Biokin：BL-B01D1 has initiated its 13th Phase III clinical trial.
On June 11, the Clinicaltrials.gov official website showed that Biokin Pharmaceutical has registered a Phase III clinical trial, PANKU-Lung08, to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib versus osimertinib (a third-generation EGFR-TKI) monotherapy in patients with EGFR-mutant non-small cell lung cancer (NSCLC).
This is a registrational Phase III, randomized, open-label, multicenter study (NCT07640789) to be conducted in China, enrolling patients with locally advanced, unresectable EGFR-mutant NSCLC who have not progressed after platinum-based chemoradiotherapy.
BL-B01D1 (iza-bren) is a first-in-class EGFR×HER3 bispecific ADC developed by Biokin Pharmaceutical. In December 2023, BMS entered into a collaboration with Biokin Pharmaceutical totaling up to $8.4 billion, gaining rights to co-develop BL-B01D1 with Biokin’s subsidiary SystImmune outside of China.
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