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F. Barlesi

Moderator of

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    How can we optimise our organisation to deliver precision oncology? (ID 18)

    • Event: ELCC 2018
    • Type: Educational session
    • Track:
    • Presentations: 4
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      Access to personalised medicine (ID 74)

      16:45 - 18:15  |  Presenting Author(s): P. Garrido Lopez

      • Abstract
      • Presentation
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      Abstract not provided

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      Organisational models for biomarkers testing (ID 73)

      16:45 - 18:15  |  Presenting Author(s): S. Popat

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      Abstract not provided

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      The pathologist’s point of view (ID 75)

      16:45 - 18:15  |  Presenting Author(s): F. Lopez-Rios

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      Abstract not provided

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      The patient’s point of view (ID 76)

      16:45 - 18:15  |  Presenting Author(s): S. Novello

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    Liquid biopsy at the initial diagnosis and during monitoring (ID 20)

    • Event: ELCC 2018
    • Type: Multidisciplinary Interactive Session (MIS)
    • Track:
    • Presentations: 2
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      Diagnosis and monitoring with liquid biopsy for targeted treatment (ID 82)

      08:00 - 08:50  |  Presenting Author(s): F. Barlesi

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      Abstract not provided

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      Which technology can we use? CTCs vs ctDNA (ID 81)

      08:00 - 08:50  |  Presenting Author(s): M. Denis

      • Abstract
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      Abstract not provided

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Author of

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    HHH Award Keynote Lecture (ID 1)

    • Event: ELCC 2018
    • Type: Keynote Lecture
    • Track:
    • Presentations: 1
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      The power of the multiple H (ID 1)

      13:45 - 14:15  |  Presenting Author(s): F. Barlesi

      • Abstract
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      Abstract not provided

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    Immunotherapy and next-generation TKIs: From second to frontline treatment (ID 55)

    • Event: ELCC 2018
    • Type: Poster Discussion session
    • Track:
    • Presentations: 1
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      134PD - Primary PFS and safety analyses of a randomized phase III study of carboplatin + paclitaxel +/− bevacizumab, with or without atezolizumab in 1L non-squamous metastatic NSCLC (IMpower150) (ID 469)

      07:45 - 09:00  |  Author(s): F. Barlesi

      • Abstract
      • Slides

      Background:
      Atezolizumab (atezo; anti–PD-L1) inhibits PD-L1 binding to PD-1 and B7.1, restoring anti-cancer immunity. Bevacizumab (bev) may further enhance atezo efficacy by inhibiting VEGF immunosuppression and promoting T-cell tumour infiltration. IMpower150 evaluates the addition of atezo to carboplatin (C) + paclitaxel (P) ± bev in chemo-naive patients (pts) with non-squamous (NSQ) mNSCLC.

      Methods:
      1202 pts received atezo 1200 mg + C AUC 6 + P 200 mg/m[2] (Arm A) or atezo + bev 15 mg/kg + C + P (Arm B) vs bev + C + P (Arm C) IV q3w for 4 or 6 cycles per investigator (INV) discretion, then maintenance atezo, atezo + bev or bev, respectively. Co-primary endpoints assessed at this data cutoff (15 Sep 2017; minimum follow up, 9.5 mo) were INV-assessed PFS in the ITT-WT (EGFR or ALK negative) population and in WT pts with expression of a tumour T-effector gene signature (Teff-WT; centrally assessed), and OS in the ITT-WT population, for the Arm B vs Arm C comparison. Due to pre-specified statistical testing hierarchy, Arm A vs Arm C has not been formally tested yet.

