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

Efficacy and Safety of Envafolimab Combined With Capecitabine and Lenvatinib as Postoperative Adjuvant Therapy in Resected Biliary Tract Cancer With High-Risk Recurrence Factors: A Phase II Single-Center Prospective Study. (PubMed, Cancer Med) - "The adjuvant combination of envafolimab, lenvatinib, and capecitabine demonstrates promising efficacy and a manageable safety profile in high-risk BTC patients after R0 resection. However, these findings still require validation in larger, multicenter, randomized controlled trials."

Journal • P2 data • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor • CA 19-9

Study of Envafolimab Alone or With Lenvatinib in Patients With Advanced Endometrial Cancer (clinicaltrials.gov) - P2 | N=108 | Recruiting | Sponsor: 3D Medicines (Sichuan) Co., Ltd. | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Endometrial Cancer • Oncology • Solid Tumor

KN035-CN-017: Phase III Study of Envafolimab Versus Placebo Plus Chemotherapy in Resectable Stage III NSCLC (clinicaltrials.gov) - P3 | N=390 | Recruiting | Sponsor: 3D Medicines (Sichuan) Co., Ltd. | Trial completion date: Sep 2027 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2027

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

KN035 for dMMR/MSI-H Advanced Solid Tumors (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: 3D Medicines (Sichuan) Co., Ltd. | Trial primary completion date: Dec 2025 ➔ Dec 2026

dMMR • Monotherapy • MSI-H • Trial primary completion date • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

Multicenter Phase 2 Study of Envafolimab in Biliary Tract Cancers (clinicaltrials.gov) - P2 | N=126 | Not yet recruiting | Sponsor: 3D Medicines (Sichuan) Co., Ltd. | Trial completion date: Jun 2027 ➔ Dec 2029 | Trial primary completion date: Jun 2026 ➔ Jun 2029

Trial completion date • Trial primary completion date • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Oncology • Solid Tumor

Phase Ib/II Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors (clinicaltrials.gov) - P1/2 | N=170 | Recruiting | Sponsor: 3D Medicines (Sichuan) Co., Ltd. | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial primary completion date • Genito-urinary Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Thyroid Gland Carcinoma

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

TACE plus Lenvatinib and Envafolimab for Conversion Therapy in Unresectable HCC: A Prospective, Phase II Study (APASL 2026) - No abstract available

Clinical • P2 data • Hepatocellular Cancer

Triplet Therapy with Envafolimab, Lenvatinib, and TACE Enables Curative Conversion and Pathological Response in Unresectable HCC: A Single-Arm Phase II study (APASL 2026) - No abstract available

Clinical • P2 data • Hepatocellular Cancer

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) - P2 | "The reduction in pro-inflammatory cytokines may support its immune-modulatory role. Ongoing follow-up will confirm long-term OS benefits."

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

Seasons of risk: Investigating temporal trends in ICI-associated Myocarditis (AACR-IO 2026) - "Pembrolizumab was the predominant regimen (54%), followed by ipilimumab + nivolumab (25%), cemiplimab (8%), nivolumab (6%), durvalumab (4%), and envafolimab (2%)...In: Proceedings of the AACR Immuno-Oncology Conference (AACR IO): Discovery and Innovation in Cancer Immunology: Revolutionizing Treatment through Immunotherapy; 2026 Feb 18-21; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Immunol Res 2026;14(2 Suppl):Abstract nr B069."

Cardiovascular • Infectious Disease • Inflammation • Melanoma • Solid Tumor

A Preclinical Study of [64Cu]Cu-NOTA-KN035 for Molecular Imaging of PD-L1 in Tumors. (PubMed, Mol Pharm) - "Tumor uptake decreased significantly after blocking with excess KN035, confirming the specificity. These results demonstrate the high PD-L1-targeting specificity of [64Cu]Cu-NOTA-KN035, suggesting its great potential as a noninvasive diagnostic tool for immunotherapy-based treatments in the future."

IO biomarker • Journal • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-1 • PD-L1

Envafolimab Combined With Chemoradiotherapy and Recombinant Human Endostatin for LA-NPC. (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Chongqing University Cancer Hospital | N=45 ➔ 30 | Trial completion date: Oct 2027 ➔ Feb 2027 | Trial primary completion date: Oct 2027 ➔ Feb 2027

Enrollment change • Trial completion date • Trial primary completion date • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor • PD-L1

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

Envafolimab-Associated Toxic Epidermal Necrolysis. (PubMed, Am J Ther) - No abstract available

Journal • Steven-Johnson Syndrome

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

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