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Raffaele Califano



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    Current management of early stage NSCLC (ID 6)

    • Event: ELCC 2019
    • Type: Educational session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/10/2019, 14:30 - 16:00, Room A
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      Current treatment approaches in early disease (ID 7)

      14:30 - 16:00  |  Presenting Author(s): Raffaele Califano

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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    ESMO Colloquium supported by Lilly Oncology in collaboration with MSD - How to best use immune checkpoint inhibitors in NSCLC: Single agents or combined with chemotherapy? (ID 56)

    • Event: ELCC 2019
    • Type: ESMO Colloquium
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/10/2019, 04:45 - 06:15, Room A
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      First-line immunotherapy options for patients without an oncogene driver (ID 661)

      04:45 - 06:15  |  Presenting Author(s): Raffaele Califano

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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    Lunch & Poster Display session (ID 58)

    • Event: ELCC 2019
    • Type: Poster Display session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/11/2019, 12:30 - 13:00, Hall 1
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      66P - Treatment (tx) characteristics and clinical outcomes in patients (pts) with extensive-stage small cell lung cancer (ES-SCLC) treated with carboplatin (carbo) or cisplatin (cis) in combination with etoposide (etop) in US clinical practice (ID 309)

      12:30 - 13:00  |  Author(s): Raffaele Califano

      • Abstract
      • Slides

      Background

      For pts with ES-SCLC, guidelines recommend carbo or cis + etop as first-line (1L) tx. However, real-world data (RWD) on tx patterns and outcomes are limited. Here, we describe pt characteristics, tx duration and clinical outcomes associated with these 2 regimens.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      Pts with ES-SCLC diagnosis (or limited-stage [LS] SCLC who initiated second-line [2L] tx) between 1 Jan 2013 and 31 Aug 2017 (follow-up to 31 Aug 2018) were identified from the US-based Flatiron Health electronic health record–derived database. Pts receiving tx with either carbo + etop or cis + etop were included in the analysis.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      RWD on 2161 pts from 156 tx centres were included; 84% of pts received carbo + etop. See table below for pt characteristics. The median tx duration was 3.4 mo (95% CI: 3.4, 3.4) with carbo + etop and 3.0 mo (95% CI: 2.8, 3.4) with cis + etop. The distribution of tx cycles administered was similar between carbo and cis, with 20% and 28% of pts completing 4 or 6 cycles, respectively. Median overall survival (OS) was 8.3 mo (95% CI: 8.1, 8.7) with carbo + etop and 9.7 mo (95% CI: 9.3, 11.0) with cis + etop. The 1-yr OS rates were 30% (95% CI: 28, 33) and 41% (95% CI: 36, 47), respectively. In pts with Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 and ≥ 2, median OS was 9.3 mo (95% CI: 8.6, 9.9) and 7.1 mo (95% CI: 6.3, 8.3), respectively. Pts with unknown ECOG PS had a median OS of 8.4 mo (95% CI: 8.0, 8.9).

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      Tx duration was similar between the 2 regimens. Pts who received cis + etop had numerically increased OS vs pts who received carbo + etop, as did pts with ECOG PS 0-1. However, these findings may be due to pts receiving cis + etop being fitter (younger and lower ECOG PS) at baseline.

      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. Sebastian: Honoraria, consulting: AZ, BI, BMS, Eli Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Roche; Honoraria: Pierre Fabre; Consulting: Celgene. F. Barlesi: Personal fees/clinical trials (inst.): AZ, BMS, BI, Lilly, Roche, Novartis, Merck, MSD, Pierre Fabre, Pfizer, Takeda; Clinical trials (inst.): AbbVie, ACEA, Amgen, Bayer, Eisai, Genentech, Ipsen, Ignyta, Innate Pharma, Loxo, Medimmune, Sanofi-Aventis. R. Califano: Honoraria/consult: BI; Stock: Christie Private Care; Grants/nonremunerated activities: Clovis, AbbVie; Leadership (nonrem): ESMO; Nonrem membership: EORTC; Honoraria/consult/grants/nonrem activities: AZ, Roche, Pfizer, Lilly, MSD, Takeda, Novartis, BMS. A.S. Mansfield: Research funding (inst.): Novartis, Verily; Honoraria/Ad board (inst.): Genentech, AbbVie, BMS Mesothelioma Applied Research Foundation; Board member (non-rem.) ASCO; Lung Cancer Education Committee member (non-rem). F.H. Blackhall: Grant/research: Roche, BI, AZ, Cellmedica, AbbVie, Pfizer; Advisory board: AZ, Cellmedica, AbbVie, Ipsen, Takeda, Roche; Consulting/speakers: Takeda; Honoraria: Takeda, Roche, AbbVie, Ipsen; Study, editorial support: Roche. E.M. Flahavan: Employee: Roche; Stock: Lilly, Roche; support of parent study and funding of editorial support: Roche. J. Davies: Employee: Roche. P. Arnold: Employee: Roche; Stock: Novartis Pharma AG. S. Morris: Employee, Stock: Roche. M. Reck: Support of parent study, funding of editorial support: Roche; Honoraria for lectures and consulting: Amgen, AbbVie, BI, BMS, Celgene, Merck-Serono, MSD, Lilly, Novartis, Pfizer, Roche.

