TOP-LINE DATA FROM THE RANDOMIZED PHASE 2 IMPULSE STUDY IN SMALL-CELL LUNG CANCER (SCLC): IMMUNOTHERAPEUTIC MAINTENANCE TREATMENT WITH LEFITOLIMOD
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1 Abstract #1527O TOP-LINE DATA FROM THE RANDOMIZED PHASE 2 IMPULSE STUDY IN SMALL-CELL LUNG CANCER (SCLC): IMMUNOTHERAPEUTIC MAINTENANCE TREATMENT WITH LEFITOLIMOD M. Thomas, S. Ponce-Aix, A. Navarro Mendivil, J. Riera-Knorrenschild, M. Schmidt, M. Krikov, E. Wiegert, M. Dómine Gómez, J. Kollmeier, P. Sadjadian, K.-P. Fröhling, R. Huber, and M. Wolf - for the IMPULSE study team Prof. Dr. Michael Thomas, MD Head, Dep. Thoracic Oncology/Internal Medicine Thoraxklinik/University of Heidelberg Röntgenstraße 1, Heidelberg - Germany esmo.org
2 DISCLOSURE SLIDE M. Thomas Advisory-Board / Speaker Honoraria: Astrazenca, BMS, Boehringer, Celgene, Chugai, Lilly, Mologen AG, MSD, Novartis, Pfizer, Roche Study sponsored by Mologen AG
3 Rationale for Phase II IMPULSE Trial in SCLC Extensive-disease small-cell lung cancer (SCLC) Poor outcome (median OS 9-11 months) - high medical need High response rate with 1 st line chemotherapy - limited period of disease stability in responders No progress in competing developments for decades IO currently under exploration Hypothesis Activation of immune system might prolong disease stability in responders and impact survival s mode-of-action DNA-based TLR9 agonist - no chemical modification, covalently-closed Takes advantage of the decreased tumor burden and released tumor antigens due to chemotherapy Initiates immune surveillance via activation of innate & adaptive immune system Ú High risk / high reward strategy based on lefitolimod s mode-of-action
4 Mode-of-action of TLR9 Agonist Targeting TLR9-positive cells Internalized, binds to TLR9 in endosome Activation of innate immune system Initially IFN-alpha by pdc NK and NKT cells, monocytes Chemokine IP-10 (CXCL10) Activation of adaptive immune system Up-take of released tumor-associated antigens (TAA) by DC T cell activation IP-10: IFN-g-induced protein 10, CXCL10 Kapp, 2014; Schmidt, 2015; Wittig, 2015 Ú Reactivation of immune surveillance via broad enhancement of innate and adaptive immune system
5 Study Design of the IMPULSE Trial Study flow chart Exploratory, randomized, controlled, two-arm, multinational Phase II clinical trial Administration of lefitolimod: 60mg twice-weekly, subcutaneously 102 patients in 41 centers in Belgium, Austria, Germany and Spain First patient in Apr-2014, enrollment completed Oct-2015, top-line results Apr-2017, follow-up ongoing Ú Exploratory phase II trial for overall survival (OS) signal generation
6 Study Endpoints Primary endpoint Overall survival (OS) in intent-to-treat population (ITT) Selected secondary endpoints Progression-free survival (PFS) Best objective response rate (ORR) Pre-planned subgroup analysis -related parameter (immunological marker, e.g. activated B cells) Indication-specific parameter (e.g. COPD) Pharmacodynamic response for confirmation of lefitolimod s mode-of-action Safety profile of lefitolimod Ú All endpoints evaluated in ITT and selected subgroup populations
7 Eligibility Criteria Selected eligibility criteria Patients with extensive-disease SCLC Completion of 4 cycles of first-line therapy with a platinum-based regimen Documented tumor response (PR or CR) ECOG performance status 0 or 1 No prior or current paraneoplastic syndrome related to SCLC No history of autoimmune disease or immune deficiency No systemic steroid-treatment Ú Corresponds to the usual extensive-disease SCLC study patient population 7
