Randomized trial evaluates clinical equivalence of BCD-201 and reference pembrolizumab in advanced melanoma, suggesting potential for expanded access to therapy.
Key Points
This study aims to evaluate the clinical equivalence of BCD-201, a biosimilar of pembrolizumab, compared to reference pembrolizumab in patients with advanced melanoma.
International, multicenter, randomized, double-blind phase III trial
479 adult patients with unresectable or metastatic melanoma enrolled
Patients received either BCD-201 or reference pembrolizumab every 3 weeks for 24 weeks, with stratification by ECOG, PD-L1 expression, and disease stage.
At week 24, objective response rates were 33.3% for BCD-201 and 32.7% for reference pembrolizumab, with a difference of 0.7% (95% CI −7.7 to 9.1), within equivalence margins.
Progression-free survival rates were 51.9% for BCD-201 and 50.5% for reference pembrolizumab.
Overall survival rates were 90.2% for BCD-201 and 89.3% for reference pembrolizumab.