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T. Burke
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P1.01 - Advanced NSCLC (ID 757)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P1.01-050 - Cost-Effectiveness of PDL1 Based Test-And-Treat Strategy with Pembrolizumab as the 1st Line Treatment for NSCLC in Hong Kong (ID 8013)
09:30 - 09:30 | Author(s): T. Burke
- Abstract
Background:
Pembrolizumab, a monoclonal antibody against PD-1, is approved by several regulatory agencies for first line treatment in metastatic NSCLC with a PD-L1 tumour proportion score (TPS) ≥50%. An economic model was developed to evaluate the cost-effectiveness of employing a biomarker (PD-L1) test-and-treat strategy (BTS), in which patients with TPS ≥50% are treated with pembrolizumab, and other patients receive standard-of-care (SoC) cytotoxic chemotherapies versus a non-BTS strategy with all patients receiving SoC. Patients with activating EGFR mutations and ALK translocations were excluded from the analysis.
Method:
The model was built with partitioned survival approach to estimate the incremental cost effectiveness ratio (ICER) expressed as cost per quality-adjusted life-year (QALY) gained. The clinical efficacy, utility and safety data used in this model were derived from the KN024 trial. The base case comparator in the model included five different platinum-based chemotherapy regimens used as SoC for advanced NSCLC in Hong Kong. The base-case time horizon for the model was 10 years with costs and health outcomes discounted at a rate of 3% per year. Utilities for the base case were based on utility data collected in KN024. Costs and disutility associated with grade 3-5 adverse effects of incidence rate 5%, including anaemia, neutropenia, pneumonia, thrombocytopenia and pneumonitis were considered in the model. Treatment was continued until disease progression or maximum 2 years for pembrolizumab. Local drug acquisition costs, PD-L1 testing costs, drug administration costs, disease management costs were applied. A series of sensitivity analyses were conducted to evaluate the uncertainty of cost-effectiveness results.
Result:
The BTS approach was projected to increase QALY by 0.29 with an additional total cost of HK$ 249,077 (USD 31,933) compared to non-BTS approach resulting in an incremental cost-effectiveness ratio (ICER) of HK$ 865,189 (USD 110,922) per QALY gained. This is lower than the World Health Organization (WHO) cost-effectiveness threshold of 3 times 2016 GDP per capita of Hong Kong, HK$ 1,017,819 (USD 130,490). Probabilistic sensitivity analysis showed 94.6% probability that the ICERs would be below this threshold. In a scenario analysis, a lower ICER of HK$ 859,284 (USD 110,165) was shown in comparison of pembrolizumab versus SoC among patients with TPS ≥50%.
Conclusion:
A BTS to identify a subset of NSCLC patients with PD-L1 TPS ≥50% to be treated with pembrolizumab in the first line setting can be considered cost-effective in Hong Kong.
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P2.04 - Clinical Design, Statistics and Clinical Trials (ID 705)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Clinical Design, Statistics and Clinical Trials
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.04-014 - Computing the Impact of Immunotherapy on NSCLC Landscape: The Advanced Non-Small Cell Lung Cancer Holistic Registry (ANCHoR) (ID 9505)
09:30 - 09:30 | Author(s): T. Burke
- Abstract
Background:
Anti-PD-1 and anti-PD-L1 antibodies including pembrolizumab, nivolumab and atezolizumab have entered clinical practice in the management of metastatic NSCLC as monotherapy and immunotherapy-based combinations. We have established a real-world Advanced Non-Small Cell Lung Cancer Holistic Registry (ANCHoR) to understand how the emergence of immunotherapy impacts choice of treatment, clinical outcomes, and patient reported outcomes (PROs) in the different histo-molecular subtypes of metastatic NSCLC. The objectives of ANCHoR are to determine the treatment choice and treatment sequence by PD-L1 status in the various histo-molecular categories of NSCLC and to understand the impact of such treatment choice on response rates, progression-free survival (PFS), and overall survival (OS). Additionally we will measure the impact the treatment choices have on the PROs by utilizing the validated instruments, EuroQol-5D version 5L (EQ-5D-5L) and MD Anderson Symptom Inventory module specific to lung cancer (MDASI-LC).
Method:
The study will enroll patients with metastatic NSCLC diagnoses who are treated at MD Anderson Cancer Center (MDA) between January 1, 2017 and December 31, 2020. The study period will end on June 30, 2021 to allow a minimum of six months of follow-up. Trained abstractors will collect demographic, diagnostic, clinical, molecular (biomarker and PD-L1), treatment (regimens utilized in sequence and reason for discontinuation), response and survival (including PFS and OS), health care resource utilization and PRO (EQ-5D-5L and MDASI-LC) information that will be integrated in a comprehensive database. Information from the MDA electronic medical record will be extracted and populated in the GEnomic Marker-guided therapy INItiative (GEMINI) database and the PRO database which are linked. EQ-5D-5L followed by MDASI-LC will be completed directly by the patients and these will be automatically populated in the web-based PRO database at treatment initiation, at the time of response assessments and when switching lines of therapy.
Result:
Interim analysis will be conducted every six months to measure the impact of immunotherapy over time. Study results will be presented using descriptive statistics for continuous variables (mean, standard deviation, median, and interquartile range), categorical variables (frequency and proportions), and time-to-event variables (Kaplan-Meier). Regression models will be used for estimating the relationship between dependent variable and one or more predictors. Cox proportional hazards model will be used to estimate hazard ratios for time-to-event outcomes.
Conclusion:
The ANCHoR study is the first comprehensive registry of its kind that will enable the quantification of the changing impact of immunotherapy on the real-world NSCLC treatment landscape.
