Virtual Library

Start Your Search

Solange Peters



Author of

  • +

    Bristol-Myers Squibb - Industry Satellite Symposium (ID 11)

    • Event: ELCC 2019
    • Type: Industry Satellite symposium
    • Track:
    • Presentations: 4
    • Moderators:
    • Coordinates: 4/10/2019, 18:15 - 19:15, Room A
    • +

      Clinical practice today and future considerations (ID 618)

      18:15 - 19:15  |  Presenting Author(s): Solange Peters

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

      Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.

      Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.

    • +

      Closing remarks and audience Q&A (ID 620)

      18:15 - 19:15  |  Presenting Author(s): Solange Peters

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

      Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.

      Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.

    • +

      Moderator (ID 730)

      18:15 - 19:15  |  Presenting Author(s): Solange Peters

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

      Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.

      Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.

    • +

      Welcome and introductions (ID 617)

      18:15 - 19:15  |  Presenting Author(s): Solange Peters

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

      Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.

      Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.

  • +

    Do we treat patients with I-O until progression? (ID 45)

    • Event: ELCC 2019
    • Type: Controversy session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/13/2019, 08:30 - 09:30, Room C
    • +

      Introduction and first vote (ID 108)

      08:30 - 09:30  |  Presenting Author(s): Solange Peters

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

      Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.

      Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.

  • +

    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
    • +

      Are immune checkpoints (ICPs) better as single agent, doublet ICPs or combined with chemo +/- anti-angiogenics? (ID 663)

      04:45 - 06:15  |  Presenting Author(s): Solange Peters

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

      Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.

      Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.

  • +

    ESMO-IASLC Best Abstracts (ID 62)

    • Event: ELCC 2019
    • Type: Proffered Paper session
    • Track:
    • Presentations: 2
    • Moderators:
    • Coordinates: 4/11/2019, 14:45 - 16:15, Room B
    • +

      LBA1_PR - Nivolumab (nivo) plus ipilimumab (ipi), nivo, or placebo (pbo) as maintenance therapy in patients (pts) with extensive disease small cell lung cancer (ED-SCLC) after first-line (1L) platinum-based chemotherapy (chemo): Results from the double-blind, randomized phase III CheckMate 451 study (ID 683)

      14:45 - 16:15  |  Author(s): Solange Peters

      • Abstract
      • Presentation
      • Slides

      Background

      In pts with ED-SCLC, response rates to 1L platinum-based chemo are high but lack durability. Treatments (txs) that prolong response duration and improve survival are needed. CheckMate 451 (NCT02538666) is a global, double-blind, phase 3 study of nivo+ipi or nivo vs pbo as maintenance therapy in pts with ED-SCLC who did not progress on 1L platinum-based chemo.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      Pts (N = 834) with ED-SCLC, ECOG performance status (PS) ≤ 1 and response or stable disease after 4 cycles of 1L platinum-based chemo were randomized 1:1:1 (3–9 weeks from last dose of 1L chemo or 3–11 weeks for pts who received prophylactic cranial irradiation [PCI]) to nivo 1 mg/kg + ipi 3 mg/kg Q3W intravenously (IV; 4 doses followed by nivo 240 mg Q2W IV; n = 279), nivo 240 mg Q2W IV (n = 280), or pbo (n = 275), stratified by PS, sex and prior PCI. Pts were treated up to 2 years or until progression or unacceptable toxicity. Primary endpoint was overall survival (OS) for nivo+ipi vs pbo. Secondary endpoints included OS for nivo vs pbo and progression-free survival (PFS) per blinded independent central review for nivo+ipi vs pbo and nivo vs pbo.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      Minimum study follow-up was 9 months. Baseline characteristics were balanced between arms. OS was not significantly prolonged with nivo+ipi vs pbo (HR, 0.92; 95% CI 0.75–1.12; P = 0.3693). OS was also not prolonged for nivo vs pbo (HR, 0.84; 95% CI 0.69–1.02), although not formally tested due to statistical hierarchy. PFS HRs vs pbo were: nivo+ipi, 0.72 (0.60–0.87); nivo, 0.67 (0.56–0.81). Rates of all-grade (grade 3–4) tx-related adverse events were: nivo+ipi, 86% (52%); nivo, 61% (12%); pbo, 50% (8%). Rates of discontinuation due to tx toxicity were: nivo+ipi, 31%; nivo, 9%; pbo, <1%. Tx-related deaths were: nivo+ipi, 7 (2.5%); nivo, 1 (<1%); pbo, 1 (<1%).

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      In CheckMate 451, maintenance therapy with nivo+ipi (primary endpoint) or nivo did not prolong OS vs pbo for ED-SCLC patients who did not progress on 1L chemo. Safety profiles of nivo+ipi and nivo were consistent with previous reports at this dose/schedule in SCLC.

      b651e8a99c4375feb982b7c2cad376e9 Clinical trial identification

      NCT02538666; Release date: 2 September 2015.

