Prestige Biopharma's HD204 Shows Promise as Biosimilar to Avastin in Lung Cancer Treatment

Prestige Biopharma's Phase 3 SAMSON-II study reports successful results for HD204, a proposed biosimilar to Avastin, in treating advanced non-squamous non-small cell lung cancer. The study achieved its primary endpoint of clinical equivalence and demonstrated a safety profile consistent with established treatments, paving the way for further regulatory progress.

Prestige Biopharma has announced positive results from their Phase 3 SAMSON-II study for HD204, a biosimilar to Avastin, intended for treating advanced non-squamous non-small cell lung cancer. The study involved 625 patients across 91 centers globally, establishing HD204's clinical equivalence to Avastin.

The primary endpoint of overall response rate at Week 18 showed clinical parity, with the HD204 group achieving a 48.7% response compared to 46.5% for Avastin. Both patient cohorts demonstrated comparable results in terms of progression-free and overall survival. Adverse events were consistent with previous bevacizumab safety profiles, confirming HD204's tolerability.

Prestige Biopharma is moving forward with regulatory pathways based on the study's findings. Dr. Lisa Park, CEO of Prestige Biopharma, emphasized that this success highlights biosimilarity precision and boosts biosimilar development's potential to enhance global healthcare access efficiently.

(With inputs from agencies.)