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M. Reck
Moderator of
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Closing remarks (ID 51)
- Event: ELCC 2017
- Type: Closing remarks
- Track:
- Presentations: 1
- Moderators:M. Reck, A.G. Nicholson
- Coordinates: 5/08/2017, 12:50 - 13:00, Room A
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Closing remarks (ID 576)
12:50 - 13:00 | Author(s): A.G. Nicholson
- Abstract
Abstract not provided
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Is there a role for second-line immunotherapy in patients with PD-L1 negative NSCLC? (ID 22)
- Event: ELCC 2017
- Type: Controversy session
- Track:
- Presentations: 4
- Moderators:M. Reck, L. Paz-Ares
- Coordinates: 5/07/2017, 09:15 - 10:15, Room A
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Introduction and first vote (ID 89)
09:15 - 10:15 | Author(s): M. Reck
- Abstract
Abstract not provided
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No (ID 91)
09:15 - 10:15 | Author(s): B. Besse
- Abstract
Abstract not provided
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Second vote and conclusions (ID 92)
09:15 - 10:15 | Author(s): L. Paz-Ares
- Abstract
Abstract not provided
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Yes (ID 90)
09:15 - 10:15 | Author(s): R. Herbst
- Abstract
- Presentation
Abstract not provided
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Keynote lecture: Genetic profiling of lung cancer (ID 16)
- Event: ELCC 2017
- Type: Keynote Lecture
- Track:
- Presentations: 1
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Genetic profiling of lung cancer (ID 67)
14:10 - 14:40 | Author(s): M. Meyerson
- Abstract
- Presentation
Abstract not provided
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Opening and welcome (ID 34)
- Event: ELCC 2017
- Type: Opening and welcome
- Track:
- Presentations: 0
- Moderators:M. Reck, A.G. Nicholson
- Coordinates: 5/05/2017, 13:30 - 13:45, Room B
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The role of antiangiogenic agents in NSCLC: Are we making progress? (ID 43)
- Event: ELCC 2017
- Type: Young Oncologist session
- Track:
- Presentations: 2
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Biomarker approaches for optimisation of antiangiogenic therapy (ID 138)
08:00 - 08:50 | Author(s): M. Reck
- Abstract
- Presentation
Abstract not provided
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State of the art in first and subsequent lines of the NSCLC treatment (ID 134)
08:00 - 08:50 | Author(s): B. Besse
- Abstract
Abstract not provided
Author of
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Immunotherapy of non-small cell lung cancer (ID 4)
- Event: ELCC 2017
- Type: Educational session
- Track:
- Presentations: 1
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First-line treatment (ID 12)
16:30 - 18:00 | Author(s): M. Reck
- Abstract
- Presentation
Abstract not provided
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Is there a role for second-line immunotherapy in patients with PD-L1 negative NSCLC? (ID 22)
- Event: ELCC 2017
- Type: Controversy session
- Track:
- Presentations: 1
- Moderators:M. Reck, L. Paz-Ares
- Coordinates: 5/07/2017, 09:15 - 10:15, Room A
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Introduction and first vote (ID 89)
09:15 - 10:15 | Author(s): M. Reck
- Abstract
Abstract not provided
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Poster Display Session (ID 63)
- Event: ELCC 2017
- Type: Poster Display Session
- Track:
- Presentations: 5
- Moderators:
- Coordinates: 5/07/2017, 12:30 - 13:00, Hall 1
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120P - Subgroup analysis of adenocarcinoma patients refractory to first-line chemotherapy from REVEL: A randomized phase III study of docetaxel with ramucirumab or placebo for second-line treatment of stage IV non–small cell lung cancer (NSCLC) (ID 423)
12:30 - 13:00 | Author(s): M. Reck
- Abstract
Background:
In the phase III REVEL trial, ramucirumab plus docetaxel significantly improved median overall survival (OS), median progression-free survival (PFS), and objective response rate (ORR) in patients with advanced NSCLC who progressed after first-line platinum therapy, independent of histology. The REVEL trial also showed that ramucirumab plus docetaxel therapy improved median OS, median PFS, and ORR in adenocarcinoma patients who were refractory to first-line platinum therapy and in patients categorized as rapid progressors. Here, we report safety and quality of life (QoL) outcomes in refractory adenocarcinoma patients who participated in the REVEL trial.
Methods:
Patients were refractory if they had a best response of progressive disease to first-line treatment. Patients were randomized 1:1 to receive docetaxel 75 mg/m[2] in combination with either ramucirumab 10 mg/kg or placebo every 21 days until disease progression, unacceptable toxicity, or death. Treatment-emergent adverse events (TEAEs) were assessed according to the NCI-CTCAE, version 4.0. Quality of life was measured by the Lung Cancer Symptom Scale (LCSS).
Results:
Of the 1253 patients randomized (ramucirumab + docetaxel: 628; docetaxel + placebo: 625), 17% (ramucirumab + docetaxel: 9%; docetaxel + placebo: 8%) were adenocarcinoma patients refractory to first-line therapy. The safety overview and LCSS scores are presented in the table.rnTable: 120PSafety and QoL Outcomes of Refractory Adenocarcinoma Patients Treated in REVELrnrn
rnNote: The primary LCSS analysis was time to deterioration, defined as the time from randomization to the first 15 mm increase. ASBI, average symptom burden index; CI, confidence interval; LCSS, Lung Cancer Symptom Scale; QoL, quality of life; TEAE, treatment-emergent adverse event.rnrn rnrnTEAEs, n (%) rnRamucirumab + Docetaxel N = 111 rnPlacebo + Docetaxel N = 101 rnrn rnAny TEAE rn108 (97) rn101 (100) rnrn rnGrade ≥3 TEAEs rn82 (74) rn73 (72) rnrn rnSerious TEAEs rn47 (42) rn48 (48) rnrn rnTEAEs leading to discontinuation rn6 (5) rn4 (4) rnrn rnTEAEs leading to death rn4 (4) rn11 (11) rnrn rnrn rn rnLCSS scores, time to deterioration rnHazard Ratio (95% CI) rnrn rn rnrn rn rnLoss of appetite rn1.45 (0.91, 2.32) rnrn rn rnFatigue rn0.90 (0.58, 1.41) rnrn rn rnCough rn1.29 (0.77, 2.14) rnrn rn rnDyspnea rn1.06 (0.64, 1.76) rnrn rn rnHemoptysis rn1.55 (0.59, 4.07) rnrn rn rnPain rn1.14 (0.71, 1.84) rnrn rn rnSymptom distress rn1.12 (0.69, 1.81) rnrn rn rnActivity level rn1.01 (0.64, 1.59) rnrn rn rnGlobal QoL rn0.98 (0.63, 1.52) rnrn rn rnTotal LCSS rn0.81 (0.47, 1.41) rnrn rn rnrnASBI rn0.83 (0.46, 1.50) rnrn
Conclusions:
Our analysis did not identify any new safety concerns or increased detriment in QoL for this subgroup of patients. Safety outcomes for refractory adenocarcinoma patients were consistent with the outcomes for refractory patients with all histologies and the intent-to-treat population.
Clinical trial identification:
NCT01168973
Legal entity responsible for the study:
Eli Lilly and Company
Funding:
Eli Lilly and Company
Disclosure:
M. Reck: Personal fees from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, Hoffmann-La Roche, Merck Sharp & Dohme, Novartis, and Pfizer. L. Paz-Ares: Personal fees from AMGEM, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, CLOVIS, Eli Lilly and Company, Hoffmann-La Roche, Merck Sharp & Dohme, Novartis, and Pfizer. D. Moro-Sibilot: Personal fees from AMGEN, Ariad, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, Hoffmann-La Roche, Merck Sharp & Dohme, Novartis, and Pfizer. F.A. Shepherd, M. Pérol: Personal fees from Eli Lilly and Company. F. Cappuzzo: Personal fees from AstraZeneca, Hoffmann-La Roche, and Pfizer. K.B. Winfree: Employee of Eli Lilly and Company and reports personal fees from Eli Lilly and Company. E. Alexandris: Employee of Eli Lilly and Company. A. Sashegyi, R. Varea: Employee and shareholder of Eli Lilly and Company.
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139TiP - A non-interventional biomarker study in patients (pts) with non-small cell lung cancer (NSCLC) of adenocarcinoma histology who are treated with nintedanib according to the approved label (LUME-BioNIS) (ID 260)
12:30 - 13:00 | Author(s): M. Reck
- Abstract
Background:
Nintedanib+docetaxel significantly improved overall survival (OS) of pts with advanced adenocarcinoma NSCLC. There are currently no validated tumour- or serum-derived biomarkers to predict the efficacy of antiangiogenic therapy. The objective of this study is to investigate whether tumour-based gene/protein expression patterns or genomic markers, alone or combined with clinical covariates, could predict treatment effect in pts with adenocarcinoma NSCLC receiving nintedanib (Vargatef[®]).
