Iza-Bren Is Approved in China for Recurrent/Metastatic Nasopharyngeal Carcinoma

The Center for Drug Evaluation of China’s National Medical Products Administration has approved izalontamab brengitecan (iza-bren; formerly BL-B01D1) for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who experienced disease progression following prior platinum-based chemotherapy and PD-1/PD-L1–directed therapy.¹

This marks the first regulatory approval for iza-bren, a first-in-class EGFR/HER3 bispecific antibody-drug conjugate (ADC).

This regulatory decision was based on data from the phase 3 PANKU-NPC01/BL-B01D1-303 study (NCT06118333), in which patients who received iza-bren achieved a blinded independent central review–assessed confirmed overall response rate (ORR) of 54.6% (95% CI, 45.2%-63.8%) compared with 27.0% (95% CI, 19.1%-36.0%) among those who received physician’s choice of chemotherapy (odds ratio, 3.3; 95% CI, 1.9-5.8; P < .0001).² Additionally, the median duration of response (DOR) was 8.5 months with iza-bren vs 4.8 months with chemotherapy (HR, 0.43; 95% CI, 0.22-0.83). The median progression-free survival (PFS) values in these respective arms were 8.38 months and 4.34 months (HR, 0.44; 95% CI, 0.32-0.62). The overall survival (OS) data were not yet mature at the time of this analysis.

“This approval represents a significant milestone for patients with recurrent or metastatic NPC and for the development of iza-bren,” Jonathan Cheng, MD, chief medical officer of SystImmune, stated in a news release.¹ “Patients [with NPC] who have progressed following platinum-based chemotherapy and immunotherapy face a poor prognosis with limited treatment options. The approval of iza-bren provides a new therapeutic option that has demonstrated clinically meaningful improvements in tumor response and PFS compared [with] chemotherapy.”

What was the design of PANKU-NPC01?

This randomized, open-label, multicenter trial conducted in China enrolled patients at least 18 years of age and younger than 76 years of age who had recurrent or metastatic NPC and had progressed on a PD-1/PD-L1–directed monoclonal antibody and 2 or more lines of chemotherapy, including at least 1 line of platinum-based chemotherapy.³ Patients also needed to have a life expectancy of at least 3 months, an ECOG performance status of 0 or 1, and no severe cardiac dysfunction.

Patients were randomly assigned to receive intravenous iza-bren for the first 3-week cycle, or capecitabine/gemcitabine/docetaxel for the first 3-week cycle. Patients with clinical benefit were permitted to receive additional cycles of treatment corresponding with their respective arms.

ORR and OS served as the co-primary end points. Secondary end points include PFS, disease control rate, DOR, treatment-emergent adverse effects, and pharmacokinetics.

What was the safety profile of iza-bren in recurrent/metastatic NPC?

Grade 3 or higher treatment-related adverse effects (TRAEs) were observed in 79.9% of patients in the iza-bren arm compared with 61.6% of those in the chemotherapy arm.² Serious TRAEs were reported in 43.4% and 27.0% of patients, respectively. In total, 4 treatment-related deaths occurred in the iza-bren arm. In the investigational arm, dose reductions due to TRAEs (41.8%), TRAEs leading to dose interruption (61.4%), and TRAEs leading to treatment discontinuation (2.6%) were also reported.

Hematologic AEs were reported more frequently with iza-bren vs chemotherapy. Additionally, most nonhematologic TRAEs were grades 1 or 2, and the investigators observed no new safety signals. Two cases of grade 2 interstitial lung disease (ILD) occurred in the iza-bren arm, and 2 cases of grade 3 ILD were reported in the chemotherapy arm.

“[This approval] marks a historic milestone for Biokin and SystImmune as we celebrate the first regulatory approval of iza-bren anywhere in the world,” Yi Zhu, PhD, chairman and chief executive officer of Biokin, added in the news release.¹ “In fact, this is the first bispecific ADC approval of any kind globally. This approval validates our innovative EGFR×HER3 bispecific ADC design and the potential of our proprietary brengitecan-based ADC platform. Most importantly, it brings an important new treatment option to patients with recurrent or metastatic NPC who urgently need better therapies. We thank the patients, investigators, and health care professionals who made this achievement possible and look forward to advancing iza-bren for patients worldwide across multiple tumor types.”

References

1. SystImmune announces first approval of iza-bren for the treatment of recurrent or metastatic nasopharyngeal carcinoma in China. News release. Systimmune. June 22, 2026. Accessed June 24, 2026. https://www.prnewswire.com/news-releases/systimmune-announces-first-approval-of-iza-bren-for-the-treatment-of-recurrent-or-metastatic-nasopharyngeal-carcinoma-in-china-302806766.html
2. Yang Y, Zhou H, Tang L, et al. Iza-bren (BL-B01D1), an EGFR×HER3 bispecific antibody-drug conjugate, versus physician's choice of chemotherapy in heavily pretreated recurrent/metastatic nasopharyngeal carcinoma: a randomized, open-label, multicenter, phase III, pivotal study (BL-B01D1-303). Ann Oncol. 2025;36(suppl 2):S1579. doi:10.1016/j.annonc.2025.09.046
3. A study comparing BL-B01D1 with physician’s choice of chemotherapy in patients with recurrent or metastatic nasopharyngeal carcinoma (PANKU-NPC01). ClinicalTrials.gov. Updated April 17, 2026. Accessed June 24, 2026. https://clinicaltrials.gov/study/NCT06118333