RELATIVITY-048 Data Highlight Potential of Triplet ICI Regimen for Advanced Melanoma
Source: OncLive , August 2024
The addition of ipilimumab (Yervoy) to nivolumab and relatlimab-rmbw (Opdualag) has generated high response rates and promising survival outcomes as a first-line treatment for patients with advanced melanoma in the phase 1/2 RELATIVITY-048 trial (NCT03459222), signifying the viability of triplet checkpoint blockade for this patient population, according to Ankit Mangla, MD. However, larger studies are needed to confirm the efficacy and safety of this approach for use in the frontline setting.
Preliminary data from RELATIVITY-048 were presented at the 2024 ASCO Annual Meeting. At a median follow-up of 49.4 months (range, 0.4-55.0), patients treated with the triplet (n = 46) achieved an overall response rate (ORR) of 59% (95% CI, 43%-73%) by investigator assessment and 52% (95% CI, 37%-61%) by blinded independent central review (BICR). The median duration of response (DOR) with the triplet was not reached (NR; 95% CI, NR-NR), nor was the median progression-free survival (PFS; 95% CI, 3.9-NR) or overall survival (OS; 95% CI, NR-NR). The 48-month PFS and OS rates were 52% (95% CI, 35%-66%) and 72% (95% CI, 56%-82%), respectively.
Additionally, higher response rates were observed in patients with cutaneous nonacral melanoma (64%) vs mucosal (33%) or acral (25%) melanoma, although long-term benefit was observed in 2 patients with the latter disease subtypes. Higher response rates were also observed in patients who had LAG3-positive (68%) vs -negative (33%) and PD-L1–positive (67%) vs –negative (59%) melanoma. No new safety signals were reported with the triplet, and the safety profile was generally consistent with that of other immunotherapy combinations.