The first patient has been dosed in the WIN-B clinical trial, a groundbreaking study investigating the combination of Debiopharm's WEE1 inhibitor Debio 0123 with Gilead's Trodelvy for advanced breast cancer treatment. This Phase Ib/II multi-center trial aims to evaluate the safety and preliminary efficacy of this novel combination in patients with hormone receptor-positive (HR+)/HER2-negative and triple-negative breast cancers.
Strategic Partnership and Trial Design
The trial, sponsored by MEDSIR and fully funded by Debiopharm, represents a significant collaboration between the Swiss biopharmaceutical company and the Spanish-US research organization. Gilead Sciences is providing Trodelvy (sacituzumab govitecan-hziy) for the study, which follows promising preclinical results presented at the 2024 American Association for Cancer Research (AACR) annual meeting.
"Exploring novel combinations can lead to breakthroughs for cancer patients," stated Esteban Rodrigo Imedio, Executive Medical Director of Oncology at Debiopharm. "We are looking forward to seeing the potential benefits of this combination therapy for patients with a critical unmet medical need such as advanced-stage breast cancer."
Addressing Critical Unmet Needs
HR+/HER2- breast cancer, accounting for 70% of all cases, presents significant treatment challenges. With a five-year relative survival rate of only 30% for metastatic disease, and frequent development of resistance to current therapies, new treatment approaches are urgently needed. Nearly one-third of early-stage breast cancer cases eventually progress to metastatic disease.
Triple-negative breast cancer (TNBC), representing 10-15% of breast cancers, poses additional challenges due to its aggressive nature and high risk of metastasis. TNBC patients face significantly higher relapse and mortality rates compared to other breast cancer types.
Innovative Treatment Approach
Debio 0123 is a brain-penetrant, highly selective WEE1 kinase inhibitor that targets a key regulator of cell cycle checkpoints. When combined with DNA-damaging agents like Trodelvy, it may enhance anti-tumor activity by disrupting cancer cells' ability to repair DNA damage.
Dr. Javier Cortés, MEDSIR Senior Scientific Lead, expressed optimism about the collaboration: "This partnership represents an exciting step forward in developing new treatment options for hard-to-treat breast cancers. I believe our work with Debio 0123 and Trodelvy holds great promise for patients with hard-to-treat cancers."
Trial Implementation and Future Outlook
The WIN-B trial marks an important milestone in breast cancer research, particularly for patients who have exhausted current treatment options. While the combination of Debio 0123 and sacituzumab govitecan-hziy remains investigational and has not yet received regulatory approval, the study represents a significant step toward developing more effective treatments for advanced breast cancer.
