2024 SABCS｜Results Unveiled for the Phase III Study of Disitamab Vedotin in Treating HER2-Positive Advanced Breast Cancer with Liver Metastasis

Rhea-AI Summary

RemeGen presented groundbreaking results from its Phase III study of Disitamab Vedotin (DV) for HER2-positive advanced breast cancer with liver metastasis at the 47th San Antonio Breast Cancer Symposium. The study, involving 104 patients, compared DV against Lapatinib plus Capecitabine in patients previously treated with Trastuzumab and Taxanes.

Key findings showed DV significantly improved progression-free survival (9.9 months vs. 4.9 months), with a hazard ratio of 0.56. The overall survival data, while not yet mature, showed a positive trend favoring DV. This marks the first global prospective randomized Phase III study demonstrating significant efficacy of a HER2-targeting ADC in this patient population, where the 5-year survival rate is typically only 8% to 12%.

The Biologics License Application for DV has been accepted by China's National Medical Products Administration with priority review status.

Positive

• Significant improvement in progression-free survival (9.9 vs 4.9 months)
• First successful Phase III study for HER2-targeting ADC in liver metastasis
• BLA filing accepted with priority review status in China
• Positive trend in overall survival data
• Manageable safety profile with no new safety signals

Negative

• Overall survival data still immature
• to patients previously treated with Trastuzumab and Taxanes

YANTAI, China, Dec. 12, 2024 /PRNewswire/ -- On the morning of December 12, 2024 (UTC-6), at the Poster Spotlight Session "Novel HER2 Therapeutics" of the 47th San Antonio Breast Cancer Symposium (SABCS), RemeGen Co. Ltd. ("RemeGen") (9995.HK, 688331.SH) presented for the first time the data from a phase III study (RC48-C006, NCT03500380) of Disitamab Vedotin (DV) in treating patients with HER2-positive advanced breast cancer with liver metastasis (BCLM). This is the first prospective randomized phase III study globally on a HER2-targeting ADC that demonstrated significant efficacy in patients with HER2-positive advanced BCLM. Professor Jiayu Wang from the Cancer Hospital, Chinese Academy of Medical Sciences presented and discussed the study. SABCS is one of the largest and most influential annual conferences focusing on advances in breast cancer clinical research, and this RemeGen sponsored study attracted the attention of experts worldwide.

Data shows that about 45% of patients with HER2-positive advanced breast cancer have liver metastasis. This subset has a poor prognosis with a 5-year survival rate of only 8% to 12%, for whom no satisfactory therapies are available now.

This is a randomized, open-label, multicenter phase III study comparing the efficacy and safety of DV versus Lapatinib plus Capecitabine in patients with HER2-positive advanced BCLM. A total of 104 patients were enrolled, of whom 53 received DV and 50 received Lapatinib plus Capecitabine. All patients had previously been treated with Trastuzumab and Taxanes.

As of data cutoff date (December 31, 2023), according to the assessment by the Independent Review Committee (IRC), DV significantly improved progression-free survival (PFS) versus Lapatinib plus Capecitabine (median: 9.9 months vs. 4.9 months; hazard ratio [HR]: 0.56 [95% CI: 0.35-0.90]), which is consistent with the investigator-assessed PFS (HR: 0.62 [95% CI: 0.39-0.98]). The overall survival (OS) data, though immature, indicated a benefit trend in favor of DV. The safety profile was consistent with past DV use experience, with no new safety signals detected.

"This is the first confirmatory phase III study that demonstrated promising efficacy of an HER2-targeting ADC in patients with HER2-positive advanced BCLM," observed Professor Jiayu Wang. DV demonstrated clinically meaningful benefit compared with Lapatinib plus Capecitabine and a manageable safety profile, potentially offering a promising new treatment option for patients with HER2-positive advanced BCLM previously treated with Trastuzumab and Taxanes. The Biologics License Application (BLA) filing for this indication of DV has been accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration in October 2024 and priority review was granted based on the breakthrough therapy designation.

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SOURCE RemeGen Co., Ltd

FAQ

What were the key results of RemeGen's Phase III Disitamab Vedotin trial for breast cancer?

The trial showed DV improved progression-free survival to 9.9 months compared to 4.9 months for Lapatinib plus Capecitabine, with a hazard ratio of 0.56, in HER2-positive advanced breast cancer with liver metastasis patients.

How many patients participated in RemeGen's Phase III breast cancer study?

The study enrolled 104 patients total, with 53 receiving Disitamab Vedotin and 50 receiving Lapatinib plus Capecitabine.

What is the current status of Disitamab Vedotin's regulatory approval in China?

The Biologics License Application for Disitamab Vedotin was accepted by China's National Medical Products Administration in October 2024 with priority review status.

What is the survival rate for HER2-positive breast cancer patients with liver metastasis?

According to the data, patients with HER2-positive advanced breast cancer with liver metastasis have a poor prognosis with a 5-year survival rate of only 8% to 12%.

When was the data cutoff date for RemeGen's Phase III breast cancer trial?

The data cutoff date for the Phase III trial was December 31, 2023.