What drugs are used for lung cancer with high PD-L1 expression? Libtayo combined with chemotherapy significantly improves overall survival.
In all cases of non-small cell lung cancer (NSCLC), about 25%-30% are high expression of PD-L1 (TPS≥50%). In recent years, although immunotherapy has changed the treatment method of patients with advanced NSCLC, it is still necessary to optimize the treatment of patients with high expression of PD-L1. The latest research results show that PD-1 therapy Libtayo combined with chemotherapy can significantly improve the overall survival rate of patients.
Libtayo drug introduction
Product name: Libtayo
Drug name: Cemiplimab
Manufacturer: Sanofi, Regeneron
Libtayo (Cemiplimab) is a whole-person monoclonal antibody that targets the immune checkpoint receptor PD-1 on T cells. By binding to PD-1, Libtayo has been shown to prevent cancer cells from inhibiting the activation of T cells through the PD-1 pathway. In the United States, the European Union and other countries, Libtayo has been approved for the treatment of adult patients with metastatic or locally advanced skin squamous cell carcinoma (CSCC) who are not suitable for radical surgery or radical radiotherapy. In addition, Libtayo is the first immunotherapy approved for the treatment of basal cell carcinoma (BCC).
Libtayo International Research Data
The randomized, multicenter phase 3 trial EMPOWER-Lung 3 investigated first-line combination therapy of Libtayo and platinum-based doublet chemotherapy versus platinum-based doublet chemotherapy alone in squamous or non-squamous advanced NSCLC, regardless of PD-L expression. Specifically, the trial included 466 patients who were ALK, EGFR, and ROS1 mutation-negative, had previously untreated metastatic NSCLC (stage IV) or locally advanced NSCLC (stage IIIB/C), and were not definitive candidates for chemoradiotherapy. The 466 patients enrolled were randomized 2:1 to receive either Libtayo in combination or doublet chemotherapy. At enrollment, 30% of tumors expressed <1% PD-L1, 38% expressed 1% to 49% PD-L1, and 33% expressed ≥50% PD-L1.
The median age of the patients was 63.0 years; 57.1% had non-squamous NSCLC, and 85.2% had stage IV disease. Patients were randomized 2:1 to receive Libtayo 350 mg (n=312) or placebo (n=154) intravenously every three weeks for 108 weeks, followed by four cycles of platinum-based doublet chemotherapy every three weeks. The co-primary endpoints were overall survival (OS) and progression-free survival, and key secondary endpoints included objective response rate and best overall response.
The results showed that: (1) The median OS of Libtayo combined chemotherapy was 21.9 months, while that of chemotherapy and placebo was 13.0 months, and the risk ratio (HR) was 0.71 (95% CI, 0.53-0.93;P=. 014).
(2) The median PFS of Libtayo combined with chemotherapy was 8.2 months, while the median PFS of chemotherapy and placebo was 5.0 months, with an HR of 0.56 (95% CI: 0.44 to 0.70; P < .0001), which reduced the risk of disease progression by 44%.
(3) Compared with chemotherapy and placebo, Libtayo combined chemotherapy has a higher objective remission rate (43.3% vs. 22.7%).
(4) The median duration of remission (DOR) of Libtayo combined chemotherapy was 16 months, while chemotherapy was 7 months.
Regarding safety, no new safety signals for Libtayo were identified. The median duration of exposure for Libtayo combination therapy was 38 weeks (n=312), and for chemotherapy, it was 21 weeks (n=153). Adverse events (AEs) of any grade occurred in 96% of patients receiving Libtayo combination therapy and 94% of patients receiving chemotherapy alone, with 19% and 0% of these events being immune-mediated, respectively. For the Libtayo combination therapy group, the most common AEs were anemia, alopecia, and nausea; grade ≥3 AEs occurring in ≥5% of patients were anemia and neutropenia. Treatment was discontinued due to AEs in 5% of patients receiving Libtayo combination therapy and 3% of patients receiving chemotherapy.
Reminder: The results of the study show that Libtayo monotherapy significantly improved the total survival and non-progressive survival of patients with advanced NSCLC with high PD-L1 expression. The approval of Libtayo also provides a new treatment plan for this patient population.
