becotarug (JMT101) / CSPC Pharma - LARVOL DELTA

A real-world study on first-line (1L) treatment for 46 advanced lung adenocarcinoma patients harbouring epidermal growth factor 20 insertion mutation (EGFR ex20ins). (ASCO 2025) - P=N/A | "In NTT cohort, patients received sunvozertinib, furmonertinib or combination therapy of JMT101 and osimertinib. For advanced lung adenocarcinoma patients harbouring EGFR ex20ins, novel targeted drug-based therapies represented an effective treatment option and were well tolerated."

Clinical • EGFR exon 20 • Metastases • Real-world • Real-world evidence • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • 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

JMT101 GRANTED BREAKTHROUGH THERAPY DESIGNATION IN CHINA FOR THE TREATMENT OF COLORECTAL CANCER (CSPC Press Release) - "The board of directors (the 'Board') of CSPC Pharmaceutical Group Limited...is pleased to announce that JMT101, developed by the Group, has been granted Breakthrough Therapy Designation by the Center for Drug Evaluation of the National Medical Products Administration of the People’s Republic of China for the proposed indication of use in combination with irinotecan for the treatment of RAS, RAF, EGFR ECD and PIK3CA exon 20 wild-type advanced colorectal cancer after failure of standard treatment in second-line or beyond (the 'Indication')."

Breakthrough therapy • EGFR exon 20 • Colorectal Cancer

SYS6002 Plus JMT101 and Enlonstobart Injection as First-Line Treatment for HNSCC (clinicaltrials.gov) - P2 | N=250 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

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

JMT101 Combined With Mitoxantrone Liposome for Nasopharyngeal Cancer (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Shanghai JMT-Bio Inc.

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

A Randomized, Controlled, Open-label Phase Ⅱ study of Becotatug (JMT101) Combined with Docetaxel (Albumin-Bound, HB1801) for Treatment of Patients (pts) with Locally Advanced/Recurrent or Distant Metastatic Squamous Cell Non-Small Cell Lung Cancer (sqNSCLC) (BATTLE study) [WITHDRAWN] (ELCC 2025) - No abstract available

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

A phase II, randomized study of JMT101 in combination with irinotecan and SG001 versus regorafenib in patients with metastatic colorectal adenocarcinoma (mCRC). (ASCO-GI 2025) - P2 | "Eligible patients are histologically confirmed mCRC without MSI-H/dMMR, wild-type RAS and BRAF, who progressed on at least 2 prior systemic therapy with chemotherapy based on 5-FU with oxaliplatin and irinotecan, with or without cetuximab and bevacizumab (both parts); no prior treatment with regorafenib, fruquintinib, or TAS-102 (part II)...Secondary endpoints include JMT101 and SG001 pharmacokinetic profile, antidrug antibodies (ADA) (both parts), disease control rate (DCR), duration of response (DOR), progression free survival (PFS), and overall survival (OS), as well as safety (part II). Prespecified goal for safety run-in part was met; randomized treatment part accrual began in February 2024."

Clinical • Combination therapy • Metastases • P2 data • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • MSI

Antibodies to watch in 2025. (PubMed, MAbs) - "In particular, we report on 21 antibody therapeutics granted a first approval in at least one country or region during 2024, including bispecific antibodies tarlatamab (IMDELLTRA®), zanidatamab (Ziihera®), zenocutuzumab (BIZENGRI®), odronextamab (Ordspono®), ivonescimab (®), and antibody-drug conjugate (ADC) sacituzumab tirumotecan (®). We also discuss 30 investigational antibody therapeutics for which marketing applications were undergoing review by at least one regulatory agency, as of our last update on December 9, 2024, including ADCs datopotamab deruxtecan, telisotuzumab vedotin, patritumab deruxtecan, trastuzumab botidotin, becotatug vedotin, and trastuzumab rezetecan. Of 178 antibody therapeutics we include in the late-stage pipeline, we summarize key data for 18 for which marketing applications may be submitted by the end of 2025, such as bi- or multispecific antibodies denecimig, sonelokimab, erfonrilimab, and anbenitamab. Key..."

Journal • Review • Oncology

A Clinical Study of JMT101 in Combination With Osimertinib Versus Osimertinib Alone as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Harboring Epidermal Growth Factor Receptor (EGFR) Sensitive Mutations (clinicaltrials.gov) - P3 | N=516 | Recruiting | Sponsor: Shanghai JMT-Bio Inc.

Combination therapy • Metastases • New P3 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

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

JMT101 Combined With Osimertinib in Patients With Stage Ⅲb-Ⅳ Non-small Cell Lung Cancer (NSCLC) Characterized by Epithermal Growth Factor Receptor (EGFR) Common Mutations (clinicaltrials.gov) - P2 | N=161 | Active, not recruiting | Sponsor: Shanghai JMT-Bio Inc.

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

JMT101 in Combination With Osimertinib, Versus Cisplatin-pemetrexed in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Characterized by Epithermal Growth Factor Receptor (EGFR) Exon 20ins Mutations (clinicaltrials.gov) - P3 | N=398 | Not yet recruiting | Sponsor: Shanghai JMT-Bio Inc.