      Results:
      356 pts in Arm B and 336 pts in Arm C were enrolled in the ITT-WT. Median age was 63 y; 60% were previous smokers (both arms). 61% and 62% were male, and 39% and 43% had ECOG PS 0 in Arms B and C, respectively. The HRs for INV-assessed PFS in Arm B vs C were 0.62 (95% CI: 0.52, 0.74; P < 0.0001) in the ITT-WT and 0.51 (0.38, 0.68; P < 0.0001) in the Teff-WT populations. Median PFS in Arm B vs C was 8.3 mo vs 6.8 mo and 11.3 mo vs 6.8 mo in the ITT-WT and Teff-WT populations, respectively. PFS benefit was seen regardless of PD-L1 IHC status, including PD-L1–negative pts (TC0/IC0; HR, 0.77 [95% CI: 0.61, 0.99]). Landmark PFS and ORR are shown (Table). Arm B had a comparable safety profile to Arm C; treatment-related serious AEs were 25% vs 19%, respectively.Table:IMpower150 Primary PFS Analysis, Landmark PFS and ORR

      Arm C (bev + C + P; N = 400)Arm B (atezo + bev + C + P; N = 400)
      ITT-WT population[a]n = 336n = 356
      Median PFS (95% CI), mo6.8 (6.0, 7.1)8.3 (7.7, 9.8)
       HR (95% CI; P value)0.62 (0.52, 0.74; P < 0.0001)
      ITT-WT landmark PFS (95% CI), %
       6-month56% (51, 62)67% (62, 72)
       12-month18% (13, 23)37% (31, 42)
      ORR[b,c] (95% CI), %48% (43, 54)64% (58, 68)
      Teff-WT population[a]n = 129n = 155
      Median PFS (95% CI), mo6.8 (5.9, 7.4)11.3 (9.1, 13.0)
       HR (95% CI; P value)0.51 (0.38, 0.68; P < 0.0001)
      Teff-WT landmark PFS (95% CI), %
       6-month57% (48, 66)72% (65, 79)
       12-month18% (10, 25)46% (38, 54)
      ORR[b,d] (95% CI), %54% (44, 62)69% (61, 76)
      HR, hazard ratio; ORR, objective response rate; PFS, progression-free survival; Teff, T-effector; WT, wild-type.aWT populations exclude patients with EGFR or ALK driver mutations.bUnconfirmed ORR.cn = 353 in Arm B and n = 331 in Arm C.dn = 153 in Arm B and n = 127 in Arm C.

      Conclusions:
      IMpower150 is the first Phase III study to show a statistically significant and clinically meaningful PFS benefit with atezo + bev + chemo vs bev + chemo in pts with 1L NSQ mNSCLC. Acknowledgement of contribution: G. Finley (Allegheny Cancer Center, Pittsburgh, PA, USA), R. Jotte (Rocky Mountain Cancer Centers, Denver, CO, USA), C. Kelsch, A. Lee, S. Coleman, Y. Shen, M. Kowanetz, A. Lopez-Chavez, A. Sandler (Genentech, Inc., South San Francisco, CA, USA).

      Clinical trial identification:
      NCT02366143

      Legal entity responsible for the study:
      F. Hoffmann-La Roche Ltd/Genentech, Inc

      Funding:
      F. Hoffmann-La Roche Ltd/Genentech, Inc

      Disclosure:
      M. Reck: Consulting or Advisory Role: Lilly, F.Hoffmann‐La Roche, BI, BMS, MSD, AstraZeneca, Merck, Novartis, Pfizer, Celgene. Speakers’ Bureau: F. Hoffmann‐La Roche, Lilly, Pfizer, BI, AstraZeneca, MSD, BMS, Merck, Novartis, Pfizer, Celgene. M. A. Socinski: Honoraria: Genentech, Speakers Bureau: Genentech, Research Funding: Genentech. F. Cappuzzo: Participation in advisory boards for Roche, AZ, BMS, Takeda, MSD, Lilly, Pfizer. F. Orlandi: Research grants from Astrazeneca, MSD, Genetech-Roche, Advisory tasks for AstraZeneca, Roche, Boehringer Ingelheim, Pfizer. N. Nogami: Honoraria: Meiji Seika Pharma Co., Ltd., AstraZeneca, Pfizer Inc., Bristol‐Myers Squibb, ONO Pharmaceutical CO., LTD., Kyowa Hakko Kirin, Taiho Phamaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd, Eli Lilly Japan, Boehringer Ingelheim. D. Rodríguez-Abreu: Honoraria for lectures and Advisory Board from Bristol-Myers-Squibb, Merck Sharp & Dohme and Hoffmann-La Roche. D. Moro-Sibilot: Advisory boards for Roche, MSD, Pfizer, Novartis, BMS, Astra Zeneca, Lilly. F. Barlesi: Honarium from Genentech & Roche. G. Finley: Promotional speaking on behalf of Bristol Meyers, Boehringer Ingleheim, and Astellas Medivation, and Merck. C. Kelsch: Genentech Employee with Roche Stock. A. Lee: Genentech Employee with Roche Stock. S. Coleman: Genentech Employee with Roche Stock. Y. Shen: Genentech Employee with Roche Stock. M. Kowanetz: Genentech Employee with Roche Stock. A. Lopez-Chavez: Genentech Employee with Roche Stock. A. Sandler: Genentech Employee with Roche Stock. All other authors have declared no conflicts of interest.