8 Patient Demographics (N=61) CONTROL (N=41) Age [years] Mean Min - Max Sex Female 22 (36.1%) 12 (29.3%) Male 39 (63.9%) 29 (70.7%) Race White 61 ( 100%) 41 ( 100%) ECOG* 0 18 (30%) 18 (46,2%) 1 42 (70%) 21 (53,8%) Smoking Status No 1 ( 1.6%) 2 ( 4.9%) Yes 60 (98.4%) 39 (95.1%) Reported COPD Yes 16 (26.2%) 9 (22.0%) No 45 (73.8%) 32 (78.0%) Brain metastases Yes 12 (19.7%) 7 (17%) No 49 (80.3%) 34 (83%) *data available for 99 patients (safety population) Ú Balanced distribution between study arms 8
9 Selection of Pharmacodynamic Marker s mode-of-action Targeting TLR9-positive pdc Activation of NK, NKT, and T cells Activation of monocytes Secretion of chemokine IP-10 Ú Assessed as pharmacodynamic parameters Blood sampling: before lefitolimod and during study (after at least 4 weeks) Kapp, 2014; Schmidt, 2015; Wittig, 2015 Central analysis: Monocytes (flow cytometry) / IP-10 (IFN-γ-induced protein 10) via multiplex assay Ú Standardized detection of pharmacodynamic marker to confirm lefitolimod s mode-of-action
10 Pharmacodynamic Evaluation (1/2) Analysis of activation status of monocytes in the ITT population Central flow cytometry of peripheral blood samples for CD169 + monocytes Paired samples: lefitolimod n=54 (p<0.0001*), control n=32 (p=0.14*), *paired t-test CD169 + monocytes [%] mean 8.4% baseline maximum fold mean 86.1% mean 7.7% baseline maximum 2.1- fold mean 16.1% Ú Significant increase of CD169 + monocytes confirms lefitolimod s mode-of-action
11 Pharmacodynamic Evaluation (2/2) Analysis of serum level of chemokine IP-10 in the ITT population Central multiplex assay of serum samples for IP-10 levels Paired samples: lefitolimod n=59 (p<0.0001*), control n=33 (p=0.03*), *paired t-test 3, fold 3, fold IP-10 [pg/ml] 2,000 1,000 2,000 1,000 0 mean baseline maximum mean mean baseline maximum mean Ú Significant increase of IP-10 level confirms lefitolimod s mode-of-action
12 Safety Evaluation Treatment duration with lefitolimod Median: 72 days Mean: days Treatment-emergent adverse events Adverse events (total > 10%)* (N=61) N pts (%) / N pts with grade 3 (%) Cough 15 (25.0%) / 1 (1.7%) 3 (7.7%) Asthenia 8 (13.3%) / 1 (1.7%) 7 (17.9%) Headache 13 (21.7%) / 2 (3.3%) 2 (5.1%) (N=41) N pts (%) / N pts with grade 3 (%) Nausea 7 (11.7%) / 1 (1.7%) 8 (20.5%) / 1 (2.6%) Back pain 8 (13.3%) / 1 (1.7%) 5 (12.8%) Fatigue 10 (16.7%) 3 (7.7%) Dyspnoea 8 (13.3%) / 1 (1.7%) 4 (10.3%) / 1 (2.6%) Erythema 11 (18.3%) --- Anaemia 8 (13.3%) 2 (5.1%) Decreased appetite 6 (10.0%) 4 (10.3%) *no grade 4 or grade 5 AE reported Ú Limited add-on toxicity in combination with chemotherapy
13 Overall Survival - ITT Population OS in the ITT study population Primary endpoint 102 Patients recruited arm: 61 arm: 41 Overall survival) n=102 Median OS [95% CI] (n=61) days [233.0; 320.0] (n=41) days [231.0; 434.0] HR [95% CI] 1.27 [0.80; 2.01] p= Patients at risk Time to event (days) Ú No statistical significant difference between the study arms
14 OS in Subgroups Reported COPD OS in pre-defined subgroup Patients with reported Chronic Obstructive Pulmonary Disease (COPD) at baseline N=25 Overall survival n=25 Median OS [95% CI] (n=16) days [277.0; 422.0] HR [95% CI] 0.54 [0.21; 1.38] (n=9) days [133.0; n.a.] Patients at risk Time to event (days) Ú OS signal in patients with reported COPD history (HR=0.54)
15 OS in Subgroups Activated B Cells (1/3) OS in pre-defined subgroup Patients with low number of activated B cells at baseline N=38 N=23 Overall survival n=38 Median OS [95% CI] (n=23) days [188.0; 423.0] HR [95% CI] 0.59 [0.29; 1.21] (n=15) days [171.0; 272.0] N= Patients at risk Time to event (days) Ú Strong OS signal in patients with low number of activated B cells (HR=0.59, 95% CI: )
