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R-Pharm's Pembrolizumab Biosimilar, Arfleyda, Shows Non-Inferiority in Phase III Melanoma Trial

• R-Pharm's biosimilar Arfleyda, a pembrolizumab equivalent, demonstrated non-inferior efficacy and safety compared to the original drug in a Phase III clinical trial. • The trial included over 250 adult patients with skin melanoma, randomized to receive either Arfleyda or the original pembrolizumab. • Arfleyda achieved an objective response rate of 28.35%, compared to 24.56% in the original pembrolizumab group, meeting the non-inferiority criteria. • The biosimilar development process included rigorous in vitro tests and animal studies, confirming Arfleyda's equivalence to pembrolizumab at each stage.

R-Pharm's biosimilar of pembrolizumab, named Arfleyda, has shown non-inferior efficacy and safety compared to the original drug in a Phase III clinical trial. The results were presented at the XXVIII Russian Oncology Congress by Igor Samoylenko, a senior researcher at the Blokhin National Medical Research Center of Oncology.

Phase III Trial Results

The Phase III study involved over 250 adult patients diagnosed with skin melanoma. Patients were randomly assigned to receive either Arfleyda or the original pembrolizumab. The primary endpoint was objective response rate (ORR).
The results indicated that Arfleyda achieved an ORR of 28.35%, while the original pembrolizumab showed an ORR of 24.56%. To confirm non-inferiority, a 95% confidence interval for the relative risk indicator was calculated. The lower limit of the confidence interval was 0.755, exceeding the pre-defined non-inferiority threshold of 0.644.

Biosimilar Development

The development of Arfleyda involved comprehensive testing, starting with in vitro studies and progressing to animal studies. These studies were designed to demonstrate the equivalence of R-Pharm's biosimilar to pembrolizumab at each stage of development. The data presented at the congress highlighted the rigorous process undertaken to ensure the biosimilar's similarity in terms of efficacy and safety.
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Reference News

[1]
R-Pharm reported phase III trial results of pembrolizumab - GxP News
gxpnews.net · Nov 21, 2024

At the XXVIII Russian Oncology Congress, a phase III trial of 'Arfleyda', a biosimilar to pembrolizumab, showed equivale...

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