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    Liquid biopsy at the initial diagnosis and during monitoring (ID 20)

    • Event: ELCC 2018
    • Type: Multidisciplinary Interactive Session (MIS)
    • Track:
    • Presentations: 1
    • +

      Diagnosis and monitoring with liquid biopsy for targeted treatment (ID 82)

      08:00 - 08:50  |  Presenting Author(s): F. Barlesi

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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    New approaches in rare thoracic tumors (ID 60)

    • Event: ELCC 2018
    • Type: Proffered Paper session
    • Track:
    • Presentations: 1
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      135O - A phase 1b study of necitumumab in combination with abemaciclib in patients with stage IV non-small cell lung cancer (ID 592)

      11:00 - 12:30  |  Author(s): F. Barlesi

      • Abstract
      • Presentation
      • Slides

      Background:
      Necitumumab and abemaciclib inhibit tumor progression by different, independent mechanisms, and both have shown activity in patients with non-small cell lung cancer (NSCLC).

      Methods:
      This Phase 1b study was a single arm, multicenter trial to explore the safety and efficacy of necitumumab plus abemaciclib in adults with confirmed Stage IV NSCLC, who had received a maximum of 1 other prior chemotherapy for advanced and/or metastatic disease. Part A was a dose escalation study for abemaciclib in combination with necitumumab 800 mg D1D8 Q3W in up to 18 patients to determine the recommended dose for the expansion cohort (Part B, planned for 50 patients). The primary endpoint was progression-free survival (PFS) rate at 3 months compared to the historical PFS rate with single agent epidermal growth factor receptor inhibitors (50%). Secondary efficacy endpoints included PFS, overall response rate (ORR), disease control rate (DCR), and overall survival (OS).

      Results:
      Sixty-six patients entered the study: 71% male, 61% <65 years of age, 77% ECOG performance status 1, 41% squamous histology, and 15% never smokers. In Part A (n = 15), the maximum tolerated abemaciclib dose was determined to be 150 mg every 12 hours; overall 57 patients received this treatment. The 3-month PFS rate was 32.3% (95% CI: 20.4, 44.8); median PFS was 2.14 months (1.41, 2.76). ORR was 5.3% (1.1, 14.6), and DCR was 47.4% (34.0, 61.0). The median OS was 6.93 months (4.96, 12.85). Treatment-emergent adverse events occurring in ≥30% of all patients (n [%]) included fatigue (34 [51.5]), diarrhea (33 [50.0]), dermatitis acneiform (31 [47.0]), decreased appetite (26 [39.4]), nausea (26 [39.4]), anemia (24 [36.4]), dyspnea (22 [33.3]), hypomagnesemia (21 [31.8]), vomiting (21 [31.8]), and dry skin (20 [30.3]).

      Conclusions:
      In patients with Stage IV NSCLC, the combination of abemaciclib with necitumumab did not meaningfully impact the PFS rate at 3 months. The safety profile was consistent with the individual study drugs, and no new significant safety concerns emerged.

      Clinical trial identification:
      ClinicalTrials.gov NCT02411591

      Legal entity responsible for the study:
      Eli Lilly and Company

      Funding:
      Eli Lilly and Company

      Disclosure:
      B. Besse: Research support from Eli Lilly and Company. B. Frimodt-Moller, M. Gil: Employee and stockholder of Eli Lilly and Company. All other authors have declared no conflicts of interest.

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