Bicycle Therapeutics presented data at the 2024 San Antonio Breast Conference Symposium (SABCS) highlighting the enhanced anti-tumor activity of their drug, zelenectide pevedotin, in breast cancer patients with NECTIN4 gene amplification. They also announced topline combination data for zelenectide pevedotin plus pembrolizumab in first-line metastatic urothelial cancer (mUC) patients, along with updates on the Duravelo-2 trial and monotherapy data in non-small cell lung cancer (NSCLC). This research focuses on the potential of NECTIN4 gene amplification as a biomarker to identify patients most likely to benefit from zelenectide pevedotin.
These findings have substantial implications for cancer treatment. The identification of NECTIN4 gene amplification as a potential predictive biomarker for zelenectide pevedotin’s efficacy could personalize treatment strategies. This personalized approach could lead to improved outcomes for patients with specific genetic profiles, especially in cancers like triple-negative breast cancer (TNBC) and NSCLC, where effective treatment options are limited. Moreover, the data on zelenectide pevedotin in combination with pembrolizumab in mUC suggests a potential new treatment option for patients ineligible for cisplatin, a standard chemotherapy drug. This could broaden the treatment landscape for mUC and offer an alternative with a potentially improved safety profile compared to existing therapies.
Technically, the data demonstrated a 60% overall response rate for the combination of zelenectide pevedotin and pembrolizumab in first-line mUC, comparable to other therapies. In heavily pretreated breast cancer and NSCLC patients with NECTIN4 gene amplification, the data indicated enhanced anti-tumor activity with zelenectide pevedotin monotherapy. Phase 2/3 Duravelo-2 trial results, including dose selection and topline data, are anticipated in the second half of 2025. Strategically, Bicycle Therapeutics is focusing on developing zelenectide pevedotin in various cancer types using NECTIN4 gene amplification as a patient selection tool. Planned Phase 1/2 trials in breast cancer, lung cancer, and multiple other tumor types in 2025 will further investigate this approach.
This research suggests a potential shift towards more personalized cancer therapies. The emerging importance of NECTIN4 gene amplification as a predictive biomarker may reshape how certain cancers are treated. It could lead to a more targeted and efficient approach, improving outcomes for patients with NECTIN4 amplified tumors. The ongoing and planned trials will provide valuable insights into the efficacy and safety of zelenectide pevedotin across different cancer types and further refine its potential use in a personalized oncology setting. Furthermore, it positions Bicycle Therapeutics as a key player in developing targeted therapies for Nectin-4 associated cancers.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
