Biokin Pharma’s iza-bren, a first-in-class antibody-drug conjugate partnered with Bristol Myers Squibb, has posted another positive phase 3 readout.
The Panku-Lung01 lung cancer trial met its primary endpoint at an interim analysis, showing a significant progression-free survival benefit for iza-bren, Biokin said Tuesday in a securities filing (Chinese, PDF). 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).
A positive trend toward an overall survival improvement was also observed, according to Biokin.
The phase 3 win from China boosts the chance of success for BMS’ global counterpart trial, Izabright-Lung01, a phase 2/3 trial launched in November 2025 and expected to read out in 2028. In both studies, patients are required to have progressed on a third-generation EGFR TKI.
Previously, in a subgroup of chemo-naïve patients who had failed on a third-generation EGFR TKI, a phase 2 trial linked iza-bren to a median PFS of 12.5 months, according to data presented at the World Conference on Lung Cancer 2025.
The New Jersey pharma is preparing to launch an ambitious phase 3 trial, Izabright-Lung02, in first-line EGFR-mutated NSCLC. The study, the fourth global phase 3 that BMS has outlined for iza-bren, will test the bispecific ADC in combination with AstraZeneca’s Tagrisso against either Tagrisso alone or its combination with chemo.
Another set of phase 2 results shared at WCLC 2025 showed a 100% objective response rate for a 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 PFS had not been reached at that time. For reference, in the phase 3 Flaura2 trial, Tagrisso plus chemo registered an ORR of 77% in the same treatment setting.
Iza-bren has been on a winning streak since BMS paid $800 million upfront to license the drug in a potential $8.4 billion deal signed in late 2023.
For Biokin, Panku-Lung01 marks the fourth positive phase 3 trial the Chinese drugmaker has reported for iza-bren. The drug got its first regulatory approval in June when China’s National Medical Products Administration cleared it for recurrent or metastatic nasopharyngeal carcinoma following previous treatment with PD-1/L1 and chemo based on data from the Panku-NPC01 trial.
The drug quickly added previously treated esophageal squamous cell carcinoma to its China label in July, thanks to positive PFS and OS results from the Panku-Esophagus01 study.
In what could be iza-bren’s third indication, Chinese regulators are reviewing the drug for previously treated triple-negative breast cancer (TNBC). In the Panku-Breast02 trial, iza-bren significantly 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, taking a step further, has moved iza-bren into global phase 3 testing in first-line TNBC, as the Izabright-Breast01 trial in PD-(L)1-ineligible patients is projected to read out in 2028.
Together, BMS and Biokin have launched 20 phase 3 or phase 2/3 trials for iza-bren globally or in China, according to Biokin.
In both EGFR-mutated NSCLC and TNBC, iza-bren poses a threat to TROP2-targeted ADCs, including AstraZeneca and Daiichi Sankyo’s Datroway, Gilead Sciences’ Trodelvy and Merck & Co. and Kelun-Biotech’s sac-TMT.
Getting ever more ambitious and potentially adding more pressure on TROP2 ADCs, Biokin is also initiating a phase 3 trial in first-line NSCLC. The China study, dubbed Panku-Lung05, will evaluate iza-bren in combination with a PD-1xVEGF bispecific antibody—one of the hottest frontiers in oncology drug development—for squamous NSCLC.
All the iza-bren advancement comes as Biokin is gunning for a double listing on the Hong Kong Stock Exchange after pulling the plug days before a planned IPO last November.