by Phase II data in advanced gastric/gastro-esophageal junction adenocarcinoma, where Envafolimab combined with FOLFOX achieved a 60% objective response rate and 100% disease control with favorable safety..."

Orphan drug • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

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