Lifileucel, an Autologous Tumor-Infiltrating Lymphocyte Monotherapy, in Patients with Advanced Non–Small Cell Lung Cancer Resistant to Immune Checkpoint Inhibitors

Abstract

In this phase 2 multicenter study, we evaluated the efficacy and safety of li-fileucel (LN-145), an autologous tumor-infiltrating lymphocyte cell therapy, in patients with metastatic non–small cell lung cancer (mNSCLC) who had received prior immuno-therapy and progressed on their most recent therapy. The median number of prior systemic therapies was 2 (range, 1–6). Lifileucel was successfully manufactured using tumor tissue from different anatomic sites, predominantly lung. The objective response rate was 21.4% (6/28). Responses occurred in tumors with profiles typically resistant to immunotherapy, such as PD-L1–negative, low tumor mutational burden, and STK11 mutation. Two responses were ongoing at the time of data cutoff, including one complete metabolic response in a PD-L1−negative tumor. Adverse events were generally as expected and manageable. Two patients died of treatment-emergent adverse events: cardiac failure and multiple organ failure. Lifileucel is a potential treatment option for patients with mNSCLC refractory to prior therapy.