16 OS in Subgroups Activated B Cells (2/3) Assessment of B cell biomarker Analyses of blood samples before start of lefitolimod treatment (visit 1) Flow cytometry in a central laboratory Activated B Cells: Defined as proportion of CD86 + of CD19 + B-cells Ú Evaluable in 88 of 102 patients All patients (ITT) Patients with blood samples Cut-off* determined as 15.4% activated B cells Ú 38 from 88 evaluable patients below cut-off Patients <15.4% activated B cells 38 Evaluation of the OS in this subgroup (N=38) *Cut-off detection: Determination of the cut-off with the smallest p-value in univariate Cox regression model (without treatment) Ú Objective biomarker evaluated via validated assay in a central laboratory
17 OS in Subgroups Activated B Cells (3/3) Robustness of OS signal in patient subgroup with low count of activated B Cells Median 16.9 > Robust signal across different analyses Median Quartiles Quintiles Quartiles Quintiles > Delineated cut-off * > 23.8 * Cut-off detection: Determination of the cut-off with the smallest p-value in univariate Cox regression model (without treatment) Cut-off* 15.4 > 15.4 % activated HR 95% CI B cells favors favors Ú Robust positive OS signal for subgroup with low count of activated B-cells across different analyses
18 Hypothesis for Activated B Cell Subgroup enables immune response targeting tumor cells 18 Kapp, 2014; Schmidt, 2015; Wittig, 2015
19 Hypothesis for Activated B Cell Subgroup enables immune response targeting tumor cells Activated B cells suppress lefitolimod-triggered response Activated B cells include the population of B cells with regulatory function (B reg ) B reg generated due to release of specific tumor cytokines B reg play a role during tumor development Inhibition of cytotoxic T cells, NK cells, M1 macrophages Suppression of anti-tumor responses Kapp, 2014; Schmidt, 2015; Wittig, 2015 Ú Possible inhibition of lefitolimod-induced anti-tumor effect 19 Rosser, 2015; Zhang, 2015; Schwartz, 2016; Yuen, 2016; Mauri, 2017
20 Hypothesis for Activated B Cell Subgroup enables immune response targeting tumor cells Activated B cells suppress lefitolimod-triggered response Activated B cells include the population of B cells with regulatory function (B reg ) B reg generated due to release of specific tumor cytokines B reg play a role during tumor development Inhibition of cytotoxic T cells, NK cells, M1 macrophages Suppression of anti-tumor responses Kapp, 2014; Schmidt, 2015; Wittig, 2015 Ú Possible inhibition of lefitolimod-induced anti-tumor effect 20 Rosser, 2015; Zhang, 2015; Schwartz, 2016; Yuen, 2016; Mauri, 2017 Ú Low number of activated B cells may facilitate lefitolimod s full anti-cancer effect
21 Summary and Conclusion Exploratory, randomized, controlled Phase II trial of lefitolimod in 102 patients with extensive-disease SCLC and CR/PR after induction chemotherapy Evaluation of overall survival (OS) in ITT Ú No significant difference in OS Assessment of pharmacodynamic marker Ú Confirmation of lefitolimod s mode-of-action Safety assessment Ú Favorable safety profile OS in pre-defined subgroups Ú Strong OS signal in population with low count of activated B cells Hypothesis: Inhibition of lefitolimod-induced anti-tumor effect by activated / regulatory B cells Low number of activated B cells may facilitate lefitolimod s full anti-cancer effect Ú Next steps: Validation of efficacy in patient proportion with low count of activated B cells
22 Acknowledgements All participating patients and their families IMPULSE investigators and the site staff
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