      7a6a3ffa2dadc03a6151ee2c4d6fa383 Editorial acknowledgement

      Writing and editorial assistance was provided by Cristina Tomas, PhD, of Caudex and funded by Bristol-Myers Squibb.

      934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study

      Bristol-Myers Squibb.

      213f68309caaa4ccc14d5f99789640ad Funding

      Bristol-Myers Squibb.

      682889d0a1d3b50267a69346a750433d Disclosure

      T.K. Owonikoko: Research support: AbbVie, Adaptimmune, Amgen, AstraZeneca, Bristol-Myers Squibb, Corvus, G1 Therapeutics, Novartis, Pfizer, Regeneron/Sanofi; Advisory board: AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Lilly/Armo, PharmaMar, Xcovery; IRC/DSMB: EMD Serono, Roche/Genentech; Co-founder: Cambium Oncology. H.R. Kim: Speakers bureau, honoraria: AstraZeneca, ONO/Bristol-Myers Squibb; Consultant: Roche. R. Govindan: Consultant/advisory committees: AbbVie, Adaptimmune, AstraZeneca, Celgene, Ignyta, Inivata, Merck, Nektar, Pfizer, Roche. N. Ready: Advisor: AbbVie, G1 therapeutics, Merck, Novartis; Advisor/speaker: Bristol-Myers Squibb, Celgene; Education: AstraZeneca, EMD Serrano, Tesaro. M. Reck: Honoraria for lectures and consultancy: AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Lilly, Merck, MSD, Novartis, Pfizer, Roche. S. Peters: Honoraria, education grants, consultancy, attended advisory boards, and/or provided lectures: AbbVie, Amgen, AstraZeneca, Bayer, Biocartis, Boehringer Ingelheim, Bristol-Myers Squibb, Clovis, Daiichi Sankyo, Debiopharm, Eli Lilly, F. Hoffmann-La Roche, Foundation Medicine, Illumina, Janssen, Merck Sharp and Dohme, Merck Serono, Merrimack, Novartis, PharmaMar, Pfizer, Regeneron, Sanofi, Seattle Genetics, Takeda. A. Navarro: Advisory role: Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, Roche; Safety committee member: Oryzon Genomics; Travel support: Boehringer Ingelheim, Pfizer. J. Rodriguez-Cid: Investigational resources: AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, MSD, Novartis, Roche, Takeda; Advisory role: AbbVie, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Eisai, MSD, Novartis, Pfizer, Roche, Takeda; Speaker role: AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, Takeda. M. Schenker: For clinical trial participation (as PI/SI) my institution and I have received funds from: AbbVie, Amgen, Astellas, AstraZeneca, Bayer, Bioven, Bristol-Myers Squibb, Eisai, Eli Lilly, Gilead, Merck Serono, MSD, Mylan, Nano Carrier, Novartis, Pfizer, PharmaMar, Regeneron, Roche, Samsung D. Morgensztern: Advisory board: AbbVie, Bristol-Myers Squibb, PharmaMar, Takeda. J. Fairchild: Stock ownership: Bristol-Myers Squibb. C. Baudelet: Employee: Bristol-Myers Squibb. K. Park: Advisor: Bristol-Myers Squibb. All other authors have declared no conflicts of interest.

      cffcb1a185b2d7d5c44e9dc785b6bb25

      Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.

      Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.

    • +

      LBA3 - Efficacy and safety of first-line durvalumab (D) ± tremelimumab (T) vs platinum-based chemotherapy (CT) based on clinical characteristics in patients with metastatic (m) NSCLC: Results from MYSTIC (ID 376)

