The 2026 Congress of the European Society for Medical Oncology (ESMO) is being held in Madrid, Spain, from October 23 to 27. As one of the international oncology bellwethers alongside ASCO and WCLC, the studies selected for ESMO represent the most valuable clinical advances of the year.Envafolimab (injection), the world's first approved subcutaneous PD-L1 inhibitor and a commercialized product of 3D Medicines (1244.HK), has six studies featured at this year's congress: one Rapid Oral presentation, four posters and one e-Poster. The studies span biliary tract cancer, MSI-H/dMMR advanced solid tumors, extensive-stage small cell lung cancer, soft tissue sarcoma, locally advanced colon cancer and gallbladder cancer — a China-developed regimen that completes administration in 30 seconds and continues to push the boundaries of subcutaneous immunotherapy.

Among them, the registrational Phase III study ofEnvafolimab plus GEMOX as first-line treatment for advanced biliary tract cancer was selected for a Rapid Oral presentation. The marketing application based on this study was accepted by China's National Medical Products Administration (NMPA) in January 2026, and is expected to offer a new first-line subcutaneous immuno-combination option for patients with advanced biliary tract cancer.

Envafolimab

Six Studies Extend the Boundaries of Subcutaneous Immunotherapy

01  Biliary Tract Cancer, Registrational Phase III

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

Presentation: Rapid Oral  |  Abstract No.: 473RO  |  Investigator: Qin Shukui (Nanjing Tianyinshan Hospital)

Results: 462 patients were included in the efficacy analysis; mOS was 10.9 vs 8.6 months (HR 0.723), with 3-year OS rates of 12.5% vs 7.7%; mPFS was 5.4 vs 4.5 months; ORR was 27.6% vs 20.9%; the 12-month DOR rate was 33.6% vs 9.6%.

02  MSI-H/dMMR Advanced Solid Tumors, Registrational Phase II

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)

Presentation: Poster  |  Abstract No.: 1972P  |  Investigator: Shen Lin (Peking University Cancer Hospital)

Results: This study reports the longest follow-up (median 74.4 months) and the most mature long-term survival data in the pan-tumor MSI-H/dMMR population. In the overall population, ORR was 48.1% (95% CI: 40.7%–55.6%); mPFS was 31.3 months (95% CI: 16.5–NE) and mOS was 78.3 months (95% CI: 47.6–NE).

03  Extensive-Stage Small Cell Lung Cancer

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

Presentation: Poster  |  Abstract No.: 3828P  |  Investigator: Zhang Jian (Zhujiang Hospital of Southern Medical University)

Results: Among 32 evaluable patients, ORR was 78.1% and DCR 96.9%; median PFS was 6.3 months with a 6-month PFS rate of 58.5%, and median OS was 17.9 months. Grade ≥3 TRAEs occurred in 33.3% of patients, with no grade 5 TRAEs reported.

04  Soft Tissue Sarcoma

Phase II Study of First-line Envafolimab in Combination with Liposomal Doxorubicin and Ifosfamide for Advanced Soft Tissue Sarcoma

Presentation: Poster  |  Abstract No.: 3746P  |  Investigator: Dong Ying (Second Affiliated Hospital, Zhejiang University School of Medicine)

Results: 24 patients were enrolled: median PFS was 10.4 months and median OS was not reached; ORR was 38.1% and DCR 85.7%; grade 3–4 TRAEs occurred in 33.3%, with no unexpected immune-related safety signals observed.

05  Neoadjuvant Treatment, Locally Advanced Colon Cancer

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)

Presentation: Poster  |  Abstract No.: 839P  |  Investigator: Lu Zhenhai (Sun Yat-sen University Cancer Center)

Results: 67 patients were enrolled; in the dMMR/MSI-H cohort, pCR was 48.0% and overall CR 52.0%; in the MSS/pMMR cohort, pCR was 23.8%; R0 resection was achieved in 100% of operated patients in both cohorts.

06  Gallbladder Cancer in Elderly Patients

First-Line Envafolimab, Lenvatinib, and Capecitabine for Elderly Patients With Unresectable or Metastatic Gallbladder Cancer: A Single-Arm Exploratory Study

Presentation: e-Poster  |  Abstract No.: 499eP  |  Investigator: Huang Fan (First Affiliated Hospital of Anhui Medical University)

Results: 26 patients were enrolled: median PFS was 7.3 months and OS 8.3 months, with a 2-year OS rate of 19.4%; ORR was 40% and DCR 90%; 5 patients achieved conversion to R0 resection (including 1 pCR).

AboutEnvafolimab (Envafolimab Injection)

ENWEIDA® (envafolimab injection) was independently developed by Alphamab Oncology and has been co-developed with 3D Medicines since 2016. On March 30, 2020, Alphamab Oncology, 3D Medicines and Simcere Pharmaceutical entered into a strategic collaboration under which Alphamab Oncology, as the originator, is responsible for manufacturing and quality; 3D Medicines is responsible for clinical development in oncology; and Simcere Pharmaceutical holds the exclusive right to commercialize the product in mainland China. Owing to its unique design,Envafolimab offers advantages in efficacy, safety, convenience and compliance: patients do not require intravenous infusion, and the product is expected to reduce healthcare costs. Clinical trials in multiple tumor indications are currently underway in China, the United States and Japan, with several indications in registrational/Phase III development. Envafolimab has been granted Orphan Drug Designation by the U.S. FDA for advanced biliary tract cancer, soft tissue sarcoma, and gastric and gastroesophageal junction cancer.

In November 2021,Envafolimab was approved in China, the first product of its kind to be launched in the country, for the treatment of adult patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) advanced solid tumors, including patients with advanced colorectal cancer who have progressed after treatment with fluoropyrimidines, oxaliplatin and irinotecan, and patients with other advanced solid tumors who have progressed after prior treatment and for whom no satisfactory alternative treatment options exist.

About 3D Medicines Inc.

3D Medicines (1244.HK) is a commercial-stage oncology company dedicated to the discovery and development of innovative, differentiated drug and vaccine candidates with global first-in-class or clinical value. The company has built an international team spanning R&D, manufacturing and commercialization, and is committed to helping cancer patients live longer and better. Of its 17 pipeline programs, 8 have entered clinical development. Its first commercialized product,Envafolimab — the world's first subcutaneous PD-L1 single-domain antibody — has reached tens of thousands of patients in the five years since launch, establishing a differentiated position in tumor immunotherapy.

The company's innovation is driven by three proprietary platforms. Its innovative in vivo CAR-T/NK platform generates autologous CAR-T cells in vivo across oncology and autoimmune indications; through a proprietary tLNP delivery system, it overcomes the limitations of conventional ex vivo CAR-T therapies by eliminating the need for lymphodepletion, enabling safer and more accessible off-the-shelf immunotherapies. The AI + mRNA tumor vaccine platform, 3D-preciseAG, builds on an in-house LNP delivery system to break through patent barriers, significantly improving mRNA delivery efficiency while reducing toxicity. The radioligand drug conjugate (RDC) platform focuses on developing radiopharmaceuticals with best-in-class potential. Putting patient benefit at the center, 3D Medicines pursues a dual strategy of scientific innovation and efficient commercialization to continuously enhance the global competitiveness of its products, create long-term value for shareholders and drive sustainable growth.

For more information, please visit: http://www.3d-medicines.com

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