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J. Soria



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    Immunotherapy of non-small cell lung cancer (ID 4)

    • Event: ELCC 2017
    • Type: Educational session
    • Track:
    • Presentations: 1
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      Toxicites of immuno-checkpoint blockers (ID 15)

      16:30 - 18:00  |  Author(s): J. Soria

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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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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      102P - LUX-Lung 8 phase III trial: Analysis of long-term response to second-line afatinib in patients with advanced squamous cell carcinoma (SCC) of the lung (ID 355)

      12:30 - 13:00  |  Author(s): J. Soria

      • Abstract

      Background:
      In LUX-Lung 8, afatinib (A; 40mg/day) significantly improved OS (median 7.9 vs 6.8 months, p = 0.008) and PFS (2.6 vs 1.9 months, p = 0.010) versus erlotinib (E; 150mg/day) in pts with pretreated SCC of the lung (n = 795). 12-month (36 vs 28%; p = 0.016) and 18-month survival (22 vs 14%; p = 0.013) were significantly higher with A than E, indicating that some pts derive prolonged benefit from A. This is a post-hoc analysis of baseline characteristics and efficacy/safety of A in long-term responders (LTRs; treatment for ≥12 months). Archived tumor samples and serum were analyzed to identify potential biomarkers.

      Methods:
      Tumor samples were retrospectively analyzed using next-generation sequencing (NGS); EGFR expression was determined by IHC. Pre-treatment serum samples were analyzed with VeriStrat[®] and classified as VeriStrat-Good or VeriStrat-Poor.

      Results:
      21/398 pts treated with A were LTRs. Six pts were still on treatment at the time of data cut-off. The median duration of treatment was 17.6 months (range: 12.3–27.6). Baseline characteristics were similar to the overall dataset (median age: 64 y [range: 54–81]; male: 76%; Asian: 29%; ECOG 0/1: 33%/67%; best response to chemotherapy CR or PR/SD: 48%/52%; current and ex-smokers: 90%). Median PFS was 16.6 months (range: 2.8–25.8); median OS was 21.1 months (12.9–31.6). The most common treatment-related AEs (all grade/grade 3) were: diarrhea (81%/5%); rash/acne (71%/5%); stomatitis (29%/5%). AEs generally occurred soon after treatment onset. Six pts had dose reductions due to related AEs. NGS data in ten LTRs will be presented. Genomic aberrations in the ErbB gene family were identified in 50% of these pts (overall dataset: 26.5%). Of 17 pts assessed by VeriStrat, 88% were VeriStrat-Good (overall dataset: 62%). IHC data were available for only one LTR (EGFR-).

      Conclusions:
      Baseline characteristics of LTRs to A were similar to the overall dataset. A conferred median OS of almost 2 years in this subgroup. A was well tolerated with predictable, transient AEs. Though biomarker data look promising, the cohort was too small to identify any clear NGS/VeriStrat predictive signals; further studies are required.

      Clinical trial identification:
      LUX-Lung 8: EudraCT No: 2011-002380-24

      Legal entity responsible for the study:
      Boehringer Ingelheim

      Funding:
      Boehringer Ingelheim

      Disclosure:
      J.C-H. Yang: Ad board and honoraria: BI, Lilly, Bayer, Roche/Genentech/Chugai, Astellas, MSD, Merck Serono, Pfizer, Novartis, Clovis, Celgene, Merrimack, Yuhan Pharmaceuticals, BMS, Ono pharmaceutical Daiichi, Sankyo, and AZ. G. Goss: Participated on advisory boards for AstraZeneca, Boehringer Ingelheim, Pfizer, Eli Lilly, Bristol-Myers Squibb, and Celgene. E. Felip: Participated on advisory boards for Eli Lilly, Pfizer, Roche, MSD, and Boehringer Ingelheim. Felip has receieved lecture fees from AstraZeneca, Bristol-Myers Squibb, and Novartis. A. Ardizzoni: Received honoraria and participated on advisory boards for Bristol-Myers Squibb, MSD, Eli-Lilly, and Boehringer Ingelheim. Ardizzoni has received honoraria from Pfizer and Bayer. S.M. Gadgeel: Participated on advisory boards for Boehringer Ingelheim, Pfizer, Genentech, ARIAD, AstraZeneca, Bristol-Myers Squibb, and Roche. N. Dupuis: Employee of and owns stock in Biodesix. E. Ehrnrooth: Employee of Boehringer Ingelheim. J-C. Soria: Astrazeneca, Astex, GSK, Gammamabs, Lilly, MSD, Merus, Pfizer, Pharmamar, Pierre Fabre, Roche, Sanofi, Servier, Symphogen, Takeda. All other authors have declared no conflicts of interest.

