Puyouheng (pucotenlimab) / Taizhou Hanzhong Biopharma, Lepu Biopharma, HanX Biopharma, Akesobio - LARVOL DELTA

Four clinical studies selected for presentation at 2026 ESMO congress: CMG901 (AZD0901) clinical trial results selected as LBA for proffered paper presentation at presidential symposium, MRG007 clinical trial results selected as LBA for rapid oral presentation, and two other studies selected for rapid oral presentation (HKEXnews) - "(1) the Phase III clinical trial of CMG901 in second or later-line (2L+) advanced/metastatic Claudin 18.2-positive gastroesophageal carcinoma ('GEC') has been accepted for presentation as a late-breaking abstract ('LBA') for Proffered Paper presentation at the Presidential Symposium; (2) the Phase I clinical study of MRG007...for the treatment of colorectal cancer ('CRC') has been selected as an LBA for rapid oral presentation; (3) the Phase II study in Europe for the combination therapy of MRG003 and HX008 targeting locally advanced head and neck squamous cell carcinoma ('LA-HNSCC') has been selected for rapid oral presentation; and (4) the Phase II study for the combination therapy of MRG003 and HX008 in epidermal growth factor receptor-positive ('EGFR-positive') unresectable anaplastic/poorly differentiated thyroid cancer has been selected for rapid oral presentation, at the 2026 European Society for Medical Oncology (the 'ESMO') Congress."

Late-breaking abstract • P1 data • P2 data • P3 data • Colorectal Cancer • Gastroesophageal Cancer • Squamous Cell Carcinoma of Head and Neck • Thyroid Gland Carcinoma

A Phase II, Prospective, Single-arm, Exploratory Study of Becotatug vedotin plus pucotenlimab as Neoadjuvant Therapy for Patients with Resectable, Locally Advanced, EGFR-Positive Esophageal Squamous Cell Carcinoma (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma • EGFR

Becotatug vedotin in combination with pucotenlimab and bevacizumab is being investigated in EGFR‑positive recurrent glioblastoma : a single‑arm, single‑center, exploratory phase II trial (ESMO 2026) - No abstract available

Clinical • Combination therapy • P2 data • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • EGFR

Becotatug vedotin plus pucotenlimab as second-line therapy in patients with advanced biliary tract cancer: A phase II exploratory study. (ESMO 2026) - No abstract available

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

First Interim Safety analysis of GORTEC 2024-03 IDEAL: randomized phase II trial of induction treatment anti–PD-1 pucotenlimab (HX008) plus EGFR-ADC (becotatug vedotin (MRG003) versus EGFR-ADC alone followed by chemoradiotherapy in locally advanced head and neck squamous cell carcinoma (ESMO 2026) - No abstract available

ADC • Clinical • Metastases • P2 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR

The efficacy and safety of becotatug vedotin and pucotenlimab in EGFR-positive unresectable anaplastic/ poorly differentiated thyroid cancer: preliminary results from a phase II clinical trial (ESMO 2026) - No abstract available

Clinical • P2 data • Oncology • Solid Tumor • Thyroid Gland Carcinoma • EGFR

A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck (clinicaltrials.gov) - P2 | N=70 | Completed | Sponsor: Lepu Biopharma Co., Ltd. | Recruiting ➔ Completed | N=116 ➔ 70

Enrollment change • Trial completion • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

MH-Penile-002: a phase II, prospective, single-arm trial of neoadjuvant anti-EGFR antibody-drug conjugate plus PD-1 inhibitor in penile cancer with challenging penile preservation or regional lymph node metastasis. (PubMed, Future Oncol) - P2 | "This single-center, prospective, single-arm, phase II trial evaluates the efficacy and safety of neoadjuvant Becotatug Vedotin plus Pucotenlimab in EGFR-expressing PSCC patients with challenging penile preservation or regional lymph node metastasis. The study plans to enroll 60 patients with EGFR-expressing PSCC. Clinical trial registration: www.clinicaltrials.gov identifier is NCT07518979."

Journal • P2 data • Genito-urinary Cancer • Oncology • Penile Cancer • Solid Tumor • Squamous Cell Carcinoma • EGFR

Efficacy and Safety of Vibepolimab Combined with Platinum and Pufelimab Induction Therapy Followed by Concurrent Radiotherapy Plus Vibepolimab in Patients with Advanced Cervical Cancer: A Prospective, Single-Center, Single-Arm Phase II Clinical Study (ChiCTR) - P2 | N=26 | Not yet recruiting | Sponsor: Huizhou Central People's Hospital; Huizhou Central People's Hospital

New P2 trial • Cervical Cancer • Oncology • Solid Tumor • EGFR

A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Fudan University | Not yet recruiting ➔ Recruiting | Initiation date: May 2026 ➔ Sep 2026

Enrollment open • IO biomarker • Trial initiation date • Genito-urinary Cancer • Oncology • Penile Cancer • Solid Tumor • EGFR

Updated long term efficacy results of phase II study for becotatug vedotin combined with pucotenlimab in recurrent or metastatic nasopharyngeal carcinoma (R/M-NPC) (ESMO 2025) - "It may provide an efficacious treatment option for R/M-NPC pts who had failed anti-PD-(L)1 and platinum-based therapy. The efficacy and safety of MRG003 combined with HX008 in NPC is currently undergoing further investigation in randomized controlled clinical trials."