      Characteristics

      Carbo + EtopCis + Etop
      Pts, n1815346
      Age, median (IQR), y68 (61-74)64 (58-69)
       35-64, n (%)663 (37)189 (55)
       65-69, n (%)357 (20)77 (22)
       ≥ 70, n (%)795 (44)80 (23)
      Male, n (%)919 (51)184 (53)
      White race, n (%)1383 (76)259 (75)
      Baseline ECOG PS, n (%)
       0-1716 (39)144 (42)
       ≥ 2296 (16)29 (8)
       Not provided803 (44)173 (50)
      Type of ES-SCLC, n (%)
       1L tx of ES-SCLC1757 (97)335 (97)
       2L tx of LS-SCLC58 (3)11 (3)

      IQR, interquartile range.

      cffcb1a185b2d7d5c44e9dc785b6bb25

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    Medscape Oncology - Industry Satellite Symposium (ID 28)

    • Event: ELCC 2019
    • Type: Industry Satellite symposium
    • Track:
    • Presentations: 2
    • Moderators:
    • Coordinates: 4/11/2019, 18:00 - 19:00, Room C
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      Case challenge 2: Second-line treatment selection - How do we choose? (ID 635)

      18:00 - 19:00  |  Presenting Author(s): Raffaele Califano

      • Abstract

      Abstract not provided

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      Testing for ALK-positive disease: The state of the art (ID 633)

      18:00 - 19:00  |  Presenting Author(s): Raffaele Califano

      • Abstract

      Abstract not provided

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    Proffered Paper session III (ID 64)

    • Event: ELCC 2019
    • Type: Proffered Paper session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/12/2019, 08:30 - 10:00, Room A
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      106O - Brigatinib (BRG) vs crizotinib (CRZ) in the phase III ALTA-1L trial (ID 166)

      08:30 - 10:00  |  Presenting Author(s): Raffaele Califano

      • Abstract
      • Presentation
      • Slides

      Background

      We report results of the first interim analysis (IA) from the ALTA-1L study of BRG vs CRZ in anaplastic lymphoma kinase (ALK) inhibitor–naive, ALK-positive non–small cell lung cancer (ALK+ NSCLC; NCT02737501).

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      This open-label, multicenter study enrolled patients (pts) with advanced ALK+ NSCLC. Eligible pts had ≤1 prior systemic therapy for advanced NSCLC. Asymptomatic central nervous system (CNS) metastases were allowed. Pts were randomized 1:1 to BRG 180 mg QD with 7-day lead-in at 90 mg or CRZ 250 mg BID. Primary endpoint was blinded independent review committee (BIRC)-assessed progression-free survival (PFS; RECIST v1.1); secondary efficacy endpoints included BIRC-assessed objective response rate (ORR), intracranial ORR (iORR), and intracranial PFS (iPFS). IAs were planned at 50% and 75% of 198 expected PFS events.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      275 pts were randomized (BRG/CRZ, n = 137/138); median age (years) 58/60. 26%/27% received prior chemotherapy for advanced disease, and 29%/30% had baseline brain metastases. At data cutoff (19 Feb 2018), with a median follow-up of 11.0/9.3 months (BRG/CRZ) and 99 PFS events, BRG met the prespecified threshold for statistical superiority vs CRZ in the primary endpoint of BIRC-assessed PFS (HR 0.49; 95% CI, 0.33–0.74; log-rank P = 0.0007); BRG median PFS was not reached (NR; 95% CI, NR) vs CRZ 9.8 months (95% CI, 9.0–12.9). Investigator-assessed PFS HR 0.45 (95% CI, 0.30–0.68); log-rank P = 0.0001. Table shows additional efficacy data. Most common grade ≥3 treatment-emergent adverse events (AEs): BRG: increased blood creatine phosphokinase (16.2%) and lipase (13.2%), hypertension (9.6%); CRZ: increased alanine aminotransferase (9.5%), aspartate aminotransferase (5.8%), and lipase (5.1%). Any grade interstitial lung disease/pneumonitis: BRG, 3.7%; CRZ, 2.2%. Discontinuations due to AE (BRG/CRZ): 11.8%/8.8%.

