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C. Chouaid
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ORAL 18 - Non PD1 Immunotherapy and Angiogenesis (ID 114)
- Event: WCLC 2015
- Type: Oral Session
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:C. Butts, K. Reckamp
- Coordinates: 9/08/2015, 10:45 - 12:15, Four Seasons Ballroom F1+F2
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ORAL18.01 - TG4010 Immunotherapy plus Chemotherapy as First Line Treatment of Advanced NSCLC: Phase 2b Results (ID 669)
10:45 - 12:15 | Author(s): C. Chouaid
- Abstract
- Presentation
Background:
TG4010 is an immunotherapy using an attenuated and modified poxvirus (MVA) coding for MUC1 and interleukin-2. Previous Phase 2 trials have demonstrated the efficacy and safety of TG4010 in combination with chemotherapy. In addition, Triple Positive Activated Lymphocytes (TrPAL; CD16+, CD56+, CD69+) was identified as a potential biomarker predictive of efficacy
Methods:
TIME is a double blind, placebo-controlled phase 2b/3 study. The Phase 2b part compared first line chemotherapy combined with TG4010 or placebo and further assessed the predictive value of baseline level of TrPAL. Eligibility criteria included stage IV NSCLC not previously treated, MUC1+ tumor by immunohistochemistry, PS ≤1. TG4010 10[8] pfu or placebo was given SC weekly for 6 weeks (w), then every 3w up to progression in immediate combination with chemotherapy. Patients were randomized using TrPAL cut-off value (normal vs high) that was previously pre-determined in healthy subjects. Primary efficacy endpoint was progression-free survival (PFS) using a Bayesian design to confirm that, with a 95% probability, the true hazard ratio (HR) is <1 in patients with normal TrPAL level. Secondary objectives were response rate (ORR), duration of response, survival, safety and subgroup analyses according to histology and level of TrPAL.
Results:
222 patients (pts) were randomized 1:1. In pts with normal TrPAL the study met the primary endpoint with a Bayesian probability of 98.4% that the PFS HR is <1 in favor of TG4010. In the whole study population, ORR was 39.6% vs 28.8% and duration of response was 30.1w versus 18.7w in the TG4010 and placebo arms respectively. Survival data will be presented at the time of the meeting. Preplanned subgroup analyses showed that PFS was significantly improved in the TG4010 arm in pts with low TrPAL (n=152; HR=0.66 [CI95% 0.46-0.95] p= 0.013) while it was not the case in pts with high TrPAL (n=70; HR=0.97 [CI 95% 0.55-1.73] p=0.463). In addition, PFS was also significantly improved in pts with non-squamous tumors (n=196; HR=0.69 [CI95% 0.51-0.94] p=0.009) as well as in pts with non-squamous tumors and low TrPAL (n=131; HR=0.61 [CI95% 0.42-0.89] p=0.005). In this last group, PFS at 9 months was 37% with TG4010 versus 18% with placebo. Frequency and severity of adverse events were similar in both treatment arms except injection site reactions which were more frequent in the TG4010 arm but all of mild or moderate intensity. Exploratory analysis of the impact of PDL1 expression in the tumor of patients treated with TG4010 in TIME study supports the activity of TG4010 whether the tumor is positive or negative for PDL1 expression.
Conclusion:
These results provide additional data supporting the efficacy of TG4010, particularly in patients with non-squamous tumors and/or a low level of TrPAL at baseline. The Phase 3 part of the TIME study is planned to continue in patients with non-squamous tumors with OS as primary endpoint.
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ORAL 27 - Care (ID 123)
- Event: WCLC 2015
- Type: Oral Session
- Track: Advocacy
- Presentations: 1
- Moderators:M.N. Mountain, J. Freeman-Daily
- Coordinates: 9/08/2015, 10:45 - 12:15, 708+710+712
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ORAL27.06 - Disparities in Lung Cancer Incidence and Management Care in France: A Nationwide Cohort Study (the TERRITOIRE Study) (ID 1177)
10:45 - 12:15 | Author(s): C. Chouaid
- Abstract
- Presentation
Background:
Reducing health inequalities in oncology is a major public health priority in France, particularly in terms of social and geographic exclusion and equity of access to health care services. However, no specific registry currently exists for patients with lung cancer allowing description and comparison of local situations. Our aim was to use available National medico-administrative databases to constitute a nationwide population-based cohort study to analyze disparities among French areas (the TERRITOIRE study).
Methods:
We included all patients who had a first diagnosis of lung cancer between January 1rst and December 31th 2011 in the National hospitals databases (PMSI, Programme de Médicalisation des Systèmes d'Information). Patients’ data were linked to create a retrospective cohort study with a two-year follow-up period. The 22 administrative regions were considered in this analysis. In addition of demographic characteristics, metastatic status, comorbidities and treatment procedures, we assigned each patient to socioeconomic deprivation and urbanization scores based on their postcode of residence.
Results:
We identified 41,715 patients newly diagnosed for lung cancer. Mean age at diagnosis was 66.4(±11.9) years and most of patients were men (71.8%). Patients from socioeconomic deprived areas represented 27.5% of the whole lung cancer population, ranging from 9.6% to 55.2% according to the region. Incidences of lung cancer were 35.1 per 100,000 in women and 95.3 per 100,000 in men. Age-standardized incidences showed important disparities between French regions ranging from 27.5 to 55.0 and from 82.4 to 118.2 per 100,000 in women and men, respectively. Higher incidences were found in the northern and eastern regions for men and in the southern and eastern regions for women. Although patients living in rural areas were the larger group (34.5%), Age-standardized incidence significantly increased with urbanization: from 61.8 per 100.000 in rural areas to 73.9 per 100.000 in urban areas. A majority of patients was diagnosed at a metastatic stage (52.7%) and regional disparities were important ranging from 45.0% to 58.1%. This rate also appeared higher in patients diagnosed in public hospitals compared to private ones (56.1% vs 42.9%, p<0.0001) and in local hospitals compared to university ones (60.2% vs 49.6%, p<0.0001). Adjusted comparisons showed significantly higher incidences of stage IV patients at the time of diagnosis in five regions for men and two regions for women. A majority of patients (N=23,842; 57.2%) died in the hospital during the 2-year follow-up, including 15,642 patients (71.2%) having metastasis at the time diagnosis.
Conclusion:
We have demonstrated that a comprehensive population-based cohort using medico-administrative data is a suitable approach to illustrate disparities in lung cancer incidence, management care and outcomes in France. Data from this study should help local clinical teams and health stakeholders to better understand inequality issues in their areas.
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