      14:45 - 16:15  |  Author(s): Solange Peters

      • Abstract
      • Presentation
      • Slides

      Background

      In MYSTIC (NCT02453282), an open-label, Phase 3 trial of first-line D (anti-PD-L1) ± T (anti-CTLA-4) vs CT in mNSCLC, while not statistically significant, a clinically meaningful improvement in overall survival (OS) was seen with D vs CT in pts with tumour cell PD-L1 expression ≥25% (TC ≥25% [primary analysis population]; D vs CT, HR 0.76 [97.54% CI 0.56–1.02], p=0.036; D+T vs CT, HR 0.85 [98.77% CI 0.61–1.17], p=0.202). Here we report OS in clinically relevant pt subgroups and safety results from MYSTIC.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      Immunotherapy/CT-naïve pts with mNSCLC were randomised (1:1:1) to D (20 mg/kg q4w); D (20 mg/kg q4w) + T (1 mg/kg q4w for 4 cycles); or CT. OS was analysed in pt subgroups based on baseline clinical characteristics in the PD-L1 TC ≥25% population (prespecified: age, gender, race, histology, smoking history and immune cell [IC] PD-L1 expression ≥25% vs <25%; post hoc: ECOG performance status). Safety (CTCAE v4.03) and tolerability were evaluated in all treated pts.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      The subgroup analysis included 488 pts (D, 163; D+T, 163; CT, 162). Baseline characteristics were balanced between treatment groups. Treatment with D±T resulted in numerical improvement in OS vs CT in most clinical subgroups. OS in pts aged ≥65 y, PD-L1 IC ≥25%, and performance status 0 showed a HR (95% CI) of 0.66 (0.45, 0.95), 0.63 (0.38, 1.04), and 0.54 (0.34, 0.84), respectively, with D vs CT and a HR (95% CI) of 0.72 (0.50, 1.02), 0.64 (0.39, 1.05), and 0.76 (0.50, 1.14) with D+T vs CT. Rates of TRAEs leading to discontinuation and imAEs were highest with D+T and rates of Grade ≥3 TRAEs were highest with CT (Table).

      D (n=369)D+T (n=371)CT (n=352)
      Any TRAE leading to discontinuation (PT), n (%)20 (5.4)49 (13.2)33 (9.4)
      →Pneumonitis3 (0.8)7 (1.9)1 (0.3)
      →Interstitial lung disease2 (0.5)5 (1.3)1 (0.3)
      →Blood creatinine increased01 (0.3)4 (1.1)
      →Colitis05 (1.3)0
      →Diarrhoea04 (1.1)1 (0.3)
      Any Grade ≥3 TRAE (PT), n (%)55 (14.9)85 (22.9)119 (33.8)
      →Anaemia0036 (10.2)
      →Neutropenia1 (0.3)035 (9.9)
      →Fatigue6 (1.6)8 (2.2)7 (2.0)
      →Thrombocytopenia0018 (5.1)
      →Lipase increased3 (0.8)13 (3.5)1 (0.3)
      Any imAE (grouped term), n (%)50 (13.6)105 (28.3)12 (3.4)
      →Hypothyroidism21 (5.7)28 (7.5)2 (0.6)
      →Pneumonitis8 (2.2)25 (6.7)5 (1.4)
      →Diarrhoea7 (1.9)17 (4.6)1 (0.3)
      →Rash5 (1.4)16 (4.3)2 (0.6)
      →Colitis2 (0.5)12 (3.2)0

      5 most common events in each category listed in descending order of frequency across the 3 treatment arms. PT, preferred term; TRAE, treatment-related AE; imAE, immune-mediated AE.

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      In MYSTIC, results of OS analyses across most pt subgroups showed favourable HRs for D±T vs CT, consistent with the overall primary analysis. The safety profile of D±T was manageable and consistent with previous studies with lower rates of Grade ≥3 TRAEs reported compared to CT.

      b651e8a99c4375feb982b7c2cad376e9 Editorial acknowledgement

      Medical writing support, which was in accordance with Good Publication Practice (GPP3) guidelines, was provided by Samantha Holmes, PhD, of Cirrus Communications (Macclesfield, UK), an Ashfield company, and was funded by AstraZeneca.

      934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study

      AstraZeneca PLC.

      213f68309caaa4ccc14d5f99789640ad Funding

      AstraZeneca.

