June 8, 2026 - Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. and Merck (known as MSD outside the US and Canada) have launched multiple global Phase 3 clinical trials for SKB264 (sacituzumab tirumotecan / MK-2870), a next-generation antibody-drug conjugate (ADC) originally developed in China, marking one of the largest international expansions of a Chinese-origin ADC drug.
Multiple Phase 3 Trials Underway
The ADC drug is currently being evaluated in several large-scale Phase 3 studies:
- Cervical Cancer Trial (NCT07216703): 1,023 patients, combining SKB264 with pembrolizumab as first-line maintenance treatment. Collaboration with GOG Foundation and European Network of Gynaecological Oncological Trial Groups (ENGOT). Started January 2026, expected completion 2031.
- Non-Small Cell Lung Cancer Trial (NCT06305754): 520 patients with EGFR-mutated advanced NSCLC who progressed on prior EGFR tyrosine kinase inhibitors. Comparing SKB264 vs. pemetrexed and carboplatin. Active but not recruiting, started June 2024.
- HR+/HER2- Breast Cancer Trial (NCT06081959): 376 patients with unresectable locally advanced, recurrent or metastatic HR+/HER2- breast cancer. Started October 2023, comparing SKB264 vs. physician’s choice chemotherapy.
China-US Global Partnership
SKB264 was originally developed by Sichuan Kelun-Biotech, a Chinese pharmaceutical company based in Chengdu, Sichuan Province. Merck (known as MSD outside the US and Canada) licensed the global rights and is now leading international development under the code name MK-2870. This partnership represents a significant milestone in Chinese biotech’s global expansion, with Merck investing heavily in multiple Phase 3 programs across different cancer types.
What is an ADC Drug?
Antibody-drug conjugates (ADCs) are a class of targeted cancer therapies that combine monoclonal antibodies with cytotoxic drugs. The antibody delivers the toxic payload directly to cancer cells expressing specific surface markers, minimizing damage to healthy cells. SKB264 targets TROP-2, a protein overexpressed in many solid tumors including breast, lung, and cervical cancers.
Competitive Landscape
The TROP-2 ADC field is highly competitive, with Gilead’s Trodelvy (sacituzumab govitecan) already approved for breast and urothelial cancer. SKB264 uses a novel linker and payload design that may offer improved safety and efficacy. Early-phase data presented at medical conferences showed promising response rates in heavily pretreated patients.
Global Clinical Trial Network
The Phase 3 trials are recruiting patients across multiple countries:
- United States and Canada
- European Union (through ENGOT network)
- China and Asia-Pacific region
- Latin America
What This Means for Cancer Patients
For patients with advanced breast, lung, or cervical cancer who have exhausted standard treatments, SKB264 offers a potential new therapeutic option. The broad Phase 3 program across multiple tumor types reflects confidence in the drug’s mechanism of action and early clinical results.
Patients interested in participating in clinical trials can search for “MK-2870” or “sacituzumab tirumotecan” on ClinicalTrials.gov to find recruiting sites near them.
Sources
- ClinicalTrials.gov: NCT07216703 (Cervical Cancer)
- ClinicalTrials.gov: NCT06305754 (NSCLC)
- ClinicalTrials.gov: NCT06081959 (Breast Cancer)
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
- Merck Sharp & Dohme LLC