ÎçÒ¹¾ç³¡ School of Medicine
A research group at the ÎçÒ¹¾ç³¡ School of Medicine has conducted a multi-institutional, investigator-initiated, phase II clinical trial in Japan (the TEMENOS-2 study). The group was led by Associate Professor Takeru Funakoshi and Assistant Professor Sayuka Arakawa of the Department of Dermatology. The trial evaluated the efficacy and safety of trastuzumab emtansine (T-DM1)¡ªan antibody-drug conjugate (ADC) that targets the protein HER2 (human epidermal growth factor receptor 2) on the surface of cancer cells¡ªin patients with advanced-stage extramammary Paget's disease (EMPD), a rare skin cancer for which no standard treatment has been established.
The trial achieved an objective response rate (the proportion of patients whose tumors shrank) of 92.9%, as assessed by an independent central review committee, demonstrating high therapeutic efficacy along with favorable survival trends and a manageable safety profile. This is the world's first clinical trial to prospectively evaluate the efficacy of a HER2-targeted ADC in advanced-stage extramammary Paget's disease. The findings represent provide prospective clinical data tumor shrinkage, demonstrating the potential for a new treatment option for patients who have had limited effective systemic chemotherapy options.
These findings were published on July 21, 2026 (Japan time) in ESMO Open, the official open-access journal of the European Society for Medical Oncology (ESMO).
For further information, please refer to the following PDF file.