Dr Besse on Results From the CARMEN-LC03 Trial in Nonsquamous NSCLC

Benjamin Besse, MD, PhD, director, clinical research, and medical oncologist at Institute Gustave Roussy, discusses findings from the phase 3 CARMEN-LC03 trial (NCT04154956), which is examining tusamitamab ravtansine in patients with advanced nonsquamous non–small cell lung cancer (NSCLC).

Tusamitamab ravtansine is a CEACAM5-targeted antibody-drug conjugate (ADC) with a DM4 payload. Findings from CARMEN-LC03 presented during the 2024 IASLC World Conference on Lung Cancer showed that patients who received the ADC (n = 194) achieved a median progression-free survival (PFS) by independent review committee of 5.4 months (95% CI, 3.7-7.0) compared with 5.9 months (95% CI, 5.5-7.4) among patients treated with docetaxel (n = 195; HR, 1.14; 95% CI, 0.86-1.51; P= .8204), missing the primary end point of the study, Besse says. However, patients in the tusamitamab ravtansine arm experienced a median overall survival (OS) of 12.8 months (95% CI, 11.8-14.2) vs 11.5 months (95% CI, 8.9-15.2) in the docetaxel arm (HR, 0.85; 95% CI, 0.64-1.11; P = .112), indicating a trend towards an OS benefit with tusamitamab ravtansine, Besse notes.

Additional findings from the study showed that CEACAM5 levels had prognostic value, Besse explains. Patients with CEACAM5 immunohistochemistry levels of at least 80% experienced a PFS (HR, 0.866; 95% CI, 0.597-1.257) and OS (HR, 0.711; 95% CI, 0.492-1.028) benefit with tusamitamab ravtansine vs docetaxel. In terms of safety, patients experienced any-grade treatment-emergent adverse effects (TEAEs) in the investigational and control arms at rates of 95.9% and 94.9%, respectively. Patients in both arms also experienced grade 3 or higher TEAEs (40.7% vs 57.6%), any-grade treatment-related adverse effects (TRAEs; 72.7% vs 85.9%), grade 3 or higher TRAEs (14.9% vs 39.5%), and treatment-emergent serious adverse effects (28.4% vs 38.4%). TEAEs leading to dose reduction (16.5% vs 36.2%), dose delay (42.8% vs 28.2%), and treatment discontinuation (7.7% vs 16.9%) were also reported.