      682889d0a1d3b50267a69346a750433d Disclosure

      B.C. Cho: Grants/research support: Novartis, AstraZeneca, Yuhan, ONO/BMS, MSD, Bayer; Advisor/honoraria fees: AstraZeneca, Roche, Boehringer Ingelheim, Yuhan, BMS, MSD, Novartis; Speaker’s bureau fees: AZ, BMS, MSD, Novartis. N. Reinmuth: Personal fees: BMS, Roche, AstraZeneca, Takeda, Novartis, Boehringer Ingelheim, MSD, Lilly, outside the conduct of the study. A. Smolin: Grants: AstraZeneca; Grants, personal fees: AstraZeneca, Roche, MSD, BMS; Personal fees: BIOCAD, Boehringer Ingelheim. S.J. Antonia: Advisory boards/contracted research: Novartis; Advisory boards: BMS, Merck, CBMG, Boehringer Ingelheim, AstraZeneca, Memgen, FLX Bio, Nektar, Venn. G. Robinet: Grants, personal fees: AstraZeneca, MSD; Personal fees: Boehringer Ingelheim. R. Natale: Spouse employed (Medical Science Liaison): AstraZeneca - However, her salary and compensation is completely unrelated to the contracted research work performed at my institution for which I am a co-investigator. E.B. Garon: Research funding: Merck, Genentech, AstraZeneca, Novartis, Lilly, BMS, Mirati Therapeutics, Dynavax, Iovance Biotherapeutics.  K. Nakagawa: Research funding: GlaxoSmithKline K.K., AstraZeneca K.K., Kyowa Hakko Kirin, Pfizer Japan Inc., AbbVie Inc., Novartis Pharma K.K., Nippon Boehringer Ingelheim, Daiichi Sankyo, Eli Lilly Japan K.K., MSD K.K., Quintiles Inc., Ono Pharmaceutical, BMS, EPS International, Chugai Pharmaceutical, ICON Japan K.K., Gritstone Oncology, Inc., Linical, Yakult Honsha, PAREXEL International Corp., Otsuka Pharmaceutical, Astellas Pharma Inc., AC Medical Inc., Taiho Pharmaceutical, Merck Serono, EPS Associates, Quintiles Inc., Japan Clinical Research Operations, Eisai, PPD-SNBL K.K., Takeda Pharmaceutical, Covance Inc., inVentiv Health Japan, A2 Healthcare Corp., EP-CRSU; Honoraria: Astellas Pharma Inc., AstraZeneca K.K., Novartis Pharma K.K., Pfizer Japan Inc., Chugai Pharmaceutical, Ono Pharmaceutical, Nippon Boehringer Ingelheim, BMS, Kissei Pharmaceutical, Eli Lilly Japan K.K., MSD K.K., EPS Holdings Inc., Showa Yakuhin Kako, Clinical Trial, CareNet, Inc., Nikkei Business Publications, Inc., Nichi-Iko Pharmaceutical, Daiichi Sankyo, Taiho Pharmaceutical, AYUMI Pharmaceutical Corporation, Kyowa Hakko Kirin, Sym Bio Pharmaceuticals, Medicus Shuppan Publishers, Reno Medical K.K., Yodosha, Nanzando; Consulting or advisory role: Astellas Pharma Inc., Eli Lilly Japan K.K., Ono Pharmaceutical, Takeda Pharmaceutical. S. Peters: Personal fees: AbbVie, Amgen, AZ, Bayer, Biocartis, BI, BMS, Clovis, Daiichi Sankyo, Debiopharm, Eli Lilly, F. Hoffmann-La Roche, Foundation Medicine, Illumina, Janssen, MSD, Merck Serono, Merrimack, Novartis, Pharma Mar, Pfizer, Regeneron, Sanofi, Seattle Genetics, Takeda; Non-financial support: Amgen, AZ, BI, BMS, Clovis, F. Hoffmann-La Roche, Illumina, MSD, Merck Serono, Novartis, Pfizer. F. Liu, P. Thiyagarajah: Full-time employment: AstraZeneca. N.A. Rizvi: Advisory boards: AbbVie, AZ, BMS, EMD Serono, Genentech, GSK, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Neogenomics, Oncomed, Gritstone, Bellicum; Equity: Oncomed, Gritstone, Bellicum, ARMO; Royalties: PGDX (patent filed by MSKCC).  All other authors have declared no conflicts of interest.

      cffcb1a185b2d7d5c44e9dc785b6bb25

      Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.

      Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.

  • +

    Immunotherapy in stage IV (ID 13)

    • Event: ELCC 2019
    • Type: Educational session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/11/2019, 09:00 - 10:30, Room B
    • +

      Combo I-O/I-O (ID 35)

      09:00 - 10:30  |  Presenting Author(s): Solange Peters

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

      Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.

      Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.

  • +

    Lunch & Poster Display session (ID 58)

    • Event: ELCC 2019
    • Type: Poster Display session
    • Track:
    • Presentations: 3
    • Moderators:
    • Coordinates: 4/11/2019, 12:30 - 13:00, Hall 1
    • +

      101TiP - PACIFIC-R: First real-world study of patients with unresectable, stage III NSCLC treated with durvalumab after chemoradiotherapy (ID 236)

      12:30 - 13:00  |  Author(s): Solange Peters

      • Abstract

      Background

      Approximately 30% of patients (pts) with non-small-cell lung cancer (NSCLC) are diagnosed with Stage III disease, which is often unresectable. Historically, the standard of care (SoC) has been platinum-based chemoradiotherapy (CRT), but outcomes have been poor. Durvalumab is a selective high-affinity, human IgG1 monoclonal antibody that blocks PD-L1 binding to PD-1 and CD80. In the phase 3 PACIFIC trial of durvalumab versus placebo in pts with unresectable, Stage III NSCLC without progression after concurrent CRT (cCRT), both primary endpoints progression-free survival (PFS) and overall survival (OS) were met and significantly improved with durvalumab (HR for PFS, 0.52; 95% CI 0.42–0.65; P < 0.001; HR for OS, 0.68; 99.73% CI 0.47–0.997; P = 0.0025) with similar safety between treatments (Antonia et al, NEJM 2017; 2018). Based on these findings, the PACIFIC regimen (durvalumab following CRT) is becoming the SoC. PACIFIC-Real World (PACIFIC-R) will assess if durvalumab treatment after cCRT shows similar efficacy and safety in a large, real-world population.

      a9ded1e5ce5d75814730bb4caaf49419 Trial design

      PACIFIC-R is an international, observational study that will enroll ∼1200 NSCLC pts who have received durvalumab as part of early access programs (EAPs) between Sept 2017 and Dec 2018. In the EAP, eligible pts are adults with histologically or cytologically documented unresectable, Stage III NSCLC, regardless of tumor PD-L1 expression, who have not progressed after definitive CRT. Pts received durvalumab (10 mg/kg intravenously) every two weeks. Pts will be enrolled in the PACIFIC-R study after discontinuation of the EAP in participating countries. Data will be abstracted from pts’ medical records at several time points within the 5 year study period. Primary endpoints are PFS (investigator assessed) and OS. Secondary endpoints include PFS and OS in pt subgroups; time to distant metastases; sites of disease progression; adverse events of special interest leading to treatment interruption, discontinuation or medical intervention; and descriptive analyses of demographic and clinical characteristics of pts treated with durvalumab in a real-world setting. Recruitment for this study is ongoing.

      d9b324a48b043b3d87bc9b3fe620f260 Clinical trial identification

      NCT03798535.

      7a6a3ffa2dadc03a6151ee2c4d6fa383 Editorial acknowledgement

      Medical writing support, which was in accordance with Good Publication Practice (GPP3) guidelines, was provided by James King of Cirrus Communications (Macclesfield, UK), an Ashfield company, and was funded by AstraZeneca.

      934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study

      AstraZeneca AB.

      213f68309caaa4ccc14d5f99789640ad Funding

      AstraZeneca AB.

      682889d0a1d3b50267a69346a750433d Disclosure

      N. Girard: Personal fees: AstraZeneca, MSD, BMS, Roche, during the conduct of the study. F. Mornex, D.C. Christoph, R. Fietkau, J. Field, P. Garrido Lopez: Conflict of Interests not immediately avaliable, will be following up with congress directly to provide as soon as possible. A.R. Filippi: Personal fees: AstraZeneca during the conduct of the study. McDonald: Personal fees: AstraZeneca, Elekta; Research grants: MSD, outside the conduct of the study. S. Peters: Personal fees: AbbVie, Amgen, AZ, Bayer, Biocartis, Boehringer Ingelheim, Bristol-Myers Squibb, Clovis, Daiichi Sankyo, Debiopharm, Eli Lilly, F Hoffman-LaRoche, Foundation Medicine, Illumina, Janssen, Merck, Merrimack, Novartis, PharmaMar, Pfizer, Regeneron, Sanofi. A.B. Klein, M. Licour: Employment, stock: AstraZeneca outside the conduct of the study. M.C. Garassino: Personal fees: MSD, BMS, AstraZeneca, Roche, outside the conduct of the study.

      cffcb1a185b2d7d5c44e9dc785b6bb25

    • +

      56P - CT image standardization is superior to larger but heterogeneous data for robust radiomic models (ID 433)

      12:30 - 13:00  |  Author(s): Solange Peters

      • Abstract

      Background

      Radiomics is a promising tool for identification of new prognostic biomarkers. Radiomic models are often based on single-institution data however multi-centric data, highly heterogeneous due to different scanning protocols, reflect better the clinical reality. Robustness studies are crucial to find features robust to e.g. scanner settings. We study if a CT radiomics overall survival (OS) model trained on multi-centric data with robust feature pre-selection can achieve a similar performance as a model on standardized data.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      Pre-treatment CT data from 121 IIIA/N2 NSCLC patients from a prospective multi-centric randomized trial (SAKK 16/00, neoadj. chemo- or radiochemotherapy prior to surgery) were used to calculate 1404 radiomic features on the primary tumor. Two OS radiomic models were trained on (1) a sub-cohort with standardized imaging protocol (native CT, standard kernel, n = 84) and on (2) the entire heterogeneous cohort but with robust radiomic feature pre-selection. Robust features were extracted from four robustness studies (contrast, convolution kernel, motion, delineation) using the intra-class correlation coefficient (> 0.9 considered stable). Seperately for each model, principal component (PC) analysis was performed and PCs describing in total 95% data variance were selected. The feature with highest correlation to the PCs were used for the multivariate Cox model with backward selection. Model performances were quantified using Concordance Index (CI), verified with 10-fold cross-validation and compared using bootstrap with resampling.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      Robustness studies revealed 113 stable features. The convolution kernel was the largest influence on the feature stability. Final OS model on the entire heterogeneous data consisted of four and on standardized data of six features (all identified as unstable). The model on standardized data showed significant better prognostic performance compared to the model with robust feature pre-selection based on the entire heterogeneous data (CI = 0.64 and 0.61, p < 0.05, resp.).

