Bristol-Myers Squibb (BMS) and China-based Biokin's US subsidiary SystImmune announced that US health regulatory authorities granted Breakthrough Therapy designation (BTD) to izalontamab brengitecan for EGFR-mutant non-small cell lung cancer (NSCLC) after progression on tyrosine kinase inhibitors (TKIs) and platinum chemotherapy. The decision was based on data from three global studies showing promising efficacy in this heavily pretreated population. The first-in-class EGFR/HER3 bispecific antibody-drug conjugate (ADC) delivers proprietary camptothecin derivative ED04 with a drug-to-antibody ratio of 8, targeting resistance mechanisms present in approximately 50% of Asian NSCLC patients with EGFR mutations.

The designation follows BMS's USD 8.4 billion licensing deal for ex-China rights to the candidate in December 2023. The therapy holds five BTDs in China across NSCLC and nasopharyngeal carcinoma indications. With median progression-free survival (mPFS) on current EGFR inhibitors lasting approximately 18 months, izalontamab brengitecan addresses a critical unmet need for the 80% of lung cancer patients with NSCLC, particularly those with acquired resistance to targeted therapies.

According to PharmCube's NextBiopharm® database, over 200 bispecific ADC projects are under active development globally. Click here to request a free trial for NextBiopharm®.