On December 17, Kipsbiopharma (Kipspharma) announced that its subsidiary Bigthink Therapeutics (hereafter Bigthink) has demonstrated the safety and tolerability of its breast cancer treatment "Nerlynx" (active ingredient: neratinib) for Korean patients through real-world data (RWD).
Bigthink stated on December 17 that the results of a Korean RWD study on its early breast cancer extended adjuvant therapy, Nerlynx, were presented at the "San Antonio Breast Cancer Symposium (SABCS) 2025," held from December 9 to 12. SABCS is one of the world’s largest conferences dedicated to breast cancer research.
This study was a multicenter trial led by Professors Moon Yonghwa and Kim Seulgi from the Division of Hematology and Oncology at Bundang CHA Hospital, with participation from four major medical institutions in Korea.
According to the presentation, the research team analyzed 48 patients with hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-positive early breast cancer who were prescribed Nerlynx from May 2022 to June 2025. Among all patients, 77.1% had tumors measuring 2 cm or larger (T stage 2 or above).
This study drew academic attention because it included a significant number of patients treated with the latest standard therapies, which were not present in the original "ExteNET" approval trial for Nerlynx. Among the 48 patients, 33.3% (16 patients) received a combination of trastuzumab and pertuzumab (active ingredient: pertuzumab) as adjuvant therapy after surgery, 41.7% (20 patients) received Kadcyla (active ingredient: trastuzumab emtansine), 22.9% (11 patients) received trastuzumab alone, and one patient received Enhertu (active ingredient: trastuzumab deruxtecan).
The results showed that even after treatment with these latest therapies, using Nerlynx as extended adjuvant therapy posed no issues with safety or tolerability. A total of 95.8% of patients started at the recommended dose of 240 mg, and the rate of permanent discontinuation due to adverse events was low at 8.3%.
Initial efficacy indicators were also positive. In a subgroup analysis of 34 patients who could be followed for 24 months or longer, there were no cases of invasive disease recurrence observed.
Meanwhile, since its introduction to Korea in 2022, Nerlynx has demonstrated a 51% reduction in recurrence risk and a 59% reduction in the risk of brain metastasis in HER2-positive early breast cancer patients. As a result, it has become a standard treatment option for high-risk patients in Korea.
Kim Hayong, CEO of Bigthink, stated, "We are focusing on expanding our portfolio to strengthen our expertise in cancer therapeutics," adding, "We will soon launch a new range of anticancer products with significant sales potential in the market."
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