#China #Yantai #RemeGen #Disitamab Vedotin #HER2-positive

RemeGen's Groundbreaking Presentation at the 2024 SABCS

On December 12, 2024, during the highly anticipated Poster Spotlight Session titled "Novel HER2 Therapeutics" at the 47th San Antonio Breast Cancer Symposium (SABCS), RemeGen Co., Ltd. revealed encouraging results from a Phase III clinical trial. This trial focused on Disitamab Vedotin (DV), a promising compound for treating patients with HER2-positive advanced breast cancer exhibiting liver metastasis (BCLM). This groundbreaking study is the first prospective randomized Phase III trial of its kind globally.

Professor Jiayu Wang, from the Cancer Hospital at the Chinese Academy of Medical Sciences, presented the findings, capturing the attention of experts from around the world. The SABCS is regarded as one of the premier annual conferences for advancing clinical research in breast cancer, making the presentation of this study particularly significant.

The Urgent Need for New Therapies

Research indicates that approximately 45% of patients with HER2-positive advanced breast cancer experience liver metastases, a condition associated with a dismal prognosis. The 5-year survival rates for these patients hover between a mere 8% to 12%, highlighting a critical gap in effective therapeutic options.

The Phase III study was elegantly designed as a randomized, open-label, multicenter trial, which compared the clinical efficacy and safety of DV against the existing treatment regimen of Lapatinib plus Capecitabine in patients diagnosed with HER2-positive advanced BCLM. A total of 104 individuals were enrolled, with 53 participants receiving DV and 50 receiving the conventional therapy.

All patients had previously undergone treatment with Trastuzumab and Taxanes, making this study pivotal in assessing the next line of defense for these challenging cases. According to the Independent Review Committee’s (IRC) assessment, as of the data cutoff date (December 31, 2023), the results were impressive. DV significantly enhanced progression-free survival (PFS), resulting in a median of 9.9 months compared to just 4.9 months for those on Lapatinib plus Capecitabine (hazard ratio [HR] 0.56 [95% CI 0.35-0.90]). The consistency in results was mirrored in the investigator-assessed PFS, which yielded a similar hazard ratio of 0.62 [95% CI 0.39-0.98].

Moreover, although overall survival (OS) data remained immature, initial trends suggested a positive trajectory for DV. Importantly, the safety profile of DV remained aligned with past experiences, showing no new safety concerns.

Expert Insights and Future Directions

Professor Jiayu Wang noted, "This is the first confirmatory Phase III study demonstrating the promising efficacy of an HER2-targeting antibody-drug conjugate (ADC) in patients suffering from HER2-positive advanced BCLM." The significant clinical advantages observed with DV compared to the traditional combination therapy represent a leap forward. This opens avenues for enhanced treatment options for patients previously treated with Trastuzumab and Taxanes, who have limited alternatives available.

Additionally, the Biologics License Application (BLA) for DV's approval for this indication has been accepted by China's National Medical Products Administration's Center for Drug Evaluation (CDE) in October 2024, with priority review status granted thanks to its breakthrough therapy designation. This momentum underscores RemeGen's commitment to addressing critical healthcare needs and brings hope to those affected by this aggressive cancer form.

In summary, the data from this Phase III study holds substantial promise for altering treatment paradigms in HER2-positive advanced breast cancer with liver metastasis, highlighting RemeGen's pivotal role in advancing therapeutic strategies in oncology. Looking forward, ongoing research and regulatory advancements will be crucial in bringing this innovative treatment to patients in desperate need of effective solutions.