Trial design:
In this non-interventional study at 86 mainly European sites, new biomarker data and clinical characteristics will be collected from ∼300 pts who receive nintedanib as part of routine treatment. Pts must be eligible for nintedanib+docetaxel, i.e. have advanced adenocarcinoma NSCLC after first-line chemotherapy, and will receive nintedanib 200 mg twice daily (Days 2–21 of 21-day cycle) and docetaxel (75 mg/m[2]; Day 1). The primary outcome is OS in relation to exploratory biomarker assessment, including gene expression profile, tumour genomic alterations and protein analysis. Tumour tissue samples obtained prior to first-line therapy are required along with informed consent. Mutation analysis of nintedanib target genes (VEGFR1–3, FGFR1–3, PDGFR α/β) and driver genes (EGFR, KRAS, ALK, BRAF, PIK3CA) will be conducted, as well as evaluation of tumour protein expression (e.g. PD-L1, CD133) and proliferation (Ki-67) markers by immunohistochemistry. One ∼2 mL blood sample (or a buccal swab) will be collected at baseline or after nintedanib initiation alongside routine blood sampling to analyse the potential influence of genetic variants in angiogenesis-related genes (e.g. single nucleotide polymorphisms in VEGFR1). Pts will be followed up every 6 months. The primary outcome will be analysed after 250 deaths. Gene expression patterns and tumour genomics in relation to efficacy will be analysed using univariate and multivariate regression models. Adverse events will be assessed. All analyses will be exploratory and considered hypothesis-generating. The study is ongoing (NCT02671422).
Clinical trial identification:
NCT02671422
Legal entity responsible for the study:
Boehringer Ingelheim Pharma GmbH & Co. KG
Funding:
Boehringer Ingelheim Pharma GmbH & Co. KG
Disclosure:
M. Reck: Author reports personal fees from Boehringer-Ingelheim, Hoffmann-La Roche, Lilly, MSD, BMS, AstraZeneca, Celgene, Merck and Pfizer. K. Kerr: Personal fees from Boehringer Ingelheim, during the conduct of the study. All other authors have declared no conflicts of interest.
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144TiP - CheckMate 227: A randomized, open-label phase 3 trial of nivolumab, nivolumab plus ipilimumab, or nivolumab plus chemotherapy versus chemotherapy in chemotherapy-naïve patients with advanced non-small cell lung cancer (NSCLC) (ID 394)
12:30 - 13:00 | Author(s): M. Reck
- Abstract
Background:
Platinum-based chemotherapy is standard-of-care first-line therapy for most patients with advanced NSCLC, but the clinical benefit is modest. Although first-line nivolumab, an immune checkpoint inhibitor antibody, did not improve progression-free survival or overall survival (OS) versus chemotherapy in patients with advanced NSCLC and ≥5% programmed death-1 ligand 1 (PD-L1) expression, OS compared favorably with historical controls of first-line platinum-based chemotherapy. Combining nivolumab with chemotherapy in this setting may increase the durability of tumor responses and broaden the population of patients to derive benefit. In a multi-cohort phase 1 study (CheckMate 012) in chemotherapy-naïve patients with advanced NSCLC, nivolumab plus chemotherapy had promising clinical activity, regardless of tumor PD-L1 expression, and a manageable safety profile. CheckMate 227 is a 2-part, randomized, open-label phase 3 trial (NCT02477826), evaluating first-line nivolumab, nivolumab plus ipilimumab, or nivolumab plus chemotherapy versus chemotherapy in patients with advanced NSCLC.
Trial design:
Part 1 of CheckMate 227, which has completed accrual, enrolled adult patients with stage IV/recurrent NSCLC, no prior systemic anticancer therapy, and assessment of PD-L1 expression at screening. Patients with ≥1% PD-L1 expression were randomized 1:1:1 to nivolumab, nivolumab plus ipilimumab, or chemotherapy arms; those with <1% PD-L1 expression were randomized 1:1:1 to nivolumab plus ipilimumab, nivolumab plus chemotherapy, or chemotherapy arms. In part 2, ∼480 previously untreated patients with advanced NSCLC, regardless of PD-L1 expression level, will be randomized 1:1 to receive histology-based platinum doublet chemotherapy alone or in combination with nivolumab. Part 2 of CheckMate 227, which is the focus of this presentation, allows for the evaluation of first-line nivolumab plus chemotherapy in a broad group of patients with advanced NSCLC across the PD-L1–expressing continuum.