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

A prospective, single-arm, multicenter exploration of the treatment of EGFR-positive, unresectable, recurrent or metastatic squamous cell carcinoma of the urogenital system (urethra, penis, kidney, ureter, bladder, etc.) with at least one line of systemic chemotherapy using durvalumab (EGFR-ADC) in combination with pembrolizumab (PD-1) (ChiCTR) - P=N/A | N=28 | Not yet recruiting | Sponsor: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital

New trial • Oncology • Squamous Cell Carcinoma • Urology • EGFR

Becotatug Vedotin Plus Pucotenlimab and Capecitabine Followed by Concurrent Chemoradiotherapy-Immunotherapy for Locally Advanced Squamous Cell Carcinoma of the Anal Canal (clinicaltrials.gov) - P2 | N=34 | Not yet recruiting | Sponsor: Wang Xin

New P2 trial • Anal Carcinoma • Oncology • Squamous Cell Carcinoma • EGFR

Becotatug Vedotin Plus Pucotenlimab and Platinum Chemotherapy in Locally Advanced Epidermal Growth Factor Receptor (EGFR)-Positive Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Xuekui Liu

New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR

MRG003-C001: A Study of MRG003 in the Treatment of Patients With EGFR-positive Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=18 | Recruiting | Sponsor: Lepu Biopharma Co., Ltd. | Trial completion date: Jul 2025 ➔ Aug 2027 | Trial primary completion date: May 2025 ➔ Aug 2027

Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • EGFR

Becotatug Vedotin Combined With Pucotenlimab in Platinum- and Immunotherapy-Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma. (PubMed, J Clin Oncol) - P1/2 | "To our knowledge, we report the first trial combining an ADC with immunotherapy for platinum and anti-PD-1/PD-L1-resistant NPC. BV plus pucotenlimab yielded a notable ORR with exceptionally durable responses and substantially prolonged PFS, alongside manageable toxicities. This regimen may offer a promising anti-PD-1 rechallenge strategy in this population, which is being confirmed in an ongoing, multicenter, randomized controlled, phase III study."

Journal • Dermatology • Hematological Disorders • Nasopharyngeal Carcinoma • Oncology • Pruritus • Solid Tumor

Neoadjuvant Presurgical Becotatug Vedotin (MRG003) Plus Pucotenlimab (HX008) in Oral Cavity Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=32 | Not yet recruiting | Sponsor: Sun Yat-sen University

IO biomarker • New P2 trial • Head and Neck Cancer • Oncology • Oral Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Tunlametinib in Combination With Pucotenlimab and Hydroxychloroquine in NRAS Mutant Melanoma (clinicaltrials.gov) - P2 | N=37 | Recruiting | Sponsor: Sun Yat-sen University

IO biomarker • New P2 trial • Melanoma • Oncology • Solid Tumor • NRAS

Neoadjuvant Pucotenlimab and Becotatug Vedotin for Locally Advanced Penile Cancer (clinicaltrials.gov) - P2 | N=29 | Not yet recruiting | Sponsor: Sun Yat-sen University

IO biomarker • New P2 trial • Genito-urinary Cancer • Oncology • Penile Cancer • Solid Tumor • Squamous Cell Carcinoma

MH-Penile-002: EGFR-ADC (Becotatug Vedotin) Combined With PD-1 Inhibitor (Pucotenlimab) in Neoadjuvant Treatment of Advanced Penile Cancer (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Jiyan Liu | Not yet recruiting ➔ Recruiting

Enrollment open • Genito-urinary Cancer • Oncology • Penile Cancer • Solid Tumor • Squamous Cell Carcinoma

MRG006A Combination Therapy for Advanced Hepatocellular Carcinoma (Phase I/II) (clinicaltrials.gov) - P1/2 | N=160 | Recruiting | Sponsor: Lepu Biopharma Co., Ltd. | Not yet recruiting ➔ Recruiting

Checkpoint inhibition • Enrollment open • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3

An Open-Label, Multicenter, Dose-Escalation and Expansion Clinical Study to Evaluate the Tolerability, Pharmacokinetics and Preliminary Efficacy of MRG002 Combined with HX008 in Patients with HER2-Expressing Locally Advanced or Metastatic Urothelial Carcinoma (ChiCTR) - P1/2 | N=42 | Completed | Sponsor: Peking University Cancer Hospital and Institute; Peking University Cancer Hospital and Institute

New P1/2 trial • Oncology • Solid Tumor • Urothelial Cancer • HER-2 • PD-L1

Phase III Study of Becotatug vedotin Combined with a PD-1 Inhibitor versus PD-1 Inhibitor Monotherapy in EGFR-Positive and CPS ? 1 Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma: A Multicenter, Randomized Controlled Trial (ChiCTR) - P3 | N=430 | Not yet recruiting | Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University; Fifth Affiliated Hospital, Sun Yat-Sen University

Monotherapy • New P3 trial • Head and Neck Cancer • Oncology • Oral Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR

Clinical Application of PD-1 Inhibitor Pucotenlimab for Recurrent Respiratory Papillomatosis (ChiCTR) - P=N/A | N=10 | Not yet recruiting | Sponsor: Eye & ENT hospital of Fudan University; Eye & ENT hospital of Fudan University

New trial • Oncology

CCGLC-013: Combined HAIC, Lenvatinib and Pucotenlimab as Conversion Therapy for Unresectable Intrahepatic Cholangiocarcinoma (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: Tongji Hospital | Trial completion date: Jun 2028 ➔ Jun 2029 | Trial primary completion date: Dec 2026 ➔ Jun 2028

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