becotarug (JMT101) / CSPC Pharma - LARVOL DELTA

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

BECOME Study at ELCC 2026: Becotarug Plus Osimertinib Shows Survival Benefit in EGFR Exon 20 Insertion NSCLC (OncoDaily) - "The combination of becotarug and osimertinib demonstrated encouraging survival outcomes in this heavily pretreated population...Median overall survival reached 18.0 months, suggesting clinically meaningful benefit in a setting where treatment options are limited...Notably, patients with far-loop insertions demonstrated significantly improved overall survival compared with those with near-loop insertions, with a hazard ratio of 0.58 and a statistically significant difference. Median overall survival in this subgroup reached 25.6 months, compared with 15.6 months in patients with near-loop insertions....Median progression-free survival reached 14.5 months in ctDNA-negative patients, compared with 6.9 months in ctDNA-positive patients."

EGFR exon 20 • P2 data • Non Small Cell Lung Cancer

Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer (clinicaltrials.gov) - P2 | N=31 | Not yet recruiting | Sponsor: Fudan University

New P2 trial • Colorectal Cancer • Oncology • Solid Tumor • BRAF • EGFR • MSI • PD-1 • PD-L1

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

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

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

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

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

Becotatug Vedotin Plus Sintilimab in Locoregionally Advanced NPC (clinicaltrials.gov) - P3 | N=266 | Recruiting | Sponsor: First Affiliated Hospital of Guangxi Medical University

New P3 trial • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Becotatug Vedotin: First Approval. (PubMed, Drugs) - "In October 2025, becotatug vedotin received its first approval in China for the treatment of adult patients with recurrent/metastatic nasopharyngeal carcinoma who have failed at least two lines of systemic chemotherapy and programmed death-1 (PD-1)/programmed death-1 ligand (PD-L1) inhibitor therapy. This article summarizes the milestones in the development of becotatug vedotin leading to this first approval for nasopharyngeal cancer."

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

A Single-arm, Multicenter Clinical Study of Becotatug Vedotin Combined With Zimberelimab in the Treatment of Recurrent and Metastatic Cervical Cancer, Vulvar Cancer and Vaginal Cancer (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

New P2 trial • Cervical Cancer • Gynecologic Cancers • Oncology • Solid Tumor • Vaginal Cancer • Vulvar Cancer

Becotatug vedotin, MRG003, in previously treated recurrent or metastatic nasopharyngeal carcinoma: A multicenter, single-arm, phase IIa trial. (PubMed, Med) - P2 | "MRG003 demonstrated promising efficacy and manageable safety in pretreated R/M NPC patients. This is also the first long-term evaluation of an EGFR-targeted ADC in this population."

Journal • P2a data • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Neoadjuvant Becotatug Vedotin Plus Pucotenlimab and Cisplatin for Locally Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Sir Run Run Shaw Hospital

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

A Phase II Clinical Trial of Anti-EGFR Antibody-drug Conjugate (ADC) Combined With or Without Immune Checkpoint Inhibitors in the Neoadjuvant Treatment of Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: West China Hospital

Checkpoint inhibition • New P2 trial • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Pucotenlimab Combined With Becotatug Vedotin in Advanced Cutaneous Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=38 | Not yet recruiting | Sponsor: Fudan University

New P2 trial • Non-melanoma Skin Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

RearTurbo: Becotatug Vedotin as Adjuvant Therapy For High-risk Nasopharyngeal Carcinoma (clinicaltrials.gov) - P2 | N=227 | Not yet recruiting | Sponsor: Kai Hu | N=150 ➔ 227 | Trial completion date: Dec 2031 ➔ Dec 2032

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

Efficacy and Safety of Becotatug Vedotin (EGFR ADC) plus Pucotenlimab and Cisplatin as Neoadjuvant Therapy for LA-HNSCC (ChiCTR) - P=N/A | N=30 | Not yet recruiting | Sponsor: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine; Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

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

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

Becotatug Vedotin in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck: A Multicenter, Phase IIa Trial. (PubMed, Clin Cancer Res) - P2 | "Becotatug vedotin demonstrated promising antitumor activity with a manageable safety profile in previously heavilytreated R/M SCCHN, particularly the recommended dose of 2.3 mg/kg in patients who had failed platinum-based chemotherapy and PD-1/PD-L1 inhibitors (≤2 prior lines of therapy)."

Journal • P2a data • Constipation • Dermatology • Gastroenterology • Gastrointestinal Disorder • Head and Neck Cancer • Hematological Disorders • Oncology • Pruritus • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

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

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

RearTurbo: Becotatug Vedotin as Adjuvant Therapy For High-risk Nasopharyngeal Carcinoma (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Kai Hu

New P2 trial • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Becotatug (JMT101, Beco) combined with docetaxel (albumin-bound, HB1801) for the treatment of patients (pts) with locally advanced squamous cell non-small cell lung cancer (sqNSCLC): A randomized control phase II study (BATTLE study) (ESMO Asia 2025) - P2/3 | "This study demonstrates the potential of Beco combined with DTX or HB1801 as a novel, effective therapeutic option for pts with high EGFR expression sqNSCLC who have failed first-line therapy. These promising results, coupled with a manageable safety profile, provide strong support for further phase Ⅲ trial (NCT06319313), which may establish this combination as a new standard of care in the second-line treatment of sqNSCLC."

Clinical • Metastases • P2 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Preliminary results of phase II study to evaluate safety and efficacy of becotatug vedotin in combination with pucotenlimab as first-line treatment for recurrent or metastatic squamous cell carcinoma of the head and neck (R/M-SCCHN) (ESMO 2025) - P1/2 | "There is further improved ORR trend as observed at higher dose cohort with 2.3mg/kg. Further follow-up is ongoing to determine the optimal dose of becotatug vedotin."

Clinical • Combination therapy • Metastases • P2 data • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

SYS6002 Plus JMT101 and Enlonstobart Injection in Participants With HNSCC (clinicaltrials.gov) - P2 | N=430 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd. | N=250 ➔ 430 | Initiation date: May 2025 ➔ Aug 2025 | Trial primary completion date: Sep 2027 ➔ Dec 2027

Enrollment change • Trial initiation date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck