Biokin Pharma’s iza-bren has recorded another significant clinical victory, meeting the primary endpoint of its Panku-Lung01 lung cancer phase 3 trial at an interim analysis.
The Chinese drugmaker disclosed the result in a securities filing, confirming a significant progression-free survival benefit for the EGFRxHER3 bispecific antibody-drug conjugate in the study.
Panku-Lung01 tested iza-bren against platinum-based chemotherapy in patients with advanced EGFR-mutated nonsquamous non-small cell lung cancer who had previously received an EGFR tyrosine kinase inhibitor.
Beyond progression-free survival, Biokin also noted a positive trend toward an overall survival improvement, adding further weight to the drug’s clinical profile.
The China phase 3 win strengthens the prospects of Bristol Myers Squibb’s global counterpart study, Izabright-Lung01, a phase 2/3 trial launched in November 2025 and expected to report results in 2028.
Previously, a phase 2 trial linked iza-bren to a median progression-free survival of 12.5 months in chemo-naive patients who had failed on a third-generation EGFR TKI, data presented at the World Conference on Lung Cancer 2025 showed.
A separate set of phase 2 results shared at WCLC 2025 demonstrated a 100% objective response rate for a combination of iza-bren and AstraZeneca’s Tagrisso in first-line EGFR-mutated NSCLC, a striking figure compared to the 77% ORR Tagrisso plus chemotherapy recorded in the phase 3 Flaura2 trial.
BMS (BMY) is now preparing the Izabright-Lung02 trial, which will test iza-bren alongside Tagrisso against either Tagrisso alone or its combination with chemotherapy in first-line EGFR-mutated NSCLC.
Panku-Lung01 marks the fourth positive phase 3 readout Biokin has reported for iza-bren since BMS paid $800 million upfront to license the drug as part of a potential $8.4 billion deal signed in late 2023.
The drug secured its first regulatory approval in June when China’s National Medical Products Administration cleared it for recurrent or metastatic nasopharyngeal carcinoma, with a second approval for previously treated esophageal squamous cell carcinoma following in July.
Chinese regulators are now reviewing iza-bren for previously treated triple-negative breast cancer, where the Panku-Breast02 trial showed the drug reduced the risk of death by 40% versus physician’s choice of chemotherapy, according to data presented at the American Society of Clinical Oncology annual meeting in June.
BMS has also moved iza-bren into global phase 3 testing in first-line TNBC through the Izabright-Breast01 trial, which is projected to read out in 2028 in PD-(L)1-ineligible patients.
In both EGFR-mutated NSCLC and TNBC, iza-bren poses a direct competitive threat to TROP2-targeted ADCs including AstraZeneca and Daiichi Sankyo’s Datroway, Gilead Sciences’ Trodelvy, and Merck and Kelun-Biotech’s sac-TMT.
Biokin is also initiating Panku-Lung05, a phase 3 China study evaluating iza-bren in combination with a PD-1xVEGF bispecific antibody for squamous NSCLC, applying further pressure on rival drug programmes.
Together, BMS and Biokin have now launched 20 phase 3 or phase 2/3 trials for iza-bren globally or in China, underscoring the scale of ambitions behind the partnership.
All of this clinical momentum comes as Biokin pursues a dual listing on the Hong Kong Stock Exchange, after withdrawing its IPO plans just days before the flotation was set to proceed last November.