Izalontamab brengitecan approved for esophageal squamous cell carcinoma

Recently, the world's first approved bispecific ADC drug (EGFR×HER3 bispecific ADC), izalontamab brengitecan (iza-bren, Yizekang), was approved by the National Medical Products Administration (NMPA) for the treatment of recurrent/metastatic esophageal squamous cell carcinoma that has progressed after treatment with PD-1/PD-L1 inhibitors combined with platinum-based chemotherapy. (from NMPA)

This is the new indication for major tumor types approved within 30 days after izalontamab brengitecan was approved for nasopharyngeal cancer. izalontamab brengitecan is the world's first, new concept, and the first EGFR×HER3 bispecific ADC drug approved for marketing. This approval is expected to reshape the clinical diagnosis and treatment pattern of esophageal squamous cell carcinoma.

The approval of izalontamab brengitecan for esophageal squamous cell carcinoma indication is based on a pivotal Phase III registration clinical PANKU-Esophagus01 study conducted in China. The results of the study were reported orally at the American Society of Clinical Oncology (ASCO) annual meeting in 2026. The dual primary study endpoints of progression-free survival (PFS) and overall survival (OS) achieved positive results.

The progression-free survival time doubled, with the median PFS reaching 4.17 months in the izalontamab brengitecan group and only 1.97 months in the chemotherapy group. The risk of disease progression or death was directly reduced by 50% (HR=0.50). The 6-month PFS rate was 32.7%, which was more than twice that of chemotherapy (14.7%). The median OS of the izalontamab brengitecan group was as high as 9.79 months, compared with 7.20 months in the chemotherapy group. The patient's risk of death was reduced by 36% (HR=0.64), and the 12-month OS rate was 34.8%, which was significantly higher than that of chemotherapy (22.5%). The objective response rate (ORR) of the izalontamab brengitecan group reached 35.3%, which was nearly three times that of the chemotherapy group (13.1%). More patients achieved tumor shrinkage and gained hope for long-term survival.

Research has confirmed that izalontamab brengitecan has breakthrough efficacy advantages over traditional chemotherapy. izalontamab brengitecan can significantly prolong patient survival and improve tumor response rates, filling the gap in second-line standard treatment for esophageal squamous cell carcinoma after the progression of immunotherapy. It is expected to completely rewrite the second-line clinical path for esophageal squamous cell carcinoma and provide a new second-line standard treatment plan.

Izalontamab brengitecan is the world's first, new concept and the world's first and only EGFR×HER3 bispecific ADC drug approved for marketing independently developed by Biokin. One month ago, izalontamab brengitecan was approved by the National Medical Products Administration for the treatment of adult patients with recurrent/metastatic nasopharyngeal carcinoma who have previously failed at least two lines of systemic chemotherapy combined with PD-1/PD-L1 inhibitors.

Professor Shen Lin from Peking University Cancer Hospital pointed out that esophageal cancer is a malignant tumor with high incidence in China, of which esophageal squamous cell carcinoma accounts for more than 90%. In recent decades, treatment methods in the field have been slowly iterated, and there have been few breakthrough new drugs. Advanced metastatic esophageal squamous cell carcinoma is highly malignant and invasive, and the 5-year survival rate of patients is less than 5%. Looking around the world, patients with esophageal squamous cell carcinoma who are resistant to immunotherapy lack effective second-line treatment options. A large number of patients are faced with the dilemma of no available drugs, and survival benefits are difficult to guarantee. This research breakthrough from China is to face this global problem head-on and take the lead in delivering a breakthrough work.

It is reported that as of June 2026, Biokin is conducting more than 40 clinical trials of izalontamab brengitecan in China and the United States targeting multiple tumor types. The drug's drug marketing application (NDA) for the treatment of locally advanced or metastatic triple-negative breast cancer has also been accepted by CDE.

(Compiled by Wang Yuyan)