China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its best-in-class antibody drug conjugate (ADC), CPO301, has received fast-track status for the treatment of recurrent/refractory (R/R) or EGFR targeted therapy ineffective metastatic EGFR mutant non-small cell lung cancer (NSCLC).
Preclinical Efficacy and Safety of CPO301
Preclinical studies have demonstrated that CPO301 effectively inhibits the growth of human tumors with various EGFR-activated mutations or wild-type EGFR overexpression models in immunocompromised mice, showing a dose-dependent response. Notably, CPO301 has shown particularly strong antitumor effects in human-derived tissue xenotransplantation (PDX) models of humanized non-small cell lung cancer containing EGFR triple mutations (Exon19Del, T790M, and C797S), which are known to confer resistance to third-generation EGFR tyrosine kinase inhibitors (TKIs) such as osimertinib. In addition to its efficacy, CPO301 has also demonstrated good safety and tolerability profiles in preclinical toxicology and safety pharmacology studies.
Implications of Fast-Track Designation for CPO301
The fast-track status granted to CPO301 by regulatory authorities highlights the potential significance of this ADC in addressing the unmet needs of patients with R/R EGFR mutated NSCLC. This designation is expected to expedite the development and review process, potentially bringing this promising therapy to market more rapidly and improving treatment outcomes for patients with this aggressive form of lung cancer.-Fineline Info & Tech
