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Julien Mazieres
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Lunch & Poster Display session (ID 58)
- Event: ELCC 2019
- Type: Poster Display session
- Track:
- Presentations: 2
- Moderators:
- Coordinates: 4/11/2019, 12:30 - 13:00, Hall 1
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179P - Treatment (tx) characteristics of patients (pts) with locally advanced or metastatic non-small cell lung cancer (NSCLC) receiving atezolizumab (atezo) monotherapy in US clinical practice (ID 227)
12:30 - 13:00 | Author(s): Julien Mazieres
- Abstract
Background
In the randomised Ph III OAK study, atezo (anti–PD-L1) significantly improved survival vs docetaxel, regardless of PD-L1 levels, and was approved by the FDA and EMA as 2L+ tx for advanced NSCLC. Given limited real-world data (RWD) on atezo in clinical practice, we describe here tx and characteristics of pts receiving atezo in clinical practice.
a9ded1e5ce5d75814730bb4caaf49419 Methods
Pts diagnosed with advanced NSCLC on or after Jan 1, 2011, and who initiated 2L+ atezo before Jul 1, 2017, were identified from the Flatiron Health database of electronic health records from US-based hospitals and community practices. Time-on-treatment (TOT) was defined as time from first to last atezo dose, plus 1 cycle. Median TOT was calculated using the Kaplan-Meier methods. Data from the OAK registrational trial (NCT02008227) are provided.
20c51b5f4e9aeb5334c90ff072e6f928 Results
122 pts met selection criteria (Table). 105 pts (86%) had 2L+ atezo without prior anti–PD-1 tx, while 17 pts (14%) had prior anti–PD-1 tx. Median TOT was 3.9 mo (95% CI: 2.9, 4.9), similar to OAK. A median of 4 cycles was administered for both non-squamous (IQR 1-22) and squamous (IQR 1-17) histology. Progression was the most common reason for atezo discontinuation.
fd69c5cf902969e6fb71d043085ddee6 Conclusions
TOT with atezo in the US RW setting was similar to the OAK clinical trial setting, although pts treated in RW were older and 22% had ≥ 3 lines of previous therapy.
b651e8a99c4375feb982b7c2cad376e9 Editorial acknowledgement
Medical writing assistance for this abstract was provided by Steffen Biechele, PhD, of Health Interactions and funded by F. Hoffmann-La Roche, Ltd.
934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study
F. Hoffmann-La Roche, Ltd.
213f68309caaa4ccc14d5f99789640ad Funding
F. Hoffmann-La Roche, Ltd.
682889d0a1d3b50267a69346a750433d Disclosure
M. Frueh: Consulting/advisory: BMS, MSD, AZ, BI, Roche; Research funding: MSD. O.E. Rahma: Advisory board: Celgene, Leerink, PRMA Couns., Outcomes4me, Puretech; Consulting: Alcimed SAS, GFK, Merck, Five Prime, Defined Health Honorarium: Merck, Clinical Care Option, Mi Bioresearch, Alaunusglobal; Other (study/editorial support): Roche. R.K. Pachynski: Grants/research support: Ferring, Janssen; Consultant: AZ, BMS, EMD Serono, Exelixis, Dendreon, Jounce, Pfizer; Speakers: AZ, GNE/Roche, Dendreon, Genomic Health, Sanofi, Merck; Other (support of parent study and funding of editorial support): Roche. J. Mazieres: Financial relationship: Roche, BMS, MSD, AstraZeneca, Pfizer, Novartis: consulting fees; Contracted research: Roche, BMS. J. Goldschmidt Jr.: Consulting/advisory role/honorarium: Amgen; Speakers bureau: BMS, Celgene; Support of parent study, funding of editorial support: Roche. T.G.N. Ton: Full time employee with self-managed stock: Genentech/Roche. S.K. Mhatre: Genentech, Inc./F. Hoffmann-La Roche: full time employee F. Hoffmann-La Roche: Stock shareholder (self managed) C-Y. Chuo: Full time employee, stock, support of parent study, funding of editorial support: Roche/Genentech. J. Martinalbo, J. Davies: Full time employee: F. Hoffmann-La Roche. R. Juergens: Honoraria: Amgen, AZ, BI, BMS, Lilly, Merck Sharp & Dohme, Roche Canada; Consulting or advisory role: Amgen, AZ, BI, BMS, Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Roche Canada; Research funding: AZ/MedImmune, BMS, Merck Sharp & Dohme, Novartis.
