What's Happening?
SystImmune Inc. and Bristol Myers Squibb have announced the first global Phase I results of their bispecific antibody-drug conjugate, iza-bren, at the European Society for Medical Oncology Congress 2025.
The study, known as US-Lung-101, evaluated the safety and efficacy of iza-bren in patients with heavily pre-treated metastatic or unresectable advanced non-small cell lung cancer (NSCLC) and other solid tumors. The results showed promising antitumor activity, particularly in patients with EGFR mutant and wildtype NSCLC. The study involved 107 patients, and the most common side effects were manageable blood-related issues. The drug has been granted breakthrough therapy designation by the U.S. FDA for patients with previously treated EGFR-mutated NSCLC.
Why It's Important?
The development of iza-bren is significant as it offers a potential new treatment option for patients with difficult-to-treat cancers, particularly those who have exhausted other therapies. The promising results from the Phase I study suggest that iza-bren could become a valuable tool in the fight against various types of cancer, including NSCLC, which is a leading cause of cancer-related deaths. The collaboration between SystImmune and Bristol Myers Squibb highlights the importance of partnerships in advancing cancer treatment research and development. If successful, iza-bren could improve outcomes for patients with limited treatment options, addressing a critical need in oncology.
What's Next?
Global registrational studies for iza-bren are ongoing, focusing on first-line metastatic triple-negative breast cancer, second-line metastatic EGFRmt NSCLC, and second-line metastatic urothelial cancer. These studies aim to further evaluate the drug's efficacy and safety across different cancer types. The results of these studies will be crucial in determining the future of iza-bren as a treatment option. Additionally, the ongoing collaboration between SystImmune and Bristol Myers Squibb will continue to explore the potential of iza-bren in other indications, potentially expanding its use in oncology.
