#USA #SystImmune #Redmond #NPC #Iza-bren

SystImmune's Iza-bren Achieves Key Milestone in NPC Clinical Trials

SystImmune Inc., a prominent biotechnology company focused on cancer treatments, is garnering attention after announcing that its drug, Iza-bren, has successfully met one of its dual primary endpoints in the BL-B01D1-303 trial. This significant achievement was presented during a late-breaking oral session at the 2025 European Society of Medical Oncology (ESMO) Congress.

The BL-B01D1-303 trial is a Phase III, randomized, open-label study that focuses on patients diagnosed with recurrent or metastatic nasopharyngeal carcinoma (NPC), particularly those who have already undergone at least two lines of chemotherapy, including platinum-based treatments. The results showcased that Iza-bren has achieved a BICR-assessed objective response rate (ORR) of 54.6%, a considerable increase when compared to the 27.0% ORR observed with the control group receiving physician's choice of chemotherapy.

Iza-bren, which is a bispecific antibody-drug conjugate (ADC) targeting both epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3), demonstrated a statistically significant and clinically meaningful improvement in response rates. Notably, the median duration of response (DoR) for Iza-bren was reported at 8.5 months, outperforming the 4.8 months reported for traditional chemotherapy approaches.

Furthermore, Iza-bren also showed a median progression-free survival (PFS) of 8.38 months, greatly surpassing the 4.34 months seen in the chemotherapy cohort. These outcomes contribute to a growing body of evidence that highlights the efficacy of Iza-bren as a potential treatment option for patients facing challenging cases of NPC.

Despite the promising results observed in this trial, the overall survival data remains immature. However, SystImmune is optimistic about the implications of these initial findings and their potential to reshape treatment paradigms for advanced cancers such as NPC.

As part of a collaboration between SystImmune and Bristol Myers Squibb, Iza-bren is developed outside of China while being jointly advanced by Biokin within Chinese territories. The results have been received with enthusiasm by the medical community and stakeholders alike, reflecting the significant unmet need in treating NPC, particularly in late-stage cases where the survival rate falls below 10%.

In the trial, Iza-bren displayed a manageable safety profile, with the most frequently observed adverse events being hematological toxicities, which were effectively managed with standard supportive care. Notably, two cases of Grade 2 interstitial lung disease (ILD) occurred in the Iza-bren group, while two patients receiving chemotherapy experienced Grade 3 ILD, signaling that while adverse events were present, the safety profile remained consistent with existing knowledge.

Dr. Jonathan Cheng, Chief Medical Officer of SystImmune, emphasized the significance of these results, stating, "The positive topline results from the first registrational trial of Iza-bren presented at ESMO demonstrated clear clinical benefits of Iza-bren compared to traditional chemotherapy. These data reinforce our confidence in Iza-bren's mechanism of action and therapeutic potential."

The new drug application (NDA) for Iza-bren has now been submitted to the Center for Drug Evaluation (CDE) within the China National Medical Products Administration (NMPA), which will pave the way for further regulatory review and potential market entry.

About Nasopharyngeal Carcinoma (NPC)

NPC is a rare form of head and neck cancer that arises in the nasopharynx and is particularly prevalent in certain regions of Asia, with a strong association to Epstein-Barr virus (EBV) infections. Patients diagnosed with NPC often face limited treatment options and a dire prognosis, highlighting the urgent need for effective therapies like Iza-bren.

Conclusion

The advancements seen with Iza-bren in the BL-B01D1-303 trial represent not just a clinical success for SystImmune but also a beacon of hope for patients battling nasopharyngeal carcinoma. As more data emerges and the drug's journey through regulatory channels progresses, the oncological community watches closely, eager for innovative solutions that could transform patient outcomes.