becotarug (JMT101) / CSPC Pharma - LARVOL DELTA

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

Becotatug Vedotin (MRG003) for unresectable locally advanced or metastatic squamous-dominant urothelial malignancies: a prospective, single-arm, open-label, phase II study (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Oncology • Urothelial Cancer

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

CSPC Pharmaceutical…is pleased to announce that the Phase III clinical trial of Becotatug (JMT101)…in combination with osimertinib for the first-line treatment of locally advanced or metastatic non-small cell lung cancer ('NSCLC') harbouring…EGFR ex20ins, has met its primary endpoint at a pre-specified interim analysis, achieving positive topline results (HKEXnews) - "Compared with platinum-based chemotherapy in combination with pemetrexed, the treatment regimen of the Product in combination with osimertinib significantly prolonged the progression-free survival ('PFS') of patients and demonstrated a trend of benefit in overall survival (OS)....According to the pre-specified statistical analysis plan, as reviewed and resolved by the Independent Data Monitoring Committee (IDMC), the PFS benefit in the treatment group of the Product in combination with osimertinib met the pre-specified statistical superiority boundary for the interim analysis and was of clinical significance. In addition, this combination treatment regimen demonstrated a favourable safety profile."

EGFR exon 20 • P3 data • Non Small Cell Lung Cancer

Becotatug Vedotin for Recurrent/Metastatic Nasopharyngeal Carcinoma (Magic-M001): A Multicenter, Randomized Trial. (PubMed, Ann Oncol) - "Among patients with heavily pretreated and immunotherapy-exposed recurrent or metastatic NPC, becotatug vedotin significantly improved ORR and PFS compared with chemotherapy, with comparable toxicity and encouraging but immature OS results."

Journal • Nasopharyngeal Carcinoma • Oncology • Solid Tumor • EGFR

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

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

Becotatug vedotin vs. chemotherapy in pre-heavily treated advanced nasopharyngeal carcinoma: A randomized, controlled, multicenter, open-label study. (ASCO 2025) - P2 | " Eligible pts with R/M NPC had failed ≥2 lines of systemic chemotherapy and PD-(L)1 inhibitor, and were randomized to receive MRG003 (2.3 mg/kg, d1, iv, Q3W) or chemotherapy (capecitabine 1000 mg/m2, po, twice daily, d1-14, Q3W; or docetaxel 75 mg/m2, iv, d1, Q3W). As the first ADC clinical study targeting heavily pretreated R/M NPC, becotatug vedotin demonstrated statistically and clinically meaningful benefits while maintaining a manageable safety profile in this population. This study will lead to a paradigm shift in the treatment of R/M NPC. Sponsor: Lepu Biopharma Co., Ltd."

Clinical • Late-breaking abstract • Metastases • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

JMT101 in combination with irinotecan and SG001 versus regorafenib in patients with metastatic colorectal adenocarcinoma (mCRC): Results of a randomized, controlled, open-label, phase II study. (ASCO 2025) - P2 | "Our results demonstrated a promising response rate and a tolerable safety profile of JMT101 + irinotecan +/- SG001 in pts with mCRC. Preliminary data support continued investigation, with updated results to follow. Clinical trial information: NCT06089330."

Clinical • Combination therapy • IO biomarker • Late-breaking abstract • Metastases • P2 data • Colorectal Adenocarcinoma • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • BRAF • MSI • PD-L1

A phase II study of Becotatug (JMT101) in combination with osimertinib (Osi) in patients (pts) with classical EGFR-mutated non-small cell lung cancer (NSCLC) (BOOSTER Study) (ESMO Asia 2024) - P2 | "Data cutoff date: Mar 19, 2024. Conclusions Beco in combination with Osi showed encouraging antitumor activity and manageable safety in treatment naïve pts with advanced NSCLC harboring classical EGFR mutations."

Clinical • Combination therapy • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Becotarug (JMT101) and osimertinib (Osi) in patients (pts) with platinum-pretreated EGFR exon 20 insertion-mutated (ex20ins) non-small cell lung cancer (NSCLC): Final overall survival (OS) and subgroup analyses from the BECOME phase II study (ELCC 2026) - P2 | "Legal entity responsible for the study Shanghai JMT-Bio Technology Co., Ltd. Funding Shanghai JMT-Bio Technology Co., Ltd."

