TS-1 Approved as Adjuvant Therapy for High-Risk Breast Cancer in Japan

On November 24, 2022, Taiho Pharmaceutical Co., Ltd. announced that the oral anticancer agent TS-1 (Teysuno / S-1) has received approval in Japan for an additional indication: adjuvant treatment for patients with hormone receptor-positive (HR+), HER2-negative, high-risk early breast cancer.

Clinical Evidence: POTENT Trial

The approval is based on the results of the POTENT Phase 3 clinical trial, which involved 1,959 patients with HR+/HER2- early breast cancer. The trial compared two adjuvant strategies:

1. Standard Endocrine Therapy for 5 years.
2. Standard Endocrine Therapy (5 years) plus TS-1 for 1 year.

Key Findings

The trial met its primary endpoint, demonstrating a clinically significant improvement in invasive disease-free survival (iDFS) for patients receiving the combination of endocrine therapy and TS-1. The safety profile observed was consistent with previous reports for TS-1, with no new major safety concerns identified in this patient population.

Future Outlook

Taiho Pharmaceutical emphasized its commitment to providing TS-1 as a new treatment option to help improve outcomes and provide better quality of care for breast cancer patients.

Source: Taiho Pharmaceutical Press Release - TS-1 Approval for Breast Cancer

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