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      For our prognostic NSCLC radiomic models image protocol standardization appears superior to using larger but heterogeneous imaging data combined with robust feature pre-selection.

      b651e8a99c4375feb982b7c2cad376e9 Legal entity responsible for the study

      The authors.

      213f68309caaa4ccc14d5f99789640ad Funding

      Swiss National Science Foundation (SNSF) Swiss Group for Clinical Cancer Research SAKK.

      682889d0a1d3b50267a69346a750433d Disclosure

      M. Guckenberger: Board member: European Society for Therapeutic Radiation Oncology (ESTRO). All other authors have declared no conflicts of interest.

      cffcb1a185b2d7d5c44e9dc785b6bb25

    • +

      82TiP - IMpower030: Phase III study evaluating neoadjuvant treatment of resectable stage II-IIIB non-small cell lung cancer (NSCLC) with atezolizumab (atezo) &#x0002B; chemotherapy (ID 183)

      12:30 - 13:00  |  Presenting Author(s): Solange Peters

      • Abstract

      Background

      A standard of care for resectable early-stage NSCLC is surgery alone or in combination with adjuvant or neoadjuvant platinum-based doublet chemotherapy (PT-DC). Still, 30%-70% of patients develop recurrence and die from disease progression, highlighting the need for more effective treatments. Atezo, an anti–programmed death-ligand 1 (PD-L1) antibody that restores anti-tumour immunity, has shown promising efficacy as monotherapy and in combination with chemotherapy in advanced NSCLC. It is hypothesised that the combination of atezo and PT-DC may provide clinical benefit in the neoadjuvant setting by enhancing cancer cell killing and eradicating micrometastases, reducing the risk of disease recurrence. The objective of IMpower030 (NCT03456063) is to evaluate the efficacy and safety of atezo in combination with PT-DC as neoadjuvant treatment for patients with resectable early-stage NSCLC.

      a9ded1e5ce5d75814730bb4caaf49419 Trial design

      IMpower030 is a global, Phase III, double-blind, randomized study in patients with histologically or cytologically confirmed, resectable stage II, IIIA, or select IIIB (T3N2) NSCLC (per AJCC/UICC, 8th ed). Study inclusion requires measurable disease per RECIST v1.1, ECOG PS of 0/1 and eligibility for R0 resection with curative intent and PT-DC. Patients who had received prior therapy for lung cancer or present with nonsquamous NSCLC with activating EGFR mutations or ALK translocation are excluded. Patients will be randomized to receive 4 cycles of neoadjuvant atezo (1200 mg Q3W, Arm A) or placebo (Arm B) in combination with an investigator-selected PT-DC regimen. Following unblinding, patients in Arm A will receive adjuvant atezo treatment for ≤ 16 cycles or until disease recurrence or unacceptable toxicity, and patients in Arm B will receive best supportive care and scheduled observational follow-up. Endpoints will include major pathological response (≤ 10% residual viable tumour tissue at time of resection), investigator-assessed event-free survival and disease-free survival per RECIST v1.1, OS, ORR, pathological complete response and patient-reported outcomes. Exploratory biomarkers will also be evaluated.

      d9b324a48b043b3d87bc9b3fe620f260 Clinical trial identification

      NCT03456063.

      7a6a3ffa2dadc03a6151ee2c4d6fa383 Editorial acknowledgement

      Medical writing assistance for this abstract was provided by Jessica Men, PharmD, 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

