Biokin Pharma reported positive results from the phase 3 Panku-Lung01 study of iza-bren, its EGFRxHER3 bispecific antibody-drug conjugate (ADC) partnered with Bristol Myers Squibb (BMS). According to a securities filing released Tuesday, the trial achieved its primary endpoint during an interim analysis by demonstrating a statistically significant progression-free survival (PFS) benefit.
The study enrolled patients in China with advanced EGFR-mutated nonsquamous non-small cell lung cancer (NSCLC) whose disease had progressed following treatment with an EGFR tyrosine kinase inhibitor (TKI). Participants received either iza-bren or platinum-based chemotherapy. Biokin also reported a positive trend toward improved overall survival.
Biokin said, “The study in China tested the EGFRxHER3 bispecific ADC against platinum-based chemotherapy in patients with advanced EGFR-mutated nonsquamous non-small cell lung cancer following treatment with an EGFR tyrosine kinase inhibitor (TKI).”
Phase 3 Lung Cancer Data and Ongoing Global Studies
The phase 3 result in China comes as Bristol Myers Squibb continues development of the global phase 2/3 Izabright-Lung01 study, which was launched in November 2025 and is expected to read out in 2028. In both studies, patients are required to have progressed on a third-generation EGFR TKI.
Earlier data presented at the World Conference on Lung Cancer 2025 showed that, in a subgroup of chemotherapy-naïve patients who had failed treatment with a third-generation EGFR TKI, iza-bren was associated with a median PFS of 12.5 months in a phase 2 trial.
Bristol Myers Squibb is also preparing the phase 3 Izabright-Lung02 study in first-line EGFR-mutated NSCLC. The trial will evaluate iza-bren in combination with AstraZeneca’s Tagrisso against either Tagrisso alone or Tagrisso combined with chemotherapy.
Combination Therapy Results Support Further Development
Additional phase 2 results presented at WCLC 2025 showed a 100% objective response rate for the combination of iza-bren and Tagrisso in first-line EGFR-mutated NSCLC. After a median follow-up of 12.8 months, the median duration of response and median PFS had not yet been reached.
Biokin is also initiating the phase 3 Panku-Lung05 study in China. The trial will evaluate iza-bren in combination with a PD-1xVEGF bispecific antibody in patients with squamous NSCLC.
Approvals and Additional Indications Under Review
Panku-Lung01 represents the fourth positive phase 3 study reported by Biokin for iza-bren. The drug received its first regulatory approval in June from China’s National Medical Products Administration for recurrent or metastatic nasopharyngeal carcinoma following previous treatment with PD-1/L1 therapy and chemotherapy. The approval was based on results from the Panku-NPC01 trial.
In July, the drug received a second approval in China for previously treated esophageal squamous cell carcinoma following positive PFS and overall survival results from the Panku-Esophagus01 study.
Chinese regulators are also reviewing iza-bren for previously treated triple-negative breast cancer (TNBC). Data presented at the American Society of Clinical Oncology annual meeting in June showed that, in the Panku-Breast02 trial, the drug reduced the risk of death by 40% compared with physician’s choice of chemotherapy.
Bristol Myers Squibb has also advanced iza-bren into global phase 3 testing in first-line TNBC through the Izabright-Breast01 study in PD-(L)1-ineligible patients, with results expected in 2028.
According to Biokin, the company and Bristol Myers Squibb have launched 20 phase 3 or phase 2/3 studies of iza-bren globally or in China. The continued development of the drug comes as Biokin pursues a double listing on the Hong Kong Stock Exchange after withdrawing a planned initial public offering shortly before its scheduled launch in November last year.
Biokin has reported that its investigational drug iza-bren met the primary endpoint in the Phase 3 Panku-Lung01 trial. The study showed a statistically significant progression-free survival benefit compared with platinum-based chemotherapy in patients with advanced EGFR-mutated nonsquamous non-small cell lung cancer.
For Biokin, the result represents another important clinical milestone for iza-bren and expands the drug’s growing Phase 3 record across multiple cancer types.
Biokin Advances Iza-Bren in Lung Cancer
The Panku-Lung01 study evaluated Biokin’s iza-bren in patients whose disease had progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor. The trial compared iza-bren with platinum-based chemotherapy.
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