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Poster display session

3049 - Costs of Dacomitinib versus Placebo in Pretreated Unselected Patients (Pts) with Advanced NSCLC: CCTG BR.26

Date

10 Sep 2017

Session

Poster display session

Topics

Cytotoxic Therapy;  Cancers in Adolescents and Young Adults (AYA);  Bioethical Principles and GCP;  Non-Small Cell Lung Cancer

Presenters

Safiya Karim

Citation

Annals of Oncology (2017) 28 (suppl_5): v395-v402. 10.1093/annonc/mdx375

Authors

S. Karim1, K. Ding2, P. Bradbury3, P. Ellis4, N. Mittman5, X. Xiaoqun Sun6, M. Millward7, G. Liu8, S. Sun9, M.R. Stockler10, V. Cohen11, N. Blais12, R. Sangha13, M. Boyer14, R. Sasidharan15, C. Lee16, F.A. Shepherd8, G. Goss17, L. Seymour6, N.B. Leighl18

Author affiliations

  • 1 Department Of Medical Oncology, Queen's University, K7L 3N6 - Kingston/CA
  • 2 Canadian Clinical Trials Division, Queen's University, K7L 3N6 - Kingston/CA
  • 3 Medical Oncology, Princess Margaret Cancer Centre, Toronto/CA
  • 4 Department Of Oncology, McMaster University, Hamilton/CA
  • 5 Sunnybrook Research Institute, University of Toronto, Toronto/CA
  • 6 Ncic Clinical Trials Group, Cancer Research Institute, Queen's University, K7L 3N6 - Kingston/CA
  • 7 Medical Oncology, School of Medicine and Pharmacology Sir Charles Gairdner Hospital, 6009 - Nedlands/AU
  • 8 Department Of Medical Oncology And Hematology, Princess Margaret Cancer Centre, M5G 2M9 - Toronto/CA
  • 9 Medical Oncology, BC Cancer Agency, Vancouver/CA
  • 10 Medical Oncology, NHMRC Clinical Trials Centre, 1450 - Camperdown/AU
  • 11 Oncology, Sir Mortimer B. Davis-Jewish General Hospital, H3T 1E2 - Montreal/CA
  • 12 Medical Oncology, Notre Dame du CHUM, H2L 4M1 - Montreal/CA
  • 13 Medical Oncology, University of Alberta Cross Cancer Institute, T6G 1Z2 - Edmonton/CA
  • 14 Medical Oncology, Chris O'Brien Lifehouse, 2050 - Camperdown/AU
  • 15 Medical Oncology, Auckland City Hospital, 1023 - Auckland/NZ
  • 16 Medical Oncology, British Columbia Cancer Agency, Surrey/CA
  • 17 Oncology, The Ottawa Hospital Cancer Centre, Ottawa/CA
  • 18 Oncology, Cancer Clinical Research Unit (CCRU), Princess Margaret Cancer Centre, Toronto/CA
More

Resources

Abstract 3049

Background

Dacomitinib, a potent irreversible pan-HER kinase inhibitor, has activity in EGFR mutant (mt) lung cancer. BR.26, completed in 2013, compared dacomitinib versus placebo in unselected pts who had received both chemotherapy (1 or 2 lines) and a first-generation EGFR TKI for advanced NSCLC. Dacomitinib pts had significantly improved tumour response rate, PFS, and time to symptom deterioration but not improved survival (OS). A trend towards improved OS was seen in pts with KRAS wildtype (wt) tumours (KRAS unknown in 42%). A prospective economic evaluation was planned for Canadian and Australian pts.

Methods

Resource utilization and utility scores (EQ5D-3L) were collected prospectively in 385 trial participants from Canada and Australia. Direct medical costs were applied to resources in 2015 Canadian dollars (CAD) from the Canadian public health care payer perspective. Dacomitinib is not approved for marketing, thus we used a range of plausible drug costs (0-$120/mg). Restricted mean survival time, utility, and costs per arm were calculated, and explored in KRAS wt and EGFR mt subgroups.

Results

Incremental outcomes and costs by treatment arm are shown below. Mean utility scores were similar, although higher in dacomitinib-treated pts with KRAS wt or EGFR mt tumours (range u = 0.41- 0.55). Mean quality-adjusted survival was approximately 1 month longer with dacomitinib in both KRAS wt and EGFR mt subgroups. Direct medical costs excluding dacomitinib were similar between arms. Exploratory estimates of cost-utility ranged from $26,369-$184,701/QALY in KRAS wt, and $2,243-$133,953/QALY in pretreated EGFR mt pts.

Conclusions

Dacomitinib in previously treated, unselected NSCLC may yield minor gains in quality-adjusted survival without increasing other costs of care. Analyses of mutation status by ctDNA are ongoing.Table:

1121P

Incremental mean outcome with dacomitinib over placeboAll patients (n = 385)KRAS wild type (KRAS known n = 165)EGFR mutant (EGFR known n = 80)
Survival (ΔE, years)0.00140.1040.129
Quality-adjusted survival (ΔE, QALY)0.0110.0690.088
Cost (ΔC, 2015 CAD) Set drug price at: $0/mg $40/mg $80/mg $120/mg$524 $3,944 $7,363 $10,783$1,829 $5,489 $9,149 $12,809$199 $4,083 $7,968 $11,853

Clinical trial identification

2009-016509-41

Legal entity responsible for the study

Canadian Clinical Trials Group (CCTG)

Funding

Pfizer

Disclosure

P. Bradbury: Honorarium from Pfizer and Merck. P. Ellis: In the past two years, received honoraria for talks from Boehringer Ingelheim and Novartis. G. Liu: Honoraria from AstraZeneca, Pfizer, Novartis and Takeda. R. Sangha: Honoraria from: Pfizer, Boehringer Ingelheim, AstraZeneca, Roche, Eli-Lilly, Bristol-Myers Squibb and Merck. M. Boyer: I’ve received Honoraria (paid to my institution) from Pfizer, Boehringer Ingelheim and Astra Zeneca. G. Goss: Honoraria from Pfizer, AstraZeneca, Boehringer Ingelheim, Lilly, Bristol-Myers Squibb, and Celgene. L. Seymour: Pfizer provided funding for the BR.26 trial. N.B. Leighl: Research funding (institution) - Novartis Unrelated CME (not speaker\'s bureau) - travel/honoraria - AstraZeneca, Merck Sharpe Dohme, Pfizer, Bristol-Myers Squibb. All other authors have declared no conflicts of interest.

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