IMMUNOTHERAPY IN THE PUBLIC HEALTH SYSTEM: EXPERIENCE OF THE FIRST BRAZILIAN PROGRAM TO TREAT NON-SMALL-CELL LUNG CANCER PATIENTS WITH PEMBROLIZUMAB

Background: Immunotherapy (IO) with anti-PD(L)-1 antibodies have become an integral of the current management of advanced non-small cell lung cancer (aNSCLC). Patients whose tumors have high PD-L1 expression (Tumor Proportion Score – TPS ≥50%) are most likely to respond to these drugs, both as monotherapy or in combination with chemotherapy. However, despite being standard of care in this scenario, IO is not yet available for Brazilian patients in the public health system (SUS). Aim: The objective of this study was to assess the effectiveness of pembrolizumab in patients with aNSCLC included in the first Brazilian program to give access to IO in the SUS. Methods: This is a retrospective analysis of patients included in a drug access program stablished through an agreement between the government of the state of São Paulo, a pharmaceutical company and an oncological hospital. The agreement, established in August 2018, intended to allow pembrolizumab to be administered to aNSCLC patients with high PD-L1 expressing tumors. Up to three patients per month could be included. The program opened for recruitment in September 2018 but was closed in December 2018 following changes in government. Epidemiological characteristics and treatment pattern data were recovered from medical records. Kaplan-Meier method was used for survival analysis and descriptive statistics were used for epidemiological and clinical data analysis. The cut-off date for analysis was December 31, 2020. The study was approved by the local IRB (CAAE 87212918.5.3001.5432). Results: Twelve patients were included in the study. Median follow-up was 25.2 months. Fifty-eight percent of patients were male, 16.7% never smoker, 50% had squamous cell carcinoma, 58.3% received pembrolizumab as first line therapy and 50% were treated with chemotherapy plus pembrolizumab. TPS ranged from 55% to 90%. The ORR was 50% and the DCR was 83.3%. The median overall survival was not reached and the survival rate at 2 years was 58.3%. Conclusions: This is the first program created to guarantee access to immunotherapy in the public health scenario in Brazil. Despite the small number of patients included, the results are similar to those observed in the pivotal randomized clinical trials. These data support the feasibility of administering IO for aNSCLC patients in the SUS and the selection of high PD-L1 expressors improves the cost-effectiveness ratio, making it more attractive in the public health scenario.