Clinical • EGFR exon 20 • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Phase II study of becotarug (JMT101) combined with osimertinib in patients (pts) with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion (ex20ins) mutations (BECOME study) (ELCC 2024) - P2 | "Most TRAEs were EGFR target-related toxicities that can be well managed, with only 5% of pts discontinued permanently due to TRAEs. Conclusions Becotarug in combination with osimertinib showed manageable safety and compelling antitumor activity in pts with NSCLC harboring EGFR ex20ins mutations."

Clinical • EGFR exon 20 • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • 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

An evaluation of becotatug vedotin for the treatment of recurrent or metastatic nasopharyngeal cancer. (PubMed, Expert Opin Biol Ther) - "Becotatug vedotin demonstrates promising antitumor activity in R/M NPC and represents a potentially valuable addition to the therapeutic drug. Future investigations should define the most effective dosing regimens and explore rational combination approaches, including integration into front-line."

Journal • Review • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

A randomized, non-comparative, multicenter phase II trial of neoadjuvant becotatug vedotin alone or combined with immune checkpoint inhibitors (penpulimab/ivonescimab) in resectable locally advanced head and neck squamous cell carcinoma. (ASCO 2026) - P2 | "The primary endpoint is Pathologic Complete Response (PCR).Secondary endpoints include major Pathological Response (MPR), objective Response Rate (ORR), 1-year Event-Free Survival (EFS) Rate, 2-year Overall Survival (OS) Rate, treatment-related safety, and predictive biomarkers. Research Sponsor: Lepu Biopharma Co., Ltd."

Checkpoint inhibition • Clinical • IO biomarker • Metastases • P2 data • Head and Neck Cancer • Immunology • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Becotatug vedotin plus pucotenlimab as first-line therapy in patients with recurrent or metastatic nasopharyngeal carcinoma: A phase II clinical trial. (ASCO 2026) - P2 | "Secondary endpoints include objective response rate (ORR), disease control rate (DCR), duration of response (DoR), overall survival (OS), treatment-related safety, and predictive biomarkers. Research Sponsor: Lepu Biopharma Co., Ltd."

Clinical • IO biomarker • Metastases • P2 data • Immunology • Nasopharyngeal Carcinoma • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor

Comparing becotarug plus osimertinib with a real-world osimertinib therapy cohort in platinum-refractory, advanced non–small cell lung cancer with EGFR exon 20 insertion. (ASCO 2026) - P, P1, P2 | "This study further supports the efficacy and tolerability of becotarug plus osimertinib in patients with platinum-refractory, EGFR 20ins-positive NSCLC."

Clinical • EGFR exon 20 • Metastases • Real-world • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Recent highlights and breakthroughs in immunotherapy for head and neck cancers. (PubMed, Curr Opin Oncol) - "Recent advances highlight a rapid surge in positive immunotherapy trials across different head and neck cancer entities, with clinical benefit observed both when immune checkpoint inhibitors are moved earlier in the disease course and when they are combined with agents targeting resistance mechanisms or enabling more precise drug delivery to tumors."

IO biomarker • Journal • Head and Neck Cancer • Nasopharyngeal Carcinoma • Non-melanoma Skin Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Thyroid Gland Anaplastic Carcinoma • Thyroid Gland Carcinoma • BRAF

The Efficacy and Safety of Pucotenlimab (PD-1) Combined With Becotatugvedotin (EGFR-ADC) in Advanced Cholangiocarcinoma (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Sir Run Run Shaw Hospital

New P2 trial • Biliary Cancer • Cholangiocarcinoma • Gallbladder Cancer • Oncology • Solid Tumor • EGFR

RearTurbo: Becotatug Vedotin as Adjuvant Therapy For High-risk Nasopharyngeal Carcinoma (clinicaltrials.gov) - P2 | N=218 | Not yet recruiting | Sponsor: Kai Hu | Trial completion date: Dec 2032 ➔ Apr 2033 | Trial primary completion date: Dec 2029 ➔ Apr 2030

Trial completion date • Trial primary completion date • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

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 | Not yet recruiting | Sponsor: Jiyan Liu

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

Efficacy and Safety of SBRT Combined With Becotatug Vedotin in EGFR-Positive Metastatic Tumor Patients With Oligometastases (clinicaltrials.gov) - P3 | N=200 | Not yet recruiting | Sponsor: Ming-Yuan Chen

New P3 trial • Oncology • EGFR