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T. Burke
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MA14 - Immunotherapy in Advanced NSCLC: Biomarkers and Costs (ID 394)
- Event: WCLC 2016
- Type: Mini Oral Session
- Track: Advanced NSCLC
- Presentations: 2
- Moderators:M. Reck, D.R. Spigel
- Coordinates: 12/06/2016, 16:00 - 17:30, Strauss 2
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MA14.05 - Implications of Implementation of a PD-L1 Biomarker-Based Strategy for Treatment of Advanced NSCLC (ID 5042)
16:30 - 16:36 | Author(s): T. Burke
- Abstract
- Presentation
Background:
The KEYNOTE-010 (KN010) clinical trial, a multi-center, worldwide, randomized Phase II/III trial of pembrolizumab 2m/kg every 3 weeks and docetaxel 75mg/m2 every 3 weeks in patients with previously treated advanced NSCLC with PD-L1 positive tumors showed a significant overall survival (OS) advantage for patients receiving pembrolizumab. We examined the improvement in prognoses for patients who elect to learn their PD-L1 biomarker results using extrapolative survival modeling.
Methods:
Partitioned survival models to project long-term outcomes were developed using data from patients enrolled in KN010, with treated patients in the pembrolizumab 2m/kg and docetaxel 75mg/m2 arms included in these analyses. As OS for docetaxel patients is not dependent on PD-L1 status, KN010 results were assumed to represent docetaxel efficacy in all patients irrespective of PD-L1 status.The model projected expected lifetime using Kaplan Meier estimates of PFS and OS from the trial with extrapolation based on parametric functions and long term registry data.
Results:
Results directly from KN010 showed for patients with TPS≥50%, median survival to be 8.2 months (6.4, 10.7) and 14.9 months (10.4, NA) for docetaxel and pembrolizumab, respectively (HR= 0.54 (0.38, 0.77)). Model-based projections show that should all patients be treated with docetaxel, expected mean lifetime is 1.0 years. For patients receiving a PD-L1 biomarker test per KN010 28.49% will be identified as PD-L1 strong positive (TPS≥50%). PD-L1 (TPS ≥50%) predicts a life expectancy with biomarker directed pembrolizumab of 2.25 years on average.
Conclusion:
Use of PD-L1 biomarker identification can significantly improve OS prognoses for patients considering pembrolizumab and docetaxel with advanced NSCLC based on both clinical trial results and model-based projections from KN010.
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MA14.10 - Relative Impact of Disease Management Costs in the Economics of Pembrolizumab in Previously Treated PD-L1 Positive Advanced NSCLC (ID 5439)
17:06 - 17:12 | Author(s): T. Burke
- Abstract
- Presentation
Background:
This study aimed to understand the impact on disease management costs beyond drug acquisition costs in the context of an economic evaluation of pembrolizumab compared with docetaxel in patients in patients with previously treated PD-L1 positive (TPS>=50%) advanced NSCLC. The analysis was conducted from a US third-party payer perspective.
Methods:
A partitioned-survival model was developed using data from patients from the KEYNOTE-010 (KN010) clinical trial. The model used KM estimates of PFS and OS from the trial for patients treated with pembrolizumab 2mg/kg and docetaxel 75kg/m[2] with extrapolation based on fitted parametric functions and long-term registry data. Costs of clinical management of advanced NSCLC along with drug acquisition/administration and adverse event management costs were included in the model. The base-case analysis used a time horizon of 20 years. Costs and health outcomes were discounted at a rate of 3% per year.
Results:
Base case results project for PD-L1 positive (TPS>=50%) patients treated with pembrolizumab a mean survival of 2.25 years. For docetaxel, a mean survival time of 1.07 years was estimated. Weekly disease management costs observed in KN010 for the progression-free state were $866 and $1,298 for pembrolizumab and docetaxel, respectively. Weekly disease management costs for the progressive disease state were $1,938 based on a US healthcare claim database. Results projected total disease management costs to be $166K per patient treated with pembrolizumab compared with $93K for docetaxel because of extended progression-free and post-progression survival with pembrolizumab. Nearly half (45%) of total expected cost differences between pembrolizumab and docetaxel are due to the incremental disease management costs. Further analyses that exclude drug treatment costs show that the additional disease management costs associated with extended progression-free and overall survival exceed $50,000 per LY gained ($61,864).
Conclusion:
Pembrolizumab improves outcomes compared to docetaxel in PD-L1 positive (TPS>=50%) pre-treated advanced NSCLC patients in the US. The improved overall survival with pembrolizumab is accompanied by the economic reality of additional non-pembrolizumab costs that represent their own substantial economic burden.
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