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

First-Line Envafolimab, Lenvatinib, and Capecitabine for Elderly Patients With Unresectable or Metastatic Gallbladder Cancer: A Single-Arm Exploratory Study (ESMO 2026) - No abstract available

Clinical • Metastases • Gallbladder Cancer • Oncology • Solid Tumor

Envafolimab Plus Nab-Paclitaxel and Platinum as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer (ES-SCLC): An Open-Label, Single-Arm, Phase II Trial (ESMO 2026) - No abstract available

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

Phase II Study of First-line Envafolimab in Combination with Liposomal Doxorubicin and Ifosfamide for Advanced Soft Tissue Sarcoma (ESMO 2026) - No abstract available

Clinical • Combination therapy • Metastases • P2 data • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Efficacy and Safety of Envafolimab, a novel subcutaneous anti-PD-L1 inhibitor, in patients with advanced MSI-H/dMMR solid tumors: final results from the pivotal Phase II study(KN035-CN-006) (ESMO 2026) - No abstract available

Clinical • dMMR • Metastases • MSI-H • P2 data • Microsatellite Instability • Oncology • Solid Tumor • MSI

Envafolimab (anti-PD-L1) as Monotherapy or in Combination with CAPEOX for Neoadjuvant Treatment of Locally Advanced Colon Cancer (ESMO 2026) - No abstract available

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

Subcutaneous anti-PD-L1 monoclonal antibody Envafolimab plus gemcitabine and oxaliplatin (GEMOX) versus GEMOX alone as first-line treatment for advanced biliary tract cancer in Chinese patients: A randomized, open-label, multicenter, registrational phase III trial (ESMO 2026) - No abstract available

Clinical • Metastases • P3 data • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

Envafolimab combined with lenvatinib and gemcitabine plus cisplatin in advanced biliary tract cancer as first-line treatment: A multicenter, single-arm, open-label, phase II study (ENLIGHTEN study). (ASCO 2026) - P2 | "In summary, our study demonstrates that the quadruplet regimen of envafolimab, lenvatinib, gemcitabine, and cisplatin demonstrates promising efficacy and well-tolerated first-line therapy for advanced BTC."

Clinical • Metastases • P2 data • Biliary Cancer • Biliary Tract Cancer • Neutropenia • Oncology • Solid Tumor

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

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 | Initiation date: Dec 2025 ➔ Dec 2026

Trial initiation date • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

PRECAM-R: Preoperative Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Rectal Adenocarcinoma (clinicaltrials.gov) - P3 | N=108 | Recruiting | Sponsor: Sir Run Run Shaw Hospital | Trial primary completion date: Apr 2025 ➔ Nov 2026

Trial primary completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Rectal Adenocarcinoma • Rectal Cancer • Solid Tumor

KN035-BTC: Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC (clinicaltrials.gov) - P3 | N=472 | Completed | Sponsor: 3D Medicines (Sichuan) Co., Ltd. | Active, not recruiting ➔ Completed

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

Endouble 2: SRT Combined With Envafolimab and Endostar in the First-line Treatment of Advanced NSCLC (clinicaltrials.gov) - P2 | N=61 | Not yet recruiting | Sponsor: The First People's Hospital of Lianyungang

IO biomarker • New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1 • ROS1

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

Triplet Therapy Improves Outcomes in SMARCA4-Mutant Lung Cancer: Integrated Clinical Evidence and Spatial Transcriptomic Insights (IASLC-WCLC 2026) - "This benefit may arise from targeting aberrant angiogenesis and reshaping the tumor immune microenvironment. These findings support triplet therapy as a promising therapeutic strategy and provide a biologically grounded rationale for its use in this high-risk population."

Clinical • IO biomarker • Lung Cancer • Oncology • Solid Tumor • CD8 • SMARCA4

Envafolimab (KN035) plus gemcitabine and oxaliplatin (GEMOX) compared with GEMOX as first-line treatment for Chinese patients with advanced biliary tract cancer: A randomized, open-label, multi-center, phase III pivotal trial. (ASCO 2026) - P3 | "This study demonstrates that adding subcutaneously administered envafolimab to GEMOX significantly improves OS with a manageable safety profile in advanced BTC. Compared with other regimens, the combination showed robust efficacy with a low rate of irAEs. Those findings establish envafolimab, the world's first SC PD-L1 inhibitor, combined with GEMOX as a new, effective, and convenient standard of care for this population."

