Abstract No : Abstract #LBA43
Indication : Melanoma
Intervention : Spartalizumab
Company : Novartis
Technology : PD-1/PD-L1 inhibitor
532 pts were randomized to receive Sparta-DabTram (n = 267) or PBO-DabTram (n = 265). At the data cutoff (July 1, 2020), median follow-up was 27.2 mo. Baseline characteristics were balanced across tx arms. Sparta-DabTram did not significantly improve PFS vs PBO (median PFS, 16.2 mo vs 12.0 mo; HR, 0.82 [95% CI, 0.655-1.027]; P = .042). Estimated 12- and 24-mo PFS rates with Sparta-DabTram vs PBO were 58% vs 50% and 44% vs 36%, respectively. While OS was not formally tested, median OS was not reached (NR) across tx arms (HR, 0.785). The objective response rate was 69% in the Sparta-DabTram arm (complete response rate [CRR], 20%) vs 64% in the PBO arm (CRR, 18%); median duration of response was NR vs 20.7 mo, respectively. Tx-related adverse events (TRAEs) grade ≥ 3 occurred in 55% vs 33% of pts treated with Sparta-DabTram vs PBO. TRAEs leading to discontinuation of all 3 study drugs occurred in 12% vs 8% of pts, respectively.
The primary endpoint was not met. Sparta-DabTram did not significantly improve PFS vs PBO-DabTram; analyses interrogating OS benefit are ongoing. AE management was challenging and resulted in frequent dose adaptations.