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S. Peters
Moderator of
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Heine H. Hansen Award Lecture (ID 1)
- Event: ELCC 2017
- Type: Keynote Lecture
- Track:
- Presentations: 1
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The Heine Hansen legacy: How can we improve lung cancer research and practice? (ID 1)
13:45 - 14:15 | Author(s): R. Dziadziuszko
- Abstract
- Presentation
Abstract not provided
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Immunotherapy of non-small cell lung cancer (ID 4)
- Event: ELCC 2017
- Type: Educational session
- Track:
- Presentations: 4
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Biomarkers (ID 13)
16:50 - 17:10 | Author(s): K. Kerr
- Abstract
- Presentation
Abstract not provided
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Combination approaches (ID 14)
17:10 - 17:30 | Author(s): N. Rizvi
- Abstract
- Presentation
Abstract not provided
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First-line treatment (ID 12)
16:30 - 16:50 | Author(s): M. Reck
- Abstract
- Presentation
Abstract not provided
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Toxicites of immuno-checkpoint blockers (ID 15)
17:30 - 17:50 | Author(s): J. Soria
- Abstract
- Presentation
Abstract not provided
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Author of
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ESMO-IASLC Best Abstracts (ID 48)
- Event: ELCC 2017
- Type: Best abstracts session
- Track:
- Presentations: 1
- Moderators:A.G. Nicholson, M. Reck
- Coordinates: 5/07/2017, 16:45 - 18:15, Room B
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Invited Discussant 81O and 82O (ID 552)
17:15 - 17:30 | Author(s): S. Peters
- Abstract
Abstract not provided
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Immunotherapies and targeted therapies in advanced NSCLC (ID 39)
- Event: ELCC 2017
- Type: Proffered Paper session
- Track:
- Presentations: 1
- Moderators:L. Paz-Ares, N. Reguart
- Coordinates: 5/06/2017, 14:45 - 16:15, Room B
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84O - Atezolizumab as first-line (1L) therapy for advanced non-small cell lung cancer (NSCLC) in PD-L1–selected patients: Efficacy data from the BIRCH trial (ID 367)
15:00 - 15:15 | Author(s): S. Peters
- Abstract
Background:
Atezolizumab (atezo) inhibits binding of PD-L1 to its receptors, PD-1 and B7.1, restoring tumor-specific T-cell immunity and leaving the PD-L2/PD-1 interaction intact. This single-arm Phase II study (BIRCH; NCT02031458) was designed to evaluate atezo monotherapy in PD-L1–selected patients with advanced NSCLC. A previous analysis (median follow-up, 8.5 months) demonstrated clinical activity in chemotherapy-naive 1L and 2L+ PD-L1–selected patients. Here we present updated efficacy data for 1L patients.
Methods:
Eligible patients had PD-L1–selected advanced-stage NSCLC, with no prior chemotherapy or CNS metastases. PD-L1 was centrally evaluated using the VENTANA SP142 IHC assay. Enrolled patients expressed PD-L1 on ≥ 5% of tumor cells (TC) or tumor-infiltrating immune cells (IC), ie, TC2/3 or IC2/3. Those with EGFR mutation or ALK rearrangement must have had prior treatment with an appropriate TKI. Atezo was administered (1200 mg IV q3w) until radiographic disease progression or unacceptable toxicity. The primary endpoint was independent review facility (IRF)–assessed ORR; secondary endpoints included investigator (INV)-assessed ORR, DOR, PFS (RECIST v1.1) and OS.
Results:
With a median duration of survival follow-up of 22.5 months, INV-assessed ORR was 25% in TC2/3 or IC2/3 (all treated) patients and 34% in TC3 or IC3 patients (Table). Median OS was 23.5 months in all treated patients and 26.9 months in the TC3 or IC3 subgroup. Responses were observed in both EGFR and KRAS mutant and wild-type tumors. The safety profile was consistent with previous atezo NSCLC studies.
