(Lung Cancer) Is Cemiplimab Monotherapy Effective?
Medical Supporter — Information Notice
This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
On August 14, 2023, Mustafa Özgüroğlu and colleagues from Istanbul University Cerrahpaşa published the long-term follow-up results of the EMPOWER-Lung 1 Phase 3 clinical trial in the medical journal "The Lancet Oncology." The study focused on the safety and efficacy of cemiplimab monotherapy as a first-line treatment for advanced non-small cell lung cancer (NSCLC), as well as the results of adding chemotherapy upon disease progression.
The EMPOWER-Lung 1 trial was a multicenter, open-label, Phase 3 clinical trial that randomized patients with advanced NSCLC (N = 712) in a 1:1 ratio to receive either cemiplimab (350 mg every three weeks, continued until disease progression or up to 108 weeks, N = 357) or chemotherapy (N = 355). The primary endpoints were overall survival (OS) and progression-free survival (PFS). Additionally, among the randomized patients, those with PD-L1 expression ≥ 50% included 284 in the cemiplimab group and 281 in the chemotherapy group.
At a median follow-up of 35 months, the median OS (in the PD-L1 ≥ 50% group) was 26.1 months for the cemiplimab group versus 13.3 months for the chemotherapy group. The other primary endpoint, median PFS (in the PD-L1 ≥ 50% group), was 8.1 months for the cemiplimab group versus 5.3 months for the chemotherapy group. Furthermore, the PFS for patients who received cemiplimab + chemotherapy as a second-line treatment (N = 64) was 6.6 months, with a median OS of 15.1 months.
The most common Grade 3–4 adverse events were anemia: 4% (N = 15) in the cemiplimab group vs. 17% (N = 60) in the chemotherapy group; neutropenia: 1% (N = 3) in the cemiplimab group vs. 10% (N = 35) in the chemotherapy group; and pneumonia: 5% (N = 18) vs. 4% (N = 13). Treatment-related deaths due to adverse events were reported in both groups: 3% (N = 10) in the cemiplimab group and 2% (N = 7) in the chemotherapy group.
Based on the long-term follow-up results of the EMPOWER-Lung 1 trial, Mustafa Özgüroğlu and colleagues stated that at 35 months, the survival advantage of using cemiplimab as a first-line treatment for advanced NSCLC with PD-L1 ≥ 50% remained consistent with the one-year follow-up results, supporting its use as a first-line therapy. The results also suggested that adding chemotherapy upon disease progression could be a viable second-line treatment option.
Medical Supporter was formerly certified as an international medical visa guarantor by Japan's Ministry of Foreign Affairs and the Ministry of Economy, Trade and Industry (B-066).
Considering medical care in Japan? Need information and support?
We help you organize the information needed for medical travel to Japan, liaise with Japanese medical institutions, and arrange a second-opinion consultation.The first consultation is free; an advisor will help you clarify the next steps.
Figure 1
Figure 2
Figure 3
Figure 4