Dr Paz-Ares on Tusamitamab Ravtansine in CEACAM5-Positive NSCLC

Luis Paz-Ares, MD, PhD, chairman, Medical Oncology Department, Hospital Doce de Octubre; head, Lung Cancer Unit, CNIO (National Oncology Research Center); associate professor, Universidad Complutense, discusses efficacy and safety findings from the phase 2 CARMEN-LC05 trial (NCT04524689) of tusamitamab ravtansine (SAR408701) in patients with nonsquamous non–small cell lung cancer (NSCLC) with CEACAM5 expression.

CARMEN-LC05 investigated the efficacy and safety of tusamitamab ravtansine in doublet, triplet, and quadruplet combinations with pembrolizumab (Keytruda) with or without platinum-based chemotherapy and pemetrexed (Alimta) in patients with nonsquamous NSCLC with moderate to high CEACAM5 expression and any level of PD-L1 expression. In all treatment arms, patients received tusamitamab ravtansine intravenously every 3 weeks at either 150 mg/m² or 170 mg/m².

Across all dose levels, the overall response rate (ORR) was 52% (95% CI, 31.3%-72.2%), and the median duration of treatment was 24.3 weeks. Additionally, 36% of patients achieved stable disease, 12% of patients had progressive disease, and the disease control rate was 88% (95% CI, 68.8%-97.5%).

The ORRs with the doublet, triplet, and quadruplet with tusamitamab ravtansine at 150 mg/m² were 100%, 50%, and 50%, respectively. Responses were seen in patients regardless of PD-L1 or CEACAM5 expression, Paz-Ares says.

The doublet, triplet, and quadruplet regimens were tolerable, Paz-Ares notes. One dose-limiting toxicity, increased aspartate aminotransferase, was seen in a patient who received tusamitamab ravtansine at 170 mg/m² as part of the quadruplet regimen. Treatment-emergent adverse effects (TEAEs) of grade 3 or higher occurred in 68.0% of all patients, however, most were unrelated to the study regimens, Paz-Ares explains. In addition, 24.0% of all patients had corneal TEAEs, which were manageable with dose modification, Paz-Ares emphasizes. One patient in the doublet arm who received tusamitamab ravtansine at 170 mg/m² experienced a grade 3 corneal TEAE. Furthermore, 16.0% and 28.0% of all patients had pneumonitis and peripheral neuropathy, respectively, and most events were grade 1/2, Paz-Ares concludes.

Editor's Note: This summary reflects the accurate value for the median duration of the study treatment, which was 24.3 weeks, rather than 24 months, as noted in the video at 0:28.

Reference

Paz-Ares L, Nagy T, Ravoire M, et al. Safety and efficacy of tusamitamab ravtansine in comination with pembrolizumab ± chemotherapy in patients with CEACAM5-positive nonsquamous NSCLC (CARMEN-LC05 phase 2 study). Presented at: 2023 European Lung Cancer Congress; March 29-April 1, 2023; Copenhagen, Denmark. Abstract 13MO.