The first-of-its-kind ADC of CSPC was granted fast track status by FDA

On June 12, CPO301, a first-in-class antibody-drug conjugate developed by CSPC Pharmaceutical Group, was announced for the treatment of metastatic EGFR-mutated non-small cell lung cancer patients refractory to relapsed/refractory or EGFR-targeted therapies (e.g., third-generation EGFR inhibitors, including osimertinib). Fast track status was granted by the U.S. Food and Drug Administration (FDA).

Photo source: Official symbol of CSPC

Lung cancer is one of the malignant tumors with the highest morbidity and mortality in the world. It is estimated that more than 2.2 million people are diagnosed with lung cancer and more than 1.7 million people die from lung cancer every year worldwide. Activating mutations in EGFR are one of the major drivers of lung cancer and are the target of numerous approved EGFR tyrosine kinase inhibitors (Tkis), including first -, second -, and third-generation Tkis (e.g., osimertinib). Up to 25% of non-small cell lung cancer patients develop new mutations after treatment with osimertinib. There is no effective treatment except salvage chemotherapy.

Preclinical studies have shown that CPO301 inhibited the growth of human tumors with various EGFR activating mutations or high expression of wild-type EGFR in immunodeficient mice in a dose-dependent manner. CPO301 showed a strong anti-tumor effect especially in the PDX model of humanized NSCLC containing EGFR triple mutations (Exon19Del, T790M and C797S) that were resistant to the third generation EGFR-TKI osimertinib. Good safety and tolerability have been shown in preclinical toxicology and safety pharmacology studies.