Conclusions:
With a median follow-up of 22.5 months, atezo continued to demonstrate durable clinical benefit in 1L NSCLC, in both EGFR and KRAS mutant and wild-type tumors. These results support ongoing Phase III trials evaluating atezo vs chemotherapy in 1L NSCLC.rnTable: 84Ornrn
rnNE, not estimable.rnaTC ≥ 50% or IC ≥ 10% PD-L1–expressing cells.rnbTC or IC ≥ 5% PD-L1–expressing cells.rnrn rnrnEndpoint (95% CI) rnTC3 or IC3[a] (n = 65) rnTC2/3 or IC2/3[b] (n = 138) rnrn rnINV ORR, % rn34% rn25% rnrn rn(22.6-46.7) rn(18.4-33.5) rnrn rnEGFR mutant/wild type, ORR, % rn25%/31% rn31%/22% rnrn rnKRAS mutant/wild type, ORR, % rn38%/30% rn31%/22% rnrn rnMedian DOR, mo rnNE rn16.5 rnrn rn(8.5-NE) rn(9.9-NE) rnrn rnMedian OS, mo rn26.9 rn23.5 rnrn rn(12.0-NE) rn(18.1-NE) rnrn rn12-mo OS rate, % rn61.5% rn66.4% rnrn rn(49.0-74.0) rn(58.1-74.6) rnrn rnMedian PFS, mo rn7.3 rn7.3 rnrn rn(4.9-12.0) rn(5.7-9.7) rnrn rn12-mo PFS rate, % rn36.5% rn32.5% rnrn rnrn(24.0-48.9) rn(24.2-40.8) rn
Clinical trial identification:
NCT02031458
Legal entity responsible for the study:
F. Hoffmann-La Roche Ltd/Genentech Inc., a member of the Roche Group
Funding:
F. Hoffmann-La Roche Ltd/Genentech Inc, a member of the Roche Group
Disclosure:
M.C. Garassino: Honoraria, Consulting, Speaker\'s Bureau, research funding, expert testimony, travel expenses: MSD, BMS, AZ, Lilly, Roche. D. Christoph: Honoraria, Speaker\'s Bureau: BI, BMS, Chugai, Novartis, Merck, MSD, Pfizer, Roche; Consulting: BI, BMS, Novartis, Pfizer, Roche; Expert testimony: BI, BMS, Novartis, Pfizer, Roche. J. Chaft: Advisor for Genentech and Astra Zeneca. M.L. Johnson: Consulting: Genentech, Celgene, BI; Research funding: OncoMed, BerGenBio, Lilly, EMD Serono, Kadmon, Janssen, Mirati, Genmab, Pfizer, AZ, Roche/Genentech, Stemcentrix, Novartis, Checkpoint, Array, Regeneron. S. Mocci: Employee, stock: Roche/Genentech. S.N. Gettinger: Consulting: BMS; Research funding: Roche/Genentech, BMS, ARIAD, Incyte, Celldex. E. Felip: Advisory Boards: Lilly, Pfizer, BI, MSD, Roche; Speaker\'s Bureau: AZ, BMS, Novartis. All other authors have declared no conflicts of interest.
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Immunotherapy for other thoracic tumours (ID 8)
- Event: ELCC 2017
- Type: Educational session
- Track:
- Presentations: 1
- Moderators:S. Popat, G. Giaccone
- Coordinates: 5/06/2017, 09:00 - 10:30, Room B
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Perspectives in SCLC (ID 28)
09:00 - 09:20 | Author(s): S. Peters
- Abstract
Abstract not provided
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Industry Satellite Symposium 6 (ID 57)
- Event: ELCC 2017
- Type: Industry Satellite Symposium
- Track:
- Presentations: 1
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Poster Display Session (ID 63)
- Event: ELCC 2017
- Type: Poster Display Session
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 5/07/2017, 12:30 - 13:00, Hall 1
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80TiP - A feasibility trial evaluating the addition of nivolumab to standard first-line chemo-radiotherapy in locally advanced stage IIIA/B NSCLC: The ETOP 6-14 NICOLAS trial (ID 455)
12:30 - 12:30 | Author(s): S. Peters
- Abstract
Background:
Sequential or concomitant chemo-radiotherapy is the treatment of choice for stage III NSCLC. One attempt to improve the long-term survival is an immunotherapeutic strategy. The monoclonal antibody nivolumab targets and inhibits PD-1, an immune receptor on activated T-cells and responsible for abrogating anti-cancer immune response. The role of immune-checkpoint inhibitors is currently being evaluated in this indication as monotherapy or in combination with chemotherapy as well as after completion of chemo-radiotherapy but it has not yet been assessed in combination with radiotherapy. While anecdotal data of concurrent therapy suggests an acceptable toxicity profile, a formal prospective assessment is required before embarking on trials comparing concurrent versus sequential checkpoint inhibitors and radiotherapy.
Trial design:
NICOLAS is a phase II feasibility trial evaluating the administration of nivolumab concomitantly with standard first-line chemo-radiotherapy for locally advanced stage IIIA/B NSCLC. Additional inclusion criteria include adequate organ function and performance status 0-1. Chemotherapy consists of three cycles of cisplatin plus vinorelbine, etoposide or pemetrexed. Radiotherapy to the chest will be delivered either sequentially to or concurrently with chemotherapy. The initial nivolumab dose is 240 mg Q2W for eight cycles in the sequential, and 360 mg Q3W for four cycles in the concurrent chemo-radiotherapy schedule, followed by 480 mg Q4W for maximum one year for both regimens. A total of 43 patients will be recruited into the trial. The primary endpoint is grade > =3 pneumonitis observed up to 6 months after radiotherapy. The goal is to reject a 6-month pneumonitis-free rate of < =67%, tested at a rate of 85%, with 85% power and 5% one-sided alpha. An interim analysis will be performed after 21 patients have completed a 3-month follow-up on nivolumab treatment. Safety is closely monitored by the ETOP IDMC at their regular meetings every three months. NICOLAS is sponsored by ETOP with financial support of Bristol-Meyers Squibb. Accrual is ongoing and as of January 2017, 18 patients have been enrolled.
Clinical trial identification:
EudraCT: 2014-005097-11
Legal entity responsible for the study:
European Thoracic Oncology Platform (ETOP)
Funding:
Bristol-Meyers Squibb
Disclosure:
R.A. Stahel: Honoraria as consultant at advisory boards from Abbvie, Astra Zeneca, BMS, Boehringer Ingelheim, Eli Lilly, MSD, Pfizer and Roche and as speaker from Astellas, Astra Zeneca, Lilly, MSD, Novartis and Roche. R.M. Huber: Honoraria as consultant at advisory boards from BMS. All other authors have declared no conflicts of interest.