cffcb1a185b2d7d5c44e9dc785b6bb25 -
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182TiP - A phase II trial of tepotinib in patients with non-small cell lung cancer (NSCLC) harboring MET alterations: The VISION study (ID 452)
12:30 - 13:00 | Author(s): Julien Mazieres
- Abstract
Background
Dysregulation of the MET pathway is common in human carcinomas and leads to dependency on MET signalling, representing a potential therapeutic target in NSCLC. MET alterations including MET-exon 14 skipping mutations (METex14) and MET amplification (METamp) are known oncogenic drivers, and occur in 3–4% and 0.4–1.5% of NSCLCs, respectively. Tepotinib, a potent selective, small molecule MET inhibitor, has shown promise in preclinical and phase 1 trials.
a9ded1e5ce5d75814730bb4caaf49419 Trial design
VISION (NCT02864992), a single-arm, open-label, multicentre Phase 2 trial, will assess the antitumour activity and tolerability of tepotinib 500 mg daily, as 1st–3rd line of treatment, in patients with histologically-confirmed, advanced (stage IIIB/IV) NSCLC (all histologies) harboring MET alterations. Patients with METex14 + (determined by tumor biopsy [TBx] and/or plasma ‘liquid’ biopsy [LBx]; Cohort A) or METamp (determined by LBx; Cohort B) NSCLC are included. Prior treatment with checkpoint inhibitors is permitted. Patients with epidermal growth factor receptor-activating mutations, anaplastic lymphoma kinase rearrangements, or with brain metastasis as the only measurable lesion are excluded. The primary endpoint is objective response rate (ORR) by independent review committee via Response Evaluation Criteria in Solid Tumors v1.1. Secondary objectives include investigator-assessed ORR, duration of response, disease control, progression free survival, overall survival, tolerability, and safety. Adverse events (AEs) will be monitored throughout the study and for 30 days (90 days for serious AEs) after treatment and graded per National Cancer Institute Common Terminology Criteria for Adverse Events v4.0. Enrolment into Cohort A commenced in September 2016 and is continuing. Enrolment of patients with LBx-confirmed METamp into Cohort B commenced in September 2018; based on an interim analysis of 12 patients, recruitment may continue to enrol ≥60 patients. This abstract was previously presented at ESMO Asia 2018, FPN 546TiP, Paik et al. Reused with permission.
d9b324a48b043b3d87bc9b3fe620f260 Clinical trial identification
NCT02864992.
7a6a3ffa2dadc03a6151ee2c4d6fa383 Editorial acknowledgement
Medical writing assistance (funded by Merck KGaA, Darmstadt, Germany) was provided by Lisa Jolly, Bioscript Science (Macclesfield, UK).
934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study
Merck KGaA.
213f68309caaa4ccc14d5f99789640ad Funding
Merck KGaA.
682889d0a1d3b50267a69346a750433d Disclosure
P. Paik: Advisory board, honorarium: Celgene; IDMC: Takeda. A. Cortot: Advisory boards member: AstraZeneca, BMS, MSD, Pfizer, Novartis, Roche, Takeda, Boehringer Ingelheim; Corporate-sponsored research: Merck. E. Felip: Speaker’s bureau, advisory board: AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Celegene, Eli Lilly, Guardant Health, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Takeda, AbbVie, Merck. J. Mazieres: Advisory board: Roche, BMS, MSD, AstraZeneca, Pfizer, Novartis. F. Griesinger: Scientific support: ASTRA, Boehringer Ingelheim, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, Takeda, Siemens; Talks, presentations, advisory boards: ASTRA, Boehringer Ingelheim, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, Takeda, ARIAD, AbbVie, Siemens. R. Bruns, J. Scheele, J. Straub: Employee: Merck KGaA, Darmstadt, Germany. R. Veillon: Congress registration, advisory board: Boehringer Ingelheim, Bristol-Myers Squibb, Merck Sharp & Dohme, Roche, Pfizer, AbbVie, Merck. All other authors have declared no conflicts of interest.
cffcb1a185b2d7d5c44e9dc785b6bb25
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NSCLC stage IV oncogenic addicted disease (ID 9)
- Event: ELCC 2019
- Type: Educational session
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 4/10/2019, 16:30 - 18:00, Room B
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Immunotherapy in oncogenic addicted NSCLC (ID 23)
16:30 - 18:00 | Presenting Author(s): Julien Mazieres
- Abstract
- Presentation
Abstract not provided
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