Findings seen in patients previously treated with platinum-based chemotherapy and immunotherapy whose tumors highly expressed CEACAM5
By Lori Solomon HealthDay Reporter
FRIDAY, Sept. 13, 2024 (HealthDay News) — Tusamitamab ravtansine (tusa rav), an immunoconjugate, does not improve progression-free survival (PFS) in patients with previously treated advanced nonsquamous non-small cell lung cancer (NSCLC), according to a study presented at the International Association for the Study of Lung Cancer 2024 World Conference on Lung Cancer, held from Sept. 7 to 10 in San Diego.
Benjamin Besse, from Gustave Roussy in Paris, and colleagues randomly assigned adult participants in the CARMEN-LC03 trial (with previously treated advanced nonsquamous NSCLC with platinum-based chemotherapy and immunotherapy) to intravenously receive either tusa rav 100 mg/m2 once every two weeks (194 patients) or docetaxel 75 mg/m2 once every three weeks (177 patients). The analysis included comparison of survival among patients with CEACAM5 positivity (assessed by immunohistochemistry) of ≥2+ intensity involving ≥50 percent of tumor cells.
The researchers reported that during a median follow-up of 7.4 and 18.1 months for PFS (determined by an independent radiologic committee) and overall survival (OS), respectively, median PFS for tusa rav versus docetaxel was 5.4 versus 5.9 months (hazard ratio [HR], 1.14; 95 percent confidence interval [CI], 0.86 to 1.51; P = 0.820), while median OS (60 percent information fraction) was 12.8 versus 11.5 months (HR, 0.85; 95 percent CI, 0.64 to 1.11; P = 0.112). Objective response rates were also similar between the groups. With tusa rav, time to deterioration of disease-related symptoms/physical functioning/role functioning were numerically prolonged. Tusa rav was associated with lower numbers of grade ≥3 treatment-related adverse events (AE) and treatment-related serious AEs, as well as resulting discontinuation and dose reduction. However, dose delay was more frequent with tusa rav, mainly due to corneal events. Tusa rav was associated with incidence and severity of ocular AEs that were consistent with previous studies.
“Despite trends favoring tusa rav on interim OS and electronic patient-reported outcomes analysis, the study did not meet the dual primary end point on improving the PFS per central review, likely due to unanticipated higher median PFS and OS with docetaxel,†the authors write.
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