Dr Hiltermann on ARTEMIDE-01 Data With Rilvegostomig in Metastatic NSCLC

T. Jeroen N. Hiltermann, MD, faculty of medical sciences, University of Groningen, discusses findings from the phase 1/2 ARTEMIDE-01 trial (NCT04995523), which is the first-in-human study of the anti–PD-1/TIGIT bispecific antibody rilvegostomig for the treatment of patients with metastatic non–small cell lung cancer with a PD-L1 tumor proportion score of at least 1% who have not received a prior checkpoint inhibitor.

Data from ARTEMIDE-01 presented during the 2024 IASLC World Conference on Lung Cancer demonstrated that patients who received rilvegostomig 750 mg every 3 weeks with a PD-L1 tumor proportion score (TPS) between 1% and 49% (n = 31) achieved a confirmed objective response rate (ORR) of 29% (95% CI, 14.2%-48.0%). Patients treated at this dose level with a PD-L1 TPS of at least 50% (n = 34) experienced a confirmed ORR of 61.8% (95% CI, 43.6%-77.8%), Hiltermann notes. At the time of the presentation, patients were continuing treatment at rates of 38.7% and 70.6%, respectively.

The median progression-free survival (PFS) in the group with a PD-L1 TPS between 1% and 49% was 6.0 months (95% CI, 2.7-8.4) and the median duration of response (DOR) was 6.4 months (95% CI, 4.2-not calculable [NC]). In the group of patients with a PD-L1 TPS of at least 50%, the median PFS was 10.2 months (95% CI, 6.3-NC) and the median DOR was 10.3 months (95% CI, 8.2-NC); these data were immature at the time of the presentation, Hiltermann says.

The safety profile of rilvegostomig was tolerable, Hiltermann continues. Most adverse effects (AEs) were low grade, manageable, and reversible, with no clear differences being reported between the 750 mg and 1500 mg dose levels. No grade 4 or 5 treatment-related AEs were observed, 2.1% of patients experienced grade 3 or higher immune-mediated AEs, and 4.2% of patients discontinued rilvegostomig due to treatment-related AEs.