Clinical trial identification:
NCT02477826
Legal entity responsible for the study:
Bristol-Myers Squibb
Funding:
Bristol-Myers Squibb
Disclosure:
L. Paz-Ares: Served as a medical advisor for the following companies: Lilly, Roche, MSD, BMS, Celgene, Pfizer, Boehringer-Ingelheim, Bayer, Clovis, and AstraZeneca. J. Brahmer: Received research grants and served as an uncompensated advisory board member for Bristol-Myers Squibb. M.D. Hellmann: Received grants from Genentech and Bristol-Myers Squibb. Received personal fees from Genentech, Bristol-Myers Squibb, Merck, AstraZeneca, Novartis, and Janssen. M. Reck: Received consultant fees and served on speaker\'s bureau for the following companies: Roche, Lilly, Bristol-Myers Squibb, MSD, AstraZeneca, Pfizer, Boehringer-Ingelheim, and Celgene. K. O\'Byrne: Received honoraria, speaker bureau and/or travel and registration support for national and international meetings from BMS, Boehringer-Ingelheim, Astrazeneca, Lilly Oncology, Novartis, MSD, Roche-Genentech and Pfizer. H. Borghaei: The institution has a clinical trial agreement w/BMS. Consultant/advisory board member for: BMS, Lilly, Genentech, Celgene, EMD-Serono, Merck, Pfizer, Trovagene, Millenium, & Boehringer-Ingelheim. Received grants from: Millenium, Merck, & Celgene. W.J. Geese, H. Lu: BMS Employee and stock holder. F.E. Nathan: BMS employee. S. Ramalingam: Served on ad hoc scientific advisory board meetings the following companies: Astra Zeneca, BMS, Boehringer Ingelheim, Celgene, Ariad, Amgen, Lilly, Merck, Genentech. Also received honoraria from BMS.
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146TiP - EXalt3: A phase III study of ensartinib (X-396) in anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (ID 473)
12:30 - 13:00 | Author(s): M. Reck
- Abstract
Background:
Ensartinib is a novel, potent anaplastic lymphoma kinase (ALK) small molecule tyrosine kinase inhibitor (TKI) with additional activity against MET, ABL, Axl, EPHA2, LTK, ROS1 and SLK. Ensartinib has demonstrated activity in ALK treatment naïve and previously treated patients and has a generally well tolerated safety profile.
Trial design:
eXalt3 (NCT02767804) is a global, randomized, open-label phase III study comparing the efficacy and safety of ensartinib to crizotinib in ALK- positive TKI naïve non-small cell lung cancer (NSCLC) patients. It is being conducted in > 100 sites in North America, South America, Europe, and the Asia/Pacific region. Enrollment began in 2016. The primary efficacy endpoint is progression free survival (PFS) assessed by independent radiology review. Secondary efficacy endpoints include overall survival, response rates (overall and central nervous system [CNS]), PFS by investigator assessment, time to response, duration of response, and time to CNS progression. Approximately 270 patients with ALK+ NSCLC who have received no prior ALK TKI and up to one prior chemotherapy regimen will be randomized 1:1 to ensartinib 225 mg QD, or crizotinib 250 mg BID, with stratification based on prior chemotherapy, ECOG performance status (PS), CNS metastases and geographic region. Eligibility includes patients ≥ 18 years of age, stage IIIB or IV ALK+ NSCLC. Patients are required to have measurable disease per RECIST 1.1, adequate organ function, and an ECOG PS of ≤ 2. Adequate tumor tissue (archival or fresh biopsy) must be available for central testing. The study has >80% power to detect a superior effect of ensartinib over crizotinib in PFS at a 2-sided alpha level of 0.05.
Clinical trial identification:
NCT02767804
Legal entity responsible for the study:
Xcovery Holding Company
Funding:
Xcovery Holding Company
Disclosure:
L. Horn: Consulting for Xcovery Holding Company, BMS, BI, Abbvie, Genentech, Merck. Y-L. Wu: Speaker fees from AstraZeneca, Roche, Eli Lilly. M. Reck: Honoraria for lectures and consultancy: Hoffmann-La Roche, Lilly, BMS, MSD, AstraZeneca, Merck, Celgene, Boehringer-Ingelheim, Pfizer, Novartis. C. Liang, K. Harrow, V. Oertel, G. Dukart: Full-Time Employee- Xcovery Holding Company. F. Tan: Manager- Xcovery Holding Company Chief Medical Officer- Betta Pharmaceuticals. T.S.K. Mok: Grant/Research Support from AstraZeneca, BI, Pfizer, Novartis, SFJ, Roche, MSD, Clovis Oncology, BMS, Eisai, Taiho; Speaker’s fees with: AstraZeneca, Roche/Genentech, Pfizer, Eli Lilly, BI, MSD, Novartis, BMS, Taiho; Major Stock Shareholder in: Sanomics Ltd.; Advisory Board for: AstraZeneca, Roche/Genentech, Pfizer, Eli Lilly, BI, Clovis Oncology, Merck Serono, MSD, Novartis, SFJ Pharmaceutical, ACEA Biosciences, Inc., Vertex Pharmaceuticals, BMS, geneDecode Co., Ltd., OncoGenex Technologies Inc., Celgene, Ignyta, Inc.; Board of Directors: IASLC, Chinese Lung Cancer Research Foundation Ltd., Chinese Society of Clinical Oncology (CSCO), Hong Kong Cancer Therapy Society (HKCTS).
