Journal Thoracic Oncology

Abstracts Journal of Thoracic Oncology • Volume 12 Issue S1 January 2017
NETHERLANDS
Robert Schouten, Paul Baas, Michael Van Den Heuvel
Thoracic Oncology, Netherlands Cancer Institute / Antoni Van Leeuwenhoek,
Amsterdam/Netherlands
Background: Randomized phase III trials have shown that the PD-1 blocking
monoclonal antibody Nivolumab is effective in advanced NSCLC. Nivolumab is
registered by the FDA and EMA for treatment of NSCLC. However, approval in
The Netherlands was put on hold because of Nivolumab’s high price per
quality adjusted life year (QALY). From August 2015, Nivolumab was provided
through a compassionate use program. Here we present our experience in
treating NSCLC patients with Nivolumab in real life. Methods: Efficacy and
safety of Nivolumab was assessed in patients with advanced NSCLC,
previously treated with at least one line of platinum-based chemotherapy and
an ECOG-PS of ≤2. Nivolumab was administered 2-weekly at a dose of 3 mg/kg
intravenously. Response evaluation took place according to RECIST 1.1 at 12
and 24 weeks after start of treatment. Results: In the 10-month period in a
single center 189 patients started treatment with Nivolumab, with a mean
follow up time of 106 days after start of treatment. Mean age was 62 years
(range 29–83), 57% male, 18,5% never smoked, 68% had adenocarcinoma, 20%
had squamous histology and 12% were other, mixed or unspecified types.
(NSCLC). Methods: We used The Health Economics Medical Innovation
Simulation (THEMIS) alongside available clinical trial data to estimate the
anticipated increase in NSCLC patient survival post-diagnosis resulting from
the introduction of IO therapy. THEMIS is an established microsimulation
with a 50-year time horizon that tracks a representative sample of patients
aged ≥51 years to project longevity. These outcomes were estimated for
metastatic NSCLC patients under a pre-IO scenario and compared to a post-
IO scenario where IO is available for either first- or second-line treatment.
Patients were classified as either heavy, medium, or light responders,
corresponding to reductions in mortality hazards of 96.5%, 64.4%, and 0%,
respectively, based on extrapolations of clinical trial results for nivolumab
(see table). Health state transitions probabilities and medical expenditures
were estimated from nationally representative datasets. Mortality and
disease stage were estimated using the Surveillance and Epidemiology End
Results (SEER) database. Results: In the pre-IO simulation, metastatic NSCLC
patients lose 11.3 years of life (comparable with the published 11.8 years). The
results from the post-IO scenarios are shown in the table. For comparison,
SEER data suggest that survival in metastatic NSCLC patients has only
increased by 0.3 years since 1998.
Population
Second-line
monotherapy,
All
patients
First-line
monotherapy,
PD-L1
>1%
First-line
monotherapy,
PD-L1
>50%
First-line
combination
therapy,
PD-L1 >1%
First-line
combination
therapy, PD-
L1 >50%
Heavy
Responder
Prevalence
Medium
Responder
Prevalence
Heavy
Responder
Hazard
Reduction
Medium
Responder
Hazard
Reduction
20% 30% 96.5% 64.4% 0% 2.1
Light Responder
Hazard
Reduction
Additional
Life
Years
30% 40% 96.5% 64.4% 0% 3.25
50% 40% 96.5% 64.4% 0% 4.72
60% 30% 96.5% 64.4% 0% 4.22
100% 0% 96.5% N/A N/A 7.06
Conclusion: Current IO therapies represent a significant step towards
extending life expectancy for metastatic NSCLC patients.
Twenty-four percent of patients experience immunotherapy related toxicity,
most toxicities were short-term or easily manageable. No grade 5 toxicities,
one grade 4 hepatitis and one grade 3 hypophysitis were observed.
Hypothyroidism was most frequently observed (gr.1-2; 9,5%), followed by
skin-reactions (gr.1-3; 3,8%) and colitis (gr.1-2; 3,2%). Other immune related
toxicities were hepatitis (gr.1-4; 2,5%), infusion reactions (gr.1; 2,5%),
pneumonitis (gr.2; 1,9%), hyperthyroidism (gr.1; 1,3%), arthritis (gr.2; 0,6%),
hypophysitis (gr.3; 0,6%) and diabetes mellitus type 1 (gr.3, 0,6%). Conclusion:
Although follow up is short and response data not yet mature, real-life
efficacy and safety data from Nivolumab are comparable to phase III trial
data.
Keywords: Immunotherapy, Safety, efficacy, NSCLC
MA14: IMMUNOTHERAPY IN ADVANCED NSCLC: BIOMARKERS AND COSTS
TUESDAY, DECEMBER 6, 2016 - 16:00-17:30
MA14.09 DEMONSTRATING LIFE EXPECTANCY GAINS WITH
IMMUNO-ONCOLOGY (IO) THERAPIES
Jeffrey Sullivan 1 , Alison Sexton Ward 1 , Beata Korytowsky 2 , Desi Peneva 1 ,
Jennifer Benner 1 , Darius Lakdawalla 3 , Bjorn Bolinder 2 , Robert Figlin 4 , Anupam
Jena 5
1 Precision Health Economics, Los Angeles/CA/United States of America, 2 Bristol-
Myers Squibb, Princeton/NJ/United States of America, 3 University of Southern
California, Los Angeles/CA/United States of America, 4 Cedars-Sinai Medical Center,
Los Angeles/CA/United States of America, 5 Harvard Medical School, Boston/MA/
United States of America
Background: Immuno-oncology (IO) therapies offer the possibility of longterm
survival to metastatic cancer patients. Prior analyses have shown that
lung cancer reduces life expectancy by an average of 11.8 years (Burnet NG,
et al. Br J Cancer. 2005;92:241-245.). We aimed to investigate the impact of
IO therapies on life extension of patients with non-small cell lung cancer
Keywords: immuno-oncology, non-small cell lung cancer, survival, Life
expectancy
MA14: IMMUNOTHERAPY IN ADVANCED NSCLC: BIOMARKERS AND COSTS
TUESDAY, DECEMBER 6, 2016 - 16:00-17:30
MA14.10 RELATIVE IMPACT OF DISEASE MANAGEMENT COSTS IN
THE ECONOMICS OF PEMBROLIZUMAB IN PREVIOUSLY TREATED
PD-L1 POSITIVE ADVANCED NSCLC
Min Huang 1 , Yanyan Lou 2 , James Pellissier 1 , Thomas Burke 3 , Frank Liu 1 ,
Vamsidhar Velcheti 4
1 Center for Observational and Real-World Evidence, Merck & Co., Inc, North Wales/
PA/United States of America, 2 Hematology/Oncology, Mayo, Jacksonville/FL/
United States of America, 3 Center for Observational and Real-World Evidence,
Merck & Co., Inc., Lebanon/NJ/United States of America, 4 Solid Tumor Oncology,
Cleveland Clinic, Cleveland/OH/United States of America
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 basecase
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.
S218 Journal of Thoracic Oncology • Volume 12 Issue S1 January 2017