Poseidon Pharmaceuticals announced that its internally developed 4th-generation EGFR inhibitor NVP-201 met the primary endpoint in the pivotal Phase III trial (NVP-201-301) for NSCLC with EGFR T790M/C797S mutations. Median progression-free survival (PFS) was improved by 87% versus control, with a 62% reduction in the risk of disease progression or death.
The trial enrolled 556 patients across 120 global sites. NVP-201 was generally well tolerated with no new safety signals identified. The company plans to submit an NDA to the NMPA in Q4 and is simultaneously preparing FDA registration.
"The Phase III data further validate our leadership in targeted lung cancer therapy," said the Chief Medical Officer. "For patients with T790M/C797S mutations, this represents a major therapeutic breakthrough."