SystImmune's Iza-bren Gains Second Regulatory Approval in China for Advanced Esophageal Cancer Treatment
SystImmune Inc., a prominent name in biopharmaceutical innovation, has announced that its parent company, Sichuan Biokin Pharmaceutical Co., Ltd., has received crucial regulatory approval from China's National Medical Products Administration (NMPA) for its drug Iza-bren. This latest approval marks a significant milestone as it allows the drug to be used for adult patients suffering from recurrent or metastatic esophageal squamous cell carcinoma (ESCC) who have not seen success with prior platinum-based chemotherapy or PD-1/PD-L1 inhibitor therapies.
Iza-bren, known scientifically as izalontamab brengitecan, is now recognized as a first-in-class EGFR × HER3 bispecific antibody-drug conjugate (ADC). This approval expands its clinical use, following its recent endorsement for treating recurrent or metastatic nasopharyngeal carcinoma (NPC). It solidifies Iza-bren’s reputation as a versatile treatment option with significant potential across multiple solid tumor types.
The approval came on the back of promising results from the pivotal PANKU-Esophagus01 study (BL-B01D1-305), which demonstrated that Iza-bren not only met its primary endpoints for progression-free survival (PFS) and overall survival (OS) but did so convincingly compared to traditional chemotherapy. The outcomes indicated statistically significant benefits, signaling a notable step forward in cancer treatment protocols.
For instance, the study revealed that the median overall survival with Iza-bren reached 9.8 months as opposed to just 7.2 months with standard chemotherapy (HR=0.64, 95% CI 0.49–0.83; p=0.0004). Similarly, the median progression-free survival statistics favored Iza-bren, achieving 4.2 months versus the 2.0 months seen with chemotherapy (HR=0.50; 95% CI 0.40-0.63; p<0.0001).
Furthermore, Iza-bren displayed a commendably manageable safety profile, with only 2% of patients discontinuing treatment due to adverse events. Both the incidence of interstitial lung disease (ILD) among patients receiving Iza-bren and chemotherapy remained low, with rates of all grade ILD at 1.6% and 0.4% respectively.
Dr. Yi Zhu, Chairman and CEO of Biokin, remarked, "Today's approval marks an essential achievement for Iza-bren and underscores the potential of our EGFR × HER3 bispecific ADC platform to tackle significant unmet needs in challenging cancer diagnoses." He added gratitude towards the involved patients and professionals who contributed to this milestone.
"Patients struggling with recurrent or metastatic ESCC have historically encountered limited treatment options and dismal outcomes after first-line therapies," explained Dr. Jonathan Cheng, Chief Medical Officer of SystImmune. "The impressive results from the BL-B01D1-305 study establish Iza-bren as a pivotal new option for these patients in need. Our commitment to advancing Iza-bren's global development across various tumor types remains strong."
Iza-bren is currently undergoing evaluation in several global clinical studies for various solid tumor indications, which include non-small cell lung cancer, breast cancer, and urothelial cancer, amongst others that express EGFR/HER3.
The PANKU-Esophagus01 study involved a randomized, open-label, multicenter phase 3 clinical trial assessing Iza-bren against chemotherapy for patients who had already undergone progressive disease following platinum-based chemotherapy and PD-1/PD-L1 inhibitors. A total of 497 patients were recruited across 80 study centers in China, and the encouraging findings were shared during a presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.
Esophageal squamous cell carcinoma (ESCC) is notably concerning, ranking as the seventh most diagnosed cancer globally and the sixth leading cause of cancer deaths. Particularly in China, this form of cancer accounts for around 90% of diagnosis, highlighting the urgent need for effective therapies. Even with existing treatments, many patients face progression of their disease within short timeframes, underscoring the importance of innovative solutions.
Iza-bren stands out as it uniquely targets both EGFR and HER3, known contributors to cancer cell proliferation and survival. Its dual-action mechanism effectively disrupts growth signaling, and through antibody-mediated processes, its therapeutic payload induces cancer cell death. SystImmune, located in Redmond, WA, specializes in developing advanced cancer treatments and holds several clinical and preclinical assets poised for innovation.