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      BRG showed a statistically and clinically significant improvement in PFS vs CRZ in ALK inhibitor–naive ALK+ NSCLC.

      b651e8a99c4375feb982b7c2cad376e9 Clinical trial identification

      NCT02737501.

      7a6a3ffa2dadc03a6151ee2c4d6fa383 Editorial acknowledgement

      Professional medical writing assistance was provided by Lauren Gallagher, PhD, (Peloton Advantage, Parsippany, NJ) and funded by Millennium Pharmaceuticals, Inc.

      934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study

      ARIAD Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.

      213f68309caaa4ccc14d5f99789640ad Funding

      ARIAD Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.

      682889d0a1d3b50267a69346a750433d Disclosure

      R. Califano: Honoraria, consulting/advisory role: AstraZeneca, BMS, Roche, MSD, Boehringer Ingelheim, Takeda, Novartis, Pfizer, Lilly Oncology. C. Gridelli: Speakers bureau, advisory role: Pfizer, Roche. A. Delmonte: Consulting/advisory role: AstraZeneca, Boehringer Ingelheim. M.R. Garcia Campelo: Honoraria: ARIAD, AstraZeneca, Roche, Pfizer, BMS, Boehringer Ingelheim; Speakers bureau, advisory role: ARIAD, AstraZeneca, Roche, Pfizer, BMS, Boehringer Ingelheim. A. Bearz: Speakers bureau, advisory role: AstraZeneca, Pfizer, Eli Lilly, BMS, Novartis, Roche, MSD, Boehringer Ingelheim, Takeda. F. Griesinger: Research funding to institution: AstraZeneca, Boehringer Ingelheim, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, Takeda, Siemens; Consulting or advisory role: ARIAD, AstraZeneca, Boehringer Ingelheim, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, Takeda, ARIAD, AbbVie, Siemens. E. Felip: Consulting/advisory role: AbbVie, AstraZeneca, Blue Print Medicines, Boehringer Ingelheim, BMS, Celgene, Eli Lilly, Guardant Health, Janssen, Merck KGaA, MSD, Novartis, Pfizer, Roche, Takeda; Speakers bureau: AbbVie, AstraZeneca, Boehringer Ingelheim, BMS, Eli Lilly, Merck KGaA, MSD, Novartis, Pfizer, Roche, Takeda. S. Popat: Research funding to institution: Boehringer Ingelheim, Epizyme, BMS, Clovis Oncology, Roche, Lilly, Takeda; Honoraria: Boehringer Ingelheim, AstraZeneca, Roche, Takeda, Chugai Pharma; Consulting or advisory role: Boehringer Ingelheim, Roche, Novartis, Pfizer, AstraZeneca, BMS, MSD, Guardant Health, AbbVie; Travel, accommodations, expenses: Boehringer Ingelheim, BMS, Merck Sharp & Dohme. A. Morabito: Honoraria: AstraZeneca, Roche, Boehringer Ingelheim, Pfizer, MSD, BMS. S. Ghosh: Honoraria/speakers bureau: Pfizer. M. Tiseo: Speakers bureau, advisory role: AstraZeneca, BMS, Boehringer Ingelheim, Eli Lilly, MSD, Novartis, Otsuka, Pfizer, Pierre Fabre, Roche. J. Haney, D. Kerstein: Employment, stock and other ownership interests: Arîad. D.R. Camidge: Honoraria: AstraZeneca, Takeda, Arrys/Kyn, Genoptix, G1 Therapeutics (DSMB), Mersana Therapeutics, Roche/Genentech, Ignyta, Daichii Sankyo (ILD adjudication committee), Hansoh SRC, Bio-Thera DSMB, Lycera, Revolution Med, Orion, Clovis, Celgene, Novartis); Research funding (ARIAD/Takeda). All other authors have declared no conflicts of interest.

      cffcb1a185b2d7d5c44e9dc785b6bb25

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