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58TiP - IMpower133: Phase I/III trial of first-line atezolizumab with carboplatin and etoposide in ES-SCLC (ID 421)
12:30 - 13:00 | Author(s): M. Reck
- Abstract
Background:
Platinum-based chemotherapy (chemo) with etoposide is the current first-line standard of care for the majority of patients (pts) with ES-SCLC. However, survival outcomes remain poor (median OS, < 1 year) despite initial response rates ranging from 50%-70%. Atezolizumab (atezo) is an anti–PD-L1 mAb that prevents the interaction of PD-L1 with its receptors, PD-1 and B7.1, and restores antitumor T-cell activity. Tolerable safety with promising durability of response has been shown with atezo in pts with ES-SCLC: confirmed ORR was 6% (n = 1/17 [partial response]; DOR of 7 mo) by RECIST v1.1 and 24% by immune-related response criteria (irRC; n = 4/17, with 2 pts on atezo for ≥ 12 mo). Preliminary data also indicate the potential synergy between atezo and platinum-based chemo in NSCLC whereby durable responses may translate into improved survival compared with atezo alone. IMpower133 (NCT02763579), a global, Phase I/III, randomized, multicenter, double-blinded, placebo-controlled trial, will evaluate the efficacy and safety of 1L atezo + carboplatin + etoposide compared with placebo + carboplatin + etoposide in treatment-naive pts with ES-SCLC.
Trial design:
Eligibility criteria include ES-SCLC, measurable disease (RECIST v1.1), ECOG PS 0-1 and no prior systemic anticancer treatment. Exclusion criteria include untreated CNS metastases and history of autoimmune disease. Submission of tumor tissue is a study requirement but pts will be enrolled regardless of biomarker status. Stratification factors are sex, ECOG performance status and presence of treated brain metastases. Eligible pts will be randomized 1:1 to receive four 21-day cycles of atezo (1200 mg IV) or placebo in combination with carboplatin (AUC 5 mg/mL/min IV, d 1) and etoposide (100 mg/m[2] IV, d 1-3), followed by maintenance therapy with atezo or placebo until PD per RECIST v1.1. Pts can continue with treatment until persistent radiographic PD, symptomatic deterioration or unacceptable toxicity. Co-primary endpoints are investigator-assessed PFS per RECIST v1.1 and OS. Secondary efficacy endpoints include investigator-assessed ORR and DOR. Safety and tolerability will also be assessed. Approximately 400 pts will be enrolled.
Clinical trial identification:
NCT02763579
Legal entity responsible for the study:
F. Hoffmann-La Roche Ltd/Genentech Inc.
Funding:
F. Hoffmann-La Roche Ltd/Genentech Inc.
Disclosure:
M. Reck: Honoraria for lectures and consultancy with Boehringer-Ingelheim, Hoffmann-La Roche, Lilly, MSD, BMS, AstraZeneca, Celgene, Merck, Pfizer. A.S. Mansfield: Advisory Board: Genentech, BMS, and Trovagene. S.V. Liu: Advisory board/consultant for: Genentech, Pfizer, Ariad, Celgene, Boehringer Ingelheim, Lilly. T.S.K. Mok: Grant/Speaker/AdBoards: AZ, BI, Pfizer, Novartis, SFJ, Roche, MSD, Clovis, BMS, Eisai, Taiho, Lilly, Merck, ACEA, Vertex, BMS, geneDecode, OncoGenex, Celgene, Ignyta, Taiho; Stock: Sanomics; Board: IASLC, CLCRF, CSCO, HKCTS. X. Tang: Roche employee. S. Lam: Roche/Genentech: employee, stock. F. Kabbinavar, A. Lopez-Chavez, A. Sandler: Employee, stock: Roche/Genentech. L. Horn: Advisory board: Genentech; Consulting: Abbvie, Merck, Lilly, Xcovery and EMD Serono.
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The role of antiangiogenic agents in NSCLC: Are we making progress? (ID 43)
- Event: ELCC 2017
- Type: Young Oncologist session
- Track:
- Presentations: 1
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Biomarker approaches for optimisation of antiangiogenic therapy (ID 138)
08:00 - 08:50 | Author(s): M. Reck
- Abstract
- Presentation
Abstract not provided
Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