Clinical • Metastases • P3 data • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Oncology • 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

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 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

Dynamic Granulocyte Turnover Inferred From cfDNA Methylation Predicts Immunotherapy Benefit in Liver-Metastatic Small-Cell Lung Cancer (IASLC-WCLC 2026) - "Methods : Patients with ES-SCLC and liver metastases received first-line envafolimab combined with platinum-etoposide chemotherapy for four cycles, followed by maintenance envafolimab until disease progression or intolerable toxicity...Integrated multi-omics analysis identified cfDNA methylation-inferred granulocyte turnover as a clinically relevant biomarker associated with liver tumor dynamics, immune dysfunction, and survival. These findings support the potential utility of granulocyte turnover for real-time monitoring and risk stratification and highlight the value of combining cfDNA methylation profiling with other omics approaches to improve precision immunotherapy in SCLC with liver metastases."

cfDNA • IO biomarker • Metastases • Hepatology • Liver Cancer • Liver Failure • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • NCAM1 • TNFRSF9 • ZFHX4

Envafolimab - novel anti-PD-1/PD-L1 antibody in cancer treatment. (PubMed, Front Immunol) - "PD-1/PD-L1 blockade agents, such as FDA-approved nivolumab, pembrolizumab, and dostarlimab, have demonstrated significant clinical efficacy across various malignancies...Tailoring treatments based on individual genetic, immunological, and microbiome profiles holds the potential to enhance response rates and the durability of outcomes. The integration of these factors is pivotal in advancing the precision and success of immunotherapy in oncology."

Journal • Review • Oncology • Solid Tumor

Dynamic Granulocyte Turnover Inferred From cfDNA Methylation Predicts Immunotherapy Benefit in Liver-Metastatic Small Cell Lung Cancer: A Prospective Biomarker Study. (PubMed, MedComm (2020)) - "cfDNA-based assessment of granulocyte turnover reflected both liver damage and tumor dynamics, suggesting its potential for real-time monitoring. These findings suggest that granulocyte activity may contribute to an immunosuppressive tumor microenvironment and serve as a predictive marker for treatment stratification in SCLC with LM."

Biomarker • IO biomarker • Journal • Hepatology • Liver Failure • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • TNFRSF9

Postoperative cutaneous metastasis of breast cancer with phenotypic conversion to triple-negative subtype: A case report. (PubMed, Medicine (Baltimore)) - "This case underlines re-biopsy importance. Conversion to a triple-negative phenotype necessitates complete change in systemic therapy. Phenotypic conversion may first manifest in lymph node metastases before becoming clinically evident in cutaneous lesions."

Journal • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Neutropenia • Oncology • Skin Cancer • Solid Tumor • Triple Negative Breast Cancer • HER-2

Inhibited proliferation and immune evasion of lung cancer: The key role of miR-4483 in lncRNA linc00824/miR-4483/PD-L1 pathway. (PubMed, Biochem Biophys Res Commun) - "In summary, lactate-induced histone lactylation drives linc00824 upregulation, facilitating lung cancer progression by enhancing tumor cell proliferation and suppressing T cell antitumor function via regulating miR-4483/PD-L1. We identified an antitumor strategy for lung cancer by using miR-4483."

IO biomarker • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8

HCC: Study on the Combined Treatment of Hepatocellular Carcinoma With Envafolimab, Suvemcitug and HAIC Conversion (clinicaltrials.gov) - P=N/A | N=35 | Not yet recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

New trial • Hepatocellular Cancer • Oncology • Solid Tumor

ICE Study: Combination of Irinotecan Plus Cetuximab and Envafolimab as a Rechallenge Regimen in mCRC (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Beijing Hospital | Trial completion date: Aug 2026 ➔ Dec 2026 | Trial primary completion date: Feb 2026 ➔ Dec 2026

Trial completion date • Trial primary completion date • Colorectal Cancer • Oncology • Solid Tumor • BRAF • KRAS • RAS