(Lung Cancer) Is Cemiplimab Monotherapy Effective?

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.

Source: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(23)00329-7/fulltext?utm_campaign=shareaholic&utm_medium=twitter&utm_source=socialnetwork

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