Wungki Park

Cost-effectiveness of Osimertinib in the First-Line Treatment of Patients With EGFR-Mutated Advanced Non–Small Cell Lung Cancer

Importance The survival of patients with advanced non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) gene mutations has improved substantially in the last decade with the development of targeted tyrosine kinase inhibitors (TKIs). Osimertinib, a third-generation TKI that is approved by the US Food and Drug Administration for the treatment of patients who develop EGFR T790M mutations, has recently shown improved clinical outcomes compared with gefitinib and erlotinib for treatment-naive patients. Objective The aim of this study was to assess the cost-effectiveness of osimertinib for the first-line treatment of patients with EGFR-mutated NSCLC. Design, Setting, and Participants For this cost-effectiveness analysis, we extracted individual patient data from the FLAURA randomized clinical trial and used findings of our earlier meta-analysis to develop a decision-analytic model and determine the cost-effectiveness of osimertinib (AZD9291) compared with first- and second-generation EGFR-TKIs over a 10-year time horizon. All direct costs were based on US and Brazilian payer perspectives. Main Outcomes and Measures The main outcome of this study was the incremental cost-effectiveness ratio (ICER) expressed as cost per quality-adjusted life-year (QALY) gained by using osimertinib compared with first- or second-generation EGFR-TKIs in previously untreated EGFR-mutated NSCLC. Results In the base case using the data as reported in the FLAURA trial, the incremental QALY for osimertinib was 0.594 compared with the first- and second-generation EGFR-TKIs. In the United States, the osimertinib ICERs were

Developing a Predictive Model for Clinical Outcomes of Advanced Non-Small Cell Lung Cancer Patients Treated With Nivolumab

226 527 vs erlotinib,

Complete response to ipilimumab and nivolumab therapy in a patient with extensive extrapulmonary high-grade small cell carcinoma of the pancreas and HIV infection

231 123 vs gefitinib, and

Autoimmune haemolytic anaemia in a patient with advanced lung adenocarcinoma and chronic lymphocytic leukaemia receiving nivolumab and intravenous immunoglobulin

219 874 vs afatinib. In Brazil, the ICERs were

The Concept of Biosimilars: From Characterization to Evolution-A Narrative Review

162 329,

Long-term survival based on pathologic response to neoadjuvant therapy in esophageal cancer

180 804, and

P3.02c-081 Complete Blood Count Parameters as Predictive Factors in Patients with Advanced Non-Small Cell Lung Cancer Treated with Nivolumab: Topic: IT Biomarkers

175 432, respectively. The overall survival (95% CI) reported in the FLAURA trial (hazard ratio, 0.63; 95% CI, 0.45-0.88) had the strongest association with the ICER (ranging from

P1.04-19 Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios Predict Survival After Immunotherapy in Non-Small Cell Lung Cancer

84 342 to

P2.01-82 Neutrophil-to-Lymphocyte Ratio Complements the Prognostic Ability of PD-L1 in Non-Small Cell Lung Cancer Treated with PD-1/PD-L1 Inhibitors

859 771). Osimertinib price adjustments to the FLAURA trial data improved cost-effectiveness. For example, a discount of 10% on osimertinib acquisition cost was associated with a 20% decreased ICER compared with the base case ICER, and a discount of 20% on osimertinib acquisition cost was associated with a 40% decreased ICER compared with the base case ICER. Conclusions and Relevance At current costs, by World Health Organization cost-effectiveness threshold criteria, osimertinib is not cost-effective for first-line therapy of EGFR-mutated NSCLC in either the United States or Brazil.

Predicting outcomes of advanced non-small cell lung cancer patients treated with PD-1/PDL-1 inhibitors: Independent international validation of the iSEND model.

Micro‐Abstract A single biomarker cannot account for the heterogeneous tumor biology and immune interplay in patients with advanced non–small cell lung cancer who receive programmed death inhibitor. This article reports our initial model development that incorporates differential weightings of clinical and hematologic variables for a future algorithm. The immunotherapy, Sex, Eastern Cooperative Oncology Group performance status, Neutrophil‐to‐lymphocyte ratio (NLR), and Delta NLR are incorporated into the model that categorizes patients into different risk groups and significantly discriminates each groups clinical outcome. Introduction Despite significant improvement of clinical outcomes of advanced non–small‐cell lung cancer (NSCLC) patients treated with immunotherapy, our knowledge of optimal biomarkers is still limited. Patients and Methods We retrospectively evaluated 159 advanced NSCLC patients in our institution treated with nivolumab after disease progression during platinum‐based chemotherapy. We correlated several variables with progression‐free survival (PFS) to develop the immunotherapy, Sex, Eastern Cooperative Oncology Group performance status, Neutrophil‐to‐lymphocyte ratio (NLR), and Delta NLR (iSEND) model. We categorized patients into iSEND good, intermediate, and poor risk groups and evaluated their clinical outcomes. Performance of iSEND at 3, 6, 9, and 12 months was evaluated according to receiver operating characteristic (ROC) curves and internally validated using bootstrapping. The association of iSEND risk groups with clinical benefit was evaluated using logistic regression. Results Median follow‐up was 11.5 months (95% confidence interval [CI], 9.4‐13.1). There were 50 deaths and 43 with disease progression without death. PFS rates at 3, 6, 9, and 12 months were 78.4%, 63.7%, 55.3%, and 52.2% in iSEND good; 79.4%, 44.3%, 25.9%, and 19.2% in iSEND intermediate; and 65%, 25.9%, 22.8%, and 17.8% in iSEND poor. Time‐dependent area under ROC curves of iSEND for PFS at 3, 6, 9, and 12 months were 0.718, 0.74, 0.746, and 0.774. The iSEND poor group was significantly associated with progressive disease at 12 ± 2 weeks (odds ratio, 9.59; 95% CI, 3.8‐26.9; P < .0001). Conclusion The iSEND model is an algorithmic model that can characterize clinical outcomes of advanced NSCLC patients receiving nivolumab into good, intermediate, or poor risk groups and might be useful as a predictive model if validated independently.