      S. Peters: Ad board, honoraria: Daiichi, Debiopharm, FoundMed, Janssen, Merrimack, PharmaMar, Regeneron, Sanofi, Seattle Genetics; Ad boad, honoraria, talk: Lilly, Takeda; Talk, honoraria, investigation in trials: AZ, BI, BMS, Clovis; Ad board, honoraria, talk, investigation in trials: Roche, Merck, Novartis, Pfizer; Ad board, honoraria, investigation in trials: Illumina. A.W. Kim: Full-time employee: University of Southern California; Advisory board: Medtronic, Genentech; Other (support of parent study, funding of editorial support): F. Hoffmann-La Roche. B. Solomon: Support of parent study, funding of editorial support: Roche. D.R. Gandara: Research grants: AstraZeneca, Genentech, Novartis, Merck; Consultant/Advisory board: AstraZeneca, Celgene, CellMax, Genentech, Guardant Health, Inivata, IO Biotech, Lilly, Liquid Genomics, Merck, Samsumg Bioepis; Parent study, medical writing support: Roche. R. Dziadziuszko: Advisor/Board member: Roche, Novartis, Pfizer, Boehringer Ingelheim, AstraZeneca, Bristol-Myers Squibb; Speaker’s Bureau: Roche, Pfizer, Foundation Medicine; Support of parent study, funding of editorial support: Roche. A. Brunelli: Support of parent study, funding of editorial support: F. Hoffmann-La Roche. M.C. Garassino: Grants/research support: MSD, BMS, AZ, Roche, Celgene, Medimmune; Advisory board/Speakers’ bureau: MSD, BMS, AZ, Roche, Celgene, Medimmune, Incyte, Ignyta; Other (support of parent study, funding of editorial support): Roche. M. Reck: Speakers bureau, consulting, advisory role: Roche, Lilly, Pfizer, BI, AZ, MSD, BMS, Merck, Novartis, Celgene; Other (support of parent study, funding of editorial support): Roche. L. Wang, I. To, S.W. Sun, B.J. Gitlitz: Employee: Genentech; Other (support of parent study, funding of editorial support): Roche. A. Sandler: Employee: Genetech; Stock: Roche; Other (support of parent study, funding of editorial support): Roche. N. Rizvi: Consulting: AbbVie, AstraZeneca, BMS, EMD Sorono, Genentech, GSK, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron; Advisory boards: Bellicum, Brooklyn Immunotherapeutics, Neogenomics, Gritstone; Equity: Bellicum, Brooklyn Immunotherapeutics, Gritstone, ARMO Board of Director (2017-2018) with Stock options vested with company acquisition by Lilly (June 25, 2018); Royalties: Personal Genome Diagnostics: Royalties related to patent filed by MSKCC, Determinants of cancer response to immunotherapy (PCT/US2015/062208); Research funding: BMS, Merck; Institutional financial interests: Clinical research: AstraZeneca, BMS, Genentech, GSK, Merck, Regeneron.

      cffcb1a185b2d7d5c44e9dc785b6bb25

  • +

    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
    • +

      Conclusions and key points (ID 637)

      18:00 - 19:00  |  Presenting Author(s): Solange Peters

      • Abstract

      Abstract not provided

    • +

      Introduction (ID 632)

      18:00 - 19:00  |  Presenting Author(s): Solange Peters

      • Abstract

      Abstract not provided

  • +

    Opening and welcome (ID 4)

    • Event: ELCC 2019
    • Type: Opening and welcome
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/10/2019, 13:30 - 13:45, Room B
    • +

      Introduction to ESMO (ID 733)

      13:30 - 13:45  |  Presenting Author(s): Solange Peters

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

      Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.

      Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.

  • +

    Proffered Paper session I (ID 57)

    • Event: ELCC 2019
    • Type: Proffered Paper session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/10/2019, 16:30 - 18:15, Room C
    • +

      LBA4 - Effect of post-study immunotherapy (IO) on overall survival (OS) outcome in patients with metastatic (m) NSCLC treated with first-line durvalumab (D) vs chemotherapy (CT) in the phase III MYSTIC study (ID 379)

      16:30 - 18:15  |  Author(s): Solange Peters

      • Abstract
      • Presentation
      • Slides

      Background

      In MYSTIC (NCT02453282), an open-label, Phase 3 study of first-line D (anti-PD-L1) ± tremelimumab vs platinum-based CT in mNSCLC, while not statistically significant, a clinically meaningful improvement in OS was seen with D vs CT in pts with tumour cell PD-L1 expression ≥25% (PD-L1 TC ≥25%; HR 0.76 [97.54% CI 0.56–1.02], p=0.036). Here we describe subsequent treatment patterns and explore the effect of subsequent IO on the OS outcome with D vs CT.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      IO/CT-naïve mNSCLC pts were randomised to D (20 mg/kg i.v. q4w until disease progression) or CT (up to 6 cycles; pemetrexed maintenance permitted). In-study crossover from CT to D was not allowed. For D vs CT, the primary endpoint was OS in pts with PD-L1 TC ≥25%. Three statistical models were employed in exploratory analyses to evaluate the effect of subsequent (post-study) IO on the OS data: the rank preserving structural failure time (RPSFT) method, the inverse probability of censoring weighting (IPCW) method, and a 2-stage method.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      163 and 162 pts with PD-L1 TC ≥25% were randomised to D and CT, respectively. At data cut-off (04 Oct 2018), 44.8% of pts in the D arm and 58.6% of pts in the CT arm had received subsequent treatment (Table). Most pts started subsequent treatment within 2 mos of discontinuing study treatment. Among pts who received subsequent treatment, IO was administered to 10/73 (13.7%) pts in the D arm and 64/95 (67.4%) pts in the CT arm; most commonly nivolumab. Using the 2-stage method, which was the most appropriate for evaluating the effect of subsequent IO, OS was improved with D vs CT (HR 0.66 [95% CI 0.51, 0.86]).

