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T.S.K. Mok
Moderator of
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Should we use newer generation targeted treatment upfront? (ID 10)
- Event: ELCC 2017
- Type: Controversy session
- Track:
- Presentations: 4
- Moderators:E. Smit, T.S.K. Mok
- Coordinates: 5/06/2017, 09:15 - 10:15, Room A
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Introduction and first vote (ID 38)
09:15 - 10:15 | Author(s): T.S.K. Mok
- Abstract
Abstract not provided
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No (ID 40)
09:15 - 10:15 | Author(s): F. Barlesi
- Abstract
- Presentation
Abstract not provided
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Second vote and conclusions (ID 41)
09:15 - 10:15 | Author(s): E. Smit
- Abstract
Abstract not provided
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Yes (ID 39)
09:15 - 10:15 | Author(s): D.P. Carbone
- Abstract
- Presentation
Abstract not provided
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Author of
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Liquid biopsies in NSCLC (ID 17)
- Event: ELCC 2017
- Type: Educational session
- Track:
- Presentations: 1
- Moderators:H. Wikman-Kocher, N. Normanno
- Coordinates: 5/06/2017, 14:45 - 16:15, Room A
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Role of cfDNA to monitor EGFR dynamic changes and resistance in blood (ID 71)
14:45 - 16:15 | Author(s): T.S.K. Mok
- Abstract
- Presentation
Abstract not provided
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Poster Display Session (ID 63)
- Event: ELCC 2017
- Type: Poster Display Session
- Track:
- Presentations: 2
- Moderators:
- Coordinates: 5/07/2017, 12:30 - 13:00, Hall 1
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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): T.S.K. Mok
- 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): T.S.K. Mok
- 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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Should we use newer generation targeted treatment upfront? (ID 10)
- Event: ELCC 2017
- Type: Controversy session
- Track:
- Presentations: 1
- Moderators:E. Smit, T.S.K. Mok
- Coordinates: 5/06/2017, 09:15 - 10:15, Room A
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Introduction and first vote (ID 38)
09:15 - 10:15 | Author(s): T.S.K. Mok
- Abstract
Abstract not provided