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    Targeted therapies and management of brain metastasis (ID 40)

    • Event: ELCC 2017
    • Type: Proffered Paper session
    • Track:
    • Presentations: 1
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      86O - Afatinib (A) plus cetuximab (C) in the treatment of patients (pts) with NSCLC: The story so far (ID 311)

      16:45 - 18:15  |  Author(s): J. Soria

      • Abstract
      • Presentation
      • Slides

      Background:
      Constitutive EGFR signalling due to activating mutations (e.g. EGFRm+ NSCLC) or overexpression (e.g. squamous (sq) NSCLC) is a common mechanism of tumourigenesis. There is biological rationale for combining A + C in tumours with unmet medical need, e.g. EGFRm+ NSCLC with resistance to EGFR-TKIs, and in advanced sqNSCLC. Preclinically, A + C improved anti-tumour activity in EGFRm+ NSCLC vs A or C alone. Here we report outcomes from two Phase Ib studies of A + C: NCT01090011 (study 1) in pts with EGFRm+ NSCLC resistant to gefitinib/erlotinib (G/E); and NCT02020577 (study 2) in unselected pts with heavily pretreated advanced solid tumours, including sqNSCLC.

      Methods:
      Study 1 comprised a dose-finding phase to identify the maximum tolerated dose (MTD) of A + C, and an expansion phase (EP) in which 126 pts received the MTD of A 40 mg/day + C 500 mg/m[2] Q2W. In study 2, 9 pts received A + C in a dose-escalation phase, and a further 49 pts received the MTD of A 40 mg/day + C 250 mg/m[2]/week in an EP, including 12 pts with sqNSCLC.

      Results:
      Drug-related adverse events (DR-AEs; all grades) were reported in 99% of pts in the EP of study 1 (n = 126), and 98% of pts in study 2 (n = 58). Grade 3/4/5 DR-AEs were experienced by 44%/2%/2% of pts in study 1 and 31%/3%/0% in study 2. DR-AEs led to discontinuation of treatment in 14% of pts in study 1 and 12% in study 2. Efficacy in pts with NSCLC is shown in the table. In the study 1 EP, ORR was 29% and median PFS was 4.7 months; there were no significant differences in ORR or median PFS in pts with T790M+ vs T790M- tumours (32 vs 25% [p = 0.341] and 4.6 vs 4.8 months [p = 0.643], respectively). Median duration of OR was 5.7 months. In the study 2 EP, 75% of pts with sqNSCLC had SD, and median PFS was 11.9 weeks.

      Conclusions:
      Based on the demonstrated antitumour activity and a predictable/manageable safety profile, A + C may be a treatment option in pts with EGFRm+ NSCLC and acquired resistance to G/E (irrespective of T790M status) or with pre-treated advanced sqNSCLC. rnTable: 86OEfficacy outcomesrn

      rnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrn rnrn
      TrialEGFRm+ NSCLCsqNSCLC
      Study 1 expansion phase[1] (n = 126)Study 2 expansion cohort[2] (n = 12)
      Disease control (CR/PR/SD), n (%)89 (71)9 (75)
      OR (CR/PR), n (%)37 (29)0
      SD52 (41)9 (75)
      Unconfirmed OR5 (4)–
      PD, n (%)27 (21)3 (25)
      Median duration of OR, months (range)5.7 (1.8–24.4)–
      Median duration of disease control, weeks (standard deviation)–17.9 (9.9)
      Median PFS (95% CI)4.7 months (4.3–6.4)11.9 weeks (5.1–19.4)
      rnCR, complete response; PR, partial response; SD, stable disease; PD, progressive disease;rnOR, objective response; PFS, progression-free survival 1. Janjigian YY, et al. Cancer Discov 2014;4:1036-45 2. Gazzah A, et al. Eur J Cancer 2016;68(Suppl. 1);S139:abstract 426rn

      Clinical trial identification:
      NIH study numbers: 1200.71: NCT01090011 1200.122: NCT02020577

      Legal entity responsible for the study:
      Boehringer Ingelheim

      Funding:
      Boehringer Ingelheim

      Disclosure:
      J-C. Soria: Astrazeneca, Astex, GSK, Gammamabs, Eli Lilly, MSD, Merus, Pfizer, Pharmamar, Pierre Fabre, Roche, Sanofi, Servier, Symphogen, Takeda. Y.Y. Janjigian: Employee of Memorial Sloan Kettering Cancer Center Advisory boards: ASCO GI Corporate-sponsored research: Merck, BMS Consultant: Pfizer Grant/research: BI, Bayer, Amgen, Genentech, Roche. H.J.M. Groen: Participated on advisory boards for Boehringer Ingelheim. W. Pao: Reports that patent rights on EGFR T790M were licensed by MSKCC to Molecular MD. J. Fan: Boehringer Ingelheim employee. M. Ould-Kaci: Employee of Boehringer Ingelheim. L. Horn: Consulting for AbbVie, BMS, Merck, Eli Lilly, Xcovery, Bayer. All other authors have declared no conflicts of interest.

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