As forward-looking projections for Iza-bren continue to develop, the focus remains on its potential to redefine the standards of care for patients battling advanced esophageal cancer, ultimately seeking to improve survival and quality of life for patients facing this daunting diagnosis.
Iza-bren, known scientifically as izalontamab brengitecan, is now recognized as a first-in-class EGFR × HER3 bispecific antibody-drug conjugate (ADC). This approval expands its clinical use, following its recent endorsement for treating recurrent or metastatic nasopharyngeal carcinoma (NPC). It solidifies Iza-bren’s reputation as a versatile treatment option with significant potential across multiple solid tumor types.
The approval came on the back of promising results from the pivotal PANKU-Esophagus01 study (BL-B01D1-305), which demonstrated that Iza-bren not only met its primary endpoints for progression-free survival (PFS) and overall survival (OS) but did so convincingly compared to traditional chemotherapy. The outcomes indicated statistically significant benefits, signaling a notable step forward in cancer treatment protocols.
For instance, the study revealed that the median overall survival with Iza-bren reached 9.8 months as opposed to just 7.2 months with standard chemotherapy (HR=0.64, 95% CI 0.49–0.83; p=0.0004). Similarly, the median progression-free survival statistics favored Iza-bren, achieving 4.2 months versus the 2.0 months seen with chemotherapy (HR=0.50; 95% CI 0.40-0.63; p<0.0001).
Furthermore, Iza-bren displayed a commendably manageable safety profile, with only 2% of patients discontinuing treatment due to adverse events. Both the incidence of interstitial lung disease (ILD) among patients receiving Iza-bren and chemotherapy remained low, with rates of all grade ILD at 1.6% and 0.4% respectively.
Dr. Yi Zhu, Chairman and CEO of Biokin, remarked, "Today's approval marks an essential achievement for Iza-bren and underscores the potential of our EGFR × HER3 bispecific ADC platform to tackle significant unmet needs in challenging cancer diagnoses." He added gratitude towards the involved patients and professionals who contributed to this milestone.
"Patients struggling with recurrent or metastatic ESCC have historically encountered limited treatment options and dismal outcomes after first-line therapies," explained Dr. Jonathan Cheng, Chief Medical Officer of SystImmune. "The impressive results from the BL-B01D1-305 study establish Iza-bren as a pivotal new option for these patients in need. Our commitment to advancing Iza-bren's global development across various tumor types remains strong."
Iza-bren is currently undergoing evaluation in several global clinical studies for various solid tumor indications, which include non-small cell lung cancer, breast cancer, and urothelial cancer, amongst others that express EGFR/HER3.
The PANKU-Esophagus01 study involved a randomized, open-label, multicenter phase 3 clinical trial assessing Iza-bren against chemotherapy for patients who had already undergone progressive disease following platinum-based chemotherapy and PD-1/PD-L1 inhibitors. A total of 497 patients were recruited across 80 study centers in China, and the encouraging findings were shared during a presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.
Esophageal squamous cell carcinoma (ESCC) is notably concerning, ranking as the seventh most diagnosed cancer globally and the sixth leading cause of cancer deaths. Particularly in China, this form of cancer accounts for around 90% of diagnosis, highlighting the urgent need for effective therapies. Even with existing treatments, many patients face progression of their disease within short timeframes, underscoring the importance of innovative solutions.
Iza-bren stands out as it uniquely targets both EGFR and HER3, known contributors to cancer cell proliferation and survival. Its dual-action mechanism effectively disrupts growth signaling, and through antibody-mediated processes, its therapeutic payload induces cancer cell death. SystImmune, located in Redmond, WA, specializes in developing advanced cancer treatments and holds several clinical and preclinical assets poised for innovation.
As forward-looking projections for Iza-bren continue to develop, the focus remains on its potential to redefine the standards of care for patients battling advanced esophageal cancer, ultimately seeking to improve survival and quality of life for patients facing this daunting diagnosis.
Topics Health）
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