      Durvalumab (n=163)Chemotherapy (n=162)
      Pts who received study treatment, n (%)161 (98.8)153 (94.4)
      →Pts who discontinued study treatment136 (83.4)152 (93.8)
      →Pts remaining on study treatment25 (15.3)1 (0.6)
      Pts who received any subsequent treatment, n (%)73 (44.8)95 (58.6)
      →Immunotherapy10 (6.1)64 (39.5)
      →→Nivolumab3 (1.8)50 (30.9)
      →→Pembrolizumab4 (2.5)11 (6.8)
      →→Atezolizumab2 (1.2)3 (1.9)
      →→Durvalumab02 (1.2)
      →→Tremelimumab01 (0.6)
      →→Other immunotherapy1 (0.6)2 (1.2)
      →Cytotoxic chemotherapy70 (42.9)58 (35.8)
      →Other systemic therapies*18 (11.0)18 (11.1)

      Denominators for percentages are the number of pts randomised.

      Excluding immunotherapy and cytotoxic chemotherapy.

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      In the MYSTIC study, a markedly higher proportion of pts in the CT arm than in the D arm received subsequent IO, which may have confounded the primary OS outcome. An exploratory analysis showed increased OS benefit with first-line D vs CT after adjusting for the effect of subsequent IO.

      b651e8a99c4375feb982b7c2cad376e9 Editorial acknowledgement

      Medical writing support, which was in accordance with Good Publication Practice (GPP3) guidelines, was provided by Samantha Holmes, PhD, of Cirrus Communications (Macclesfield, UK), an Ashfield company, and was funded by AstraZeneca.

      934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study

      AstraZeneca PLC.

      213f68309caaa4ccc14d5f99789640ad Funding

      AstraZeneca.

      682889d0a1d3b50267a69346a750433d Disclosure

      N. Reinmuth: Personal fees: BMS, Roche, AstraZeneca, Takeda, Novartis, Boehringer Ingelheim, MSD, Lilly, outside the conduct of the study. B.C. Cho: Grants/research support: Novartis, AstraZeneca, Yuhan, ONO/BMS, MSD, Bayer; Advisor/honoraria fees: AstraZeneca, Roche, Boehringer Ingelheim, Yuhan, BMS, MSD, Novartis; Speaker’s bureau fees: AZ, BMS, MSD, Novartis. J. Schneider: Stock/other ownership: AstraZeneca, Bristol-Myers Squibb, Pfizer, Celgene, Loxo; Consulting/advisory role: Takeda Oncology; Research funding: AstraZeneca, Bristol-Myers Squibb. F.A. Shepherd: Consultancy/advisory role: Lilly, AstraZeneca, Boehringer Ingelheim, Merck Serono; Stock ownership: Lilly, AstraZeneca; Honoraria: Lilly, AstraZeneca, BMS, Roche/Genentech, Merck Sharp & Dohme, Merck Serono, Boehringer Ingelheim; Research funding: Lilly, Pfizer, BMS, AstraZeneca, Roche Canada, Merrimack. S. Peters: Personal fees: AbbVie, Amgen, AZ, Bayer, Biocartis, BI, BMS, Clovis, Daiichi Sankyo, Debiopharm, Eli Lilly, F. Hoffmann-La Roche, Foundation Medicine, Illumina, Janssen, MSD, Merck Serono, Merrimack, Novartis, Pharma Mar, Pfizer, Regeneron, Sanofi, Seattle Genetics, Takeda; Non-financial support: Amgen, AZ, BI, BMS, Clovis, F. Hoffmann-La Roche, Illumina, MSD, Merck Serono, Novartis, Pfizer. S.L. Geater: Research grants/funding: AstraZeneca, Roche, Novartis. T. Van Ngoc: Research funding: AstraZeneca, GSK, Novartis. M.C. Garassino: Personal fees: Eli Lilly, Boehringer Ingelheim, Otsuka Pharma, AstraZeneca, Novartis, BMS, Roche, Pfizer, Celgene, Incyte, Inivata, Takeda, Tiziana Science, Clovis, Merck Serono, Bayer, MSD, GSK. F. Liu, D. Clemett, P. Thiyagarajah, M. Ouwens, U. Scheuring: Full-time employment: AstraZeneca. N. Rizvi: Advisory boards: AbbVie, AZ, BMS, EMD Serono, Genentech, GSK, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Neogenomics, Oncomed, Gritstone, Bellicum; Equity: Oncomed, Gritstone, Bellicum, ARMO; Royalties: PGDX (patent filed by MSKCC). All other authors have declared no conflicts of interest.

      cffcb1a185b2d7d5c44e9dc785b6bb25

      Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.

      Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.