- source： CentryMed
- author： CentryMed
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2025.06.26
Shimai Pharma presented a poster titled "Investigator-Initiated Study on Efficacy and Safety of SMET12 Combined with Toripalimab and Chemotherapy in Treatment-Na?ve and Standard Therapy-Resistant Advanced Non-Small Cell Lung Cancer Patients with Positive EGFR Protein Expression, Completed in Collaboration with Professor Zhiyong He's Team at Fujian Cancer Hospital" at the American Society of Clinical Oncology (ASCO 2025) Annual Meeting.
Shimai Pharma conducted this investigator-initiated clinical study of SMET12 combined with PD-1 inhibitor (Toripalimab) and chemotherapy to evaluate the efficacy and safety of the SMET12 + Toripalimab + chemotherapy regimen in treatment-na?ve advanced NSCLC patients, those who failed immune checkpoint inhibitor therapy, and those resistant to targeted therapy.
Application of SMET12 Combined with Toripalimab and Chemotherapy in Treatment-Na?ve or Standard Therapy-Resistant Advanced NSCLC Patients
From March 7, 2024, to January 21, 2025, 32 advanced NSCLC patients were enrolled. 27 were evaluable for efficacy, including:
6 treatment-na?ve patients (Cohort A)
9 patients who failed immune checkpoint inhibitor therapy (Cohort B)
12 EGFR-mutant patients resistant to targeted therapy (Cohort C)
Safety
Grade ≥3 treatment-related adverse events included: leukopenia (19.4%), pneumonia (16.1%), immune-related pneumonia (13.0%), immune-related hepatitis (3.2%), immune-related myositis (3.2%), and anemia (3.2%). The overall safety profile was manageable, with no new safety signals identified for the combination regimen.
Efficacy
Cohort A: Objective Response Rate (ORR) 83.3%, Disease Control Rate (DCR) 100%, median Progression-Free Survival (PFS) 8.3 months
Cohort B: ORR 22.2%, DCR 66.7%, median PFS 4.2 months
Cohort C: ORR 41.7%, DCR 100%, median PFS 7.2 months
The SMET12 + Toripalimab + chemotherapy combination demonstrated favorable tolerability and efficacy in treatment-na?ve NSCLC and EGFR mutation-positive advanced NSCLC patients resistant to TKI therapy. Particularly in Cohort C, results indicate superior anti-tumor activity and disease control in TKI-resistant EGFR-mutant NSCLC patients. Given the limited treatment options for this population, these findings suggest significant clinical potential, supporting future large-scale multicenter registration studies to further validate efficacy in TKI-resistant EGFR-mutant NSCLC patients.
About SMET12
SMET12 is a fully human bispecific antibody targeting tumor cells + immune cells, developed by Shimai Pharma using proprietary antibody screening libraries and a wholly self-owned bispecific antibody platform. It is:
The world's first intravenous EGFR×CD3 bispecific antibody
China's first NMPA-approved EGFR×CD3 bispecific antibody for clinical development
SMET12 has a well-defined anti-tumor mechanism: by simultaneously binding EGFR-positive tumor cells and CD3-positive T cells, it mediates potent tumor-killing activity. Through unique design of the HBiTE platform, it avoids toxicity from homodimerization while optimizing EGFR/CD3 affinity. Preclinical studies demonstrate excellent anti-tumor activity and safety. Consequently, SMET12 will substantially address unmet clinical needs in oncology, offering significant social benefits and enormous market potential.