Combination therapy • EGFR exon 20 • Metastases • New P3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

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

Efficacy and Safety of JMT101 Combined Wth Docetaxel / HB1801 in Patients With Squamous Cell Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2/3 | N=534 | Not yet recruiting | Sponsor: Shanghai JMT-Bio Inc.

New P2/3 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Becotarug Plus Osimertinib Elicits Responses in EGFR Exon 20 Insertion+ NSCLC (OncLive) - P2 | N=155 | BECOME (NCT05132777) | Sponsor: Shanghai JMT-Bio Inc. | "The combination of becotarug (JMT101) and osimertinib (Tagrisso) induced antitumor activity with a manageable safety profile in patients with non–small cell lung cancer (NSCLC) harboring EGFR exon 12 insertion mutations, according to findings from the phase 2 BECOME study (NCT05132777) presented during the 2024 European Lung Cancer Congress. The doublet led to an objective response rate (ORR) of 50.0% (95% CI, 40.4%-59.6%) in the intention-to-treat (ITT) population (n = 112) comprised entirely of partial responses. Moreover, 29.5% of patients achieved stable disease as their best overall response to treatment, 8.9% experienced disease progression, and 11.6% were not evaluable. The disease control rate (DCR) was 79.5% (95% CI, 70.8%-86.5%)."

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

A Study of JMT101 in Patients With Metastatic Colorectal Cancer (clinicaltrials.gov) - P2 | N=102 | Not yet recruiting | Sponsor: Shanghai JMT-Bio Inc.

Metastases • New P2 trial • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • EGFR • MSI

Phase 1b trial of anti-EGFR antibody JMT101 and Osimertinib in EGFR exon 20 insertion-positive non-small-cell lung cancer. (PubMed, Nat Commun) - P1 | "Intracranial disease control rate is 87.5%. Confirmed intracranial objective response rate is 25%."

EGFR exon 20 • Journal • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Phase 1b trial of anti-EGFR antibody JMT101 and Osimertinib in EGFR exon 20 insertion-positive non-small-cell lung cancer (Nat Commun, Nature) - P1 | N=48 | NCT04448379 | Sponsor: Shanghai JMT-Bio Inc. | "A total of 121 patients are enrolled to receive JMT101 plus osimertinib 160 mg. The most common adverse events are rash (76.9%) and diarrhea (63.6%). The confirmed objective response rate is 36.4%. Median progression-free survival is 8.2 months. Median duration of response is unreached. Subgroup analyses were performed by clinicopathological features and prior treatments. In patients with platinum-refractory diseases (n = 53), confirmed objective response rate is 34.0%, median progression-free survival is 9.2 months and median duration of response is 13.3 months. Responses are observed in distinct 20ins variants and intracranial lesions. Intracranial disease control rate is 87.5%. Confirmed intracranial objective response rate is 25%."

P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Phase 1b trial of anti-EGFR antibody JMT101 and Osimertinib in EGFR exon 20 insertion-positive non-small-cell lung cancer (Nat Commun, Nature) - P1 | N=48 | NCT04448379 | Sponsor: Shanghai JMT-Bio Inc. | "A total of 121 patients are enrolled to receive JMT101 plus osimertinib 160 mg. The most common adverse events are rash (76.9%) and diarrhea (63.6%). The confirmed objective response rate is 36.4%. Median progression-free survival is 8.2 months. Median duration of response is unreached. Subgroup analyses were performed by clinicopathological features and prior treatments. In patients with platinum-refractory diseases (n = 53), confirmed objective response rate is 34.0%, median progression-free survival is 9.2 months and median duration of response is 13.3 months. Responses are observed in distinct 20ins variants and intracranial lesions. Intracranial disease control rate is 87.5%. Confirmed intracranial objective response rate is 25%."

P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

JMT101 Combined With Afatinib in Patients With Advanced Esophageal Squamous Cell Carcinoma After Standard Therapy (clinicaltrials.gov) - P1; N=50; Recruiting; Sponsor: Peking University

Clinical • New P1 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Efficacy and Safety of JMT101 Combined With Osimertinib in Patients With Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2; N=155; Not yet recruiting; Sponsor: Shanghai JMT-Bio Inc.

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

[VIRTUAL] JMT101 Combined With Afatinib or Osimertinib in Patients (pts) With NSCLC With EGFR Exon 20 Insertion Mutations (IASLC-WCLC 2021) - "The abstract for this presentation has not been submitted or is currently under embargo until August 18, 2021 at 16:00 MDT."

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

Efficacy and Safety of JMT101 in Patients With Advanced Solid Tumor (clinicaltrials.gov) - P1; N=259; Recruiting; Sponsor: Shanghai JMT-Bio Inc.

Clinical • New P1 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF

[VIRTUAL] A multi-center, open label, phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetics of recombinant humanized anti-EGFR monoclonal antibody injection (JMT101) in patients (pts) with advanced colorectal cancer (ACC) (ESMO 2020) - No abstract available

Clinical • P1 data • PK/PD data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor