KEY TAKEAWAYS
- The CARMEN-LC05 study evaluated the efficacy and safety of Tusamitamab Ravtansine combined with SoC regimens in pts with advanced/metastatic NSQ NSCLC.
- The study comprised three treatment arms: pembro [T2]; with pembro + pCT [T3]; and with pembro + pCT + pemetrexed [T4].
- Tusamitamab Ravtansine with SoC showed encouraging antitumor activity across all treatment arms with a favorable safety profile.
The CARMEN-LC05 study comprised three treatment arms: pembrolizumab (pembro)[T2]; with pembro + platinum-based chemotherapy (pCT) [T3]; and with pembro + pCT + pemetrexed [T4]. Patients (pts) were selected based on their carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) intensity of ≥2+ in ≥1% of tumor cells by immunohistochemistry. Tusamitamab ravtansine (tusa rav) was given IV Q3W at 150 or 170 mg/m2 in each treatment arm.
Based on data as of November 28, 2022, 25 pts received treatment for a median of 21 weeks, with a range of 3-86 weeks, and 12 pts (48%) are still undergoing treatment. One case of dose-limiting toxicity involved increased aspartate aminotransferase in the T4 tusa rav 170mg/m2 group.
The most frequent treatment-emergent adverse events were nausea (44%), diarrhea (36%), and asthenia (32%). Grade ≥3 events occurred in 68% of patients, while Grade 5 events occurred in 16% during treatment, unrelated to tusa rav. Corneal TEAEs of any grade were observed in 24% of patients, with only one case of keratitis being Grade ≥3 in the T2 tusa rav 170mg/m2 group. The objective response rate (ORR) and disease control rate (DCR) for all patients were 40% and 88%, respectively.
The combination treatment of Tusa rav and SoC has shown promising results in effectively treating tumors, with all treatment arms exhibiting safe profiles. The T4 arm also showed positive results without any new safety concerns during the evaluation process.
Source: https://www.jto.org/article/S1556-0864(23)00267-8/fulltext
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT04524689
Isambert, N., Nagy, T., Ravoire, M., Rodriguez-Abreu, D., Gonzalez-Larriba, J.L., Huang, C.H., Paz-Ares, L., Roubec, J., Rey, F., Robinet, G., Onn, A., Shamai, S., Bensfia, S., Soufflet, C., Chevance, A., Veillon, R. Journal of Thoracic Oncology (2023)
