Merck Launches 14th Global Phase III Trial of Sacituzumab Tirumotecan in High-Risk Early Breast Cancer

▎Armstrong

May 13, 2025MSD has registered a Phase III clinical trial on Clinicaltrials.gov for the new Trop2 ADC drug Luskamtamab (MK-2870, SKB264) + Keytruda followed by carboplatin/paclitaxel combined with Keytruda as neoadjuvant therapy for high-risk, early-stage triple-negative breast cancer or HR-low+/HER2- breast cancer. This marks the 14th global Phase III clinical trial MSD has initiated around Luskamtamab.

This Phase III clinical trial plans to enroll 2,400 participants.High-risk, early-stage triple-negative breast cancer or HR-low+/HER2- breast cancer patients are expected to complete initial trials by 2033.

• Trofuse-004: Previously treatedEGFR mutation or other mutations in advanced or metastatic non-squamous non-small cell lung cancer;

• Trofuse-005: Previously treated with platinum-based chemotherapy and immunotherapyEndometrial cancer;

• Trofuse-007：High PD-L1 expression (TPS≥50%) metastatic non-small cell lung cancer;

• Trofuse-009：Advanced non-squamous non-small cell lung cancer with EGFR mutations, progressed after EGFR-TKI treatment;

• Trofuse-010: InoperableLocally Advanced or Metastatic HR+/HER2- Breast Cancer;

• Trofuse-011: Untreated locally recurrent or metastatic triple-negative breast cancer;

• Trofuse-012: Adjuvant treatment for triple-negative breast cancer that did not achieve pathological complete response after previous neoadjuvant therapy and surgery;

• Trofuse-015：Advanced or metastatic gastric esophageal adenocarcinoma;

• Trofuse-019: Adjuvant treatment for non-small cell lung cancer that has not achieved pathological complete response after surgery;

• Trofuse-020: Recurrent or metastatic cervical cancer;

• TroFuse-022：Platinum-sensitive recurrent or metastatic ovarian cancer;

• Trofuse-023: Metastatic squamous non-small cell lung cancer;

• Trofuse-032：High-risk, early-stage triple-negative breast cancer or HR-low+/HER2- breast cancer;

• Trofuse-033: Mismatch repair proficient endometrial cancer.

Summary

Since October 2023, MSD has intensively launched 14 global Phase III clinical trials of Lutrisocept, covering multiple tumor types.As MSD mentioned at ESMO2023, lutetium Lu 177 vipivotide tetraxetan has become a key foothold in its oncology portfolio and one of the significant entry points for clinical breakthroughs.MSDFull PowerTo advance the clinical development of Luku Sandbox Monoclonal Antibody, it is necessary to cover a broader range of cancer types and actively expand from later-line to front-line treatment.