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Scott A. Laurie



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    MA02 - Improving Outcomes for Patients with Lung Cancer (ID 895)

    • Event: WCLC 2018
    • Type: Mini Oral Abstract Session
    • Track: Advanced NSCLC
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 10:30 - 12:00, Room 201 BD
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      MA02.11 - Achieving Value in Cancer Diagnostics: Blood Versus Tissue Molecular Profiling - A Prospective Canadian Study (VALUE) (ID 13611)

      11:40 - 11:45  |  Author(s): Scott A. Laurie

      • Abstract
      • Presentation
      • Slides

      Background

      Cell-free DNA (cfDNA) next-generation sequencing (NGS) has emerged as an effective molecular profiling technique that is potentially faster and cost-saving in comparison to standard-of-care (SOC) tumour biopsy and tissue-based profiling. In a public payer system, the added value of cfDNA blood-based profiling compared to SOC remains unknown. This study will determine the incremental clinical utility and cost of cfDNA NGS versus SOC genotyping in patients with advanced non-squamous non-small cell lung cancer (NSCLC).

      a9ded1e5ce5d75814730bb4caaf49419 Method

      This multicentre, non-randomized, longitudinal study will be conducted at 6 sites across Canada (BC, Alberta, Ontario, Quebec). The Guardant360® assay will be used to perform plasma-based cfDNA testing, and includes mutations, rearrangements and copy number variations in 73 known cancer associated genes. Two patient cohorts will be recruited: (1) treatment naïve patients with ≤10 pack year smoking history; and (2) patients with known abnormalities of EGFR, ALK, ROS-1 or BRAF after disease progression on all standard targeted therapies. SOC tissue profiling will be performed for all patients per institutional standards. The study will begin recruiting in May 2018, with estimated completion in 12 months. The primary endpoints are comparison of response rate (RR), progression-free survival (PFS) and time-to-treatment failure (TTF) using cfDNA versus tissue genomic testing. Secondary endpoints include time to treatment initiation, number of actionable genomic abnormalities identified, result turnaround time, potentially avoidable repeat tissue biopsies, costs, patient-reported quality of life (EQ-5D) and willingness-to-pay. Exploratory analyses of treatment outcomes in selected molecular subgroups will also be undertaken, including response to immunotherapy in those with KRAS/STK11 co-mutations. A decision-analytic model will be developed to perform cost-consequence analyses using a cfDNA versus tissue-based approach.

      4c3880bb027f159e801041b1021e88e8 Result

      A total of 210 patients will be recruited across Canada, (Cohort 1 N=150, Cohort 2 N=60). Based on testing with either blood-based GUARDANT360TM or tissue-based profiling, the costs and benefits of blood-based profiling either at initial diagnosis or upon TKI progression will be determined versus initial or repeat tumour biopsy and tissue-based profiling. Data from patients accrued until 08/2018 will be presented at the meeting.

      8eea62084ca7e541d918e823422bd82e Conclusion

      This study will determine the added value of cfDNA blood-based genotyping compared to SOC from the perspective of a public payer system (Canada).

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    P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 2
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.01-02 - Long-Term Outcomes with First-Line Nivolumab Plus Ipilimumab in Advanced NSCLC: 3-Year Follow-Up from CheckMate 012 (ID 12380)

      16:45 - 18:00  |  Author(s): Scott A. Laurie

      • Abstract

      Background

      CheckMate 012 (NCT01454102) is a phase 1 study evaluating several nivolumab monotherapy/combination regimens as first-line treatment for advanced non-small cell lung cancer (NSCLC). CheckMate 012 was the first study to suggest the benefit of nivolumab plus ipilimumab in NSCLC. In the phase 3 study CheckMate 227, nivolumab plus ipilimumab recently demonstrated significantly improved progression-free survival (PFS) as well as more frequent, deeper, and more durable responses versus chemotherapy in patients with chemotherapy-naive advanced NSCLC and high tumor mutational burden (TMB). Here, we provide 2-year follow-up results for nivolumab plus ipilimumab from CheckMate 012. Three-year results, the longest follow-up to date for an immuno-oncology combination in NSCLC, will be presented.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Eligible patients had recurrent stage IIIb or stage IV chemotherapy-naive NSCLC and Eastern Cooperative Oncology Group performance status 0–1. Patients received nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 12 weeks (n=38) or every 6 weeks (n=39) until disease progression, unacceptable toxicity, or consent withdrawal; pooled results of these two cohorts are presented. Endpoints included safety/tolerability (primary); objective response rate and PFS (secondary); and overall survival (OS), chemotherapy-free survival (CFS), and efficacy by TMB status (exploratory).

      4c3880bb027f159e801041b1021e88e8 Result

      With 2 years of follow-up, no new safety signals were observed. Thirty-three of 77 patients (43%) achieved objective responses, including six investigator-assessed complete responses (8%), three of which were complete pathological responses. Responses were durable (median duration of response, not reached; range, 1.4+ to 27.9+ months). The 2-year PFS rate was 29%. At the time of database lock, 32 of 34 patients (94%) with OS ≥2 years were alive, with four (12%) remaining on treatment and progression-free; 14 (41%) were off treatment and progression-free without subsequent therapy. Three-year follow-up results to be presented include OS, PFS, and select data on CFS, efficacy by TMB status, and characteristics of long-term survivors.

      8eea62084ca7e541d918e823422bd82e Conclusion

      With long-term follow-up, nivolumab plus ipilimumab continued to demonstrate durable clinical benefit and a consistent safety profile as first-line treatment for patients with advanced NSCLC.

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      P1.01-52 - BR-34- Randomized Trial of Durvalumab & Tremelimumab +/- Platinum Chemotherapy in Patients with Metastatic Squamous or Non-Squamous NSCLC (ID 11791)

      16:45 - 18:00  |  Author(s): Scott A. Laurie

      • Abstract
      • Slides

      Background

      Background- Immunotherapy improves survival of patients with non-small cell lung cancer (NSCLC). Current clinical trials are studying various combinations of PD-1/PD-L1 inhibitors and CTLA-4 agents with or without chemotherapy, to enhance treatment efficacy. This trial will determine the effects of adding platinum chemotherapy to combination of check point blockade with durvalumab and tremelimumab in the first line treatment of advanced non-small cell lung cancer.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Method- BR-34 is a CCTG led randomized proof-of-concept trial of durvalumab and tremelimumab, with or without platinum-based chemotherapy in patients with metastatic squamous or non-squamous NSCLC. Patients who have histologically confirmed Stage IV NSCLC and wild type EGFR and ALK, PDL-1 unselected, with measurable disease by RECIST 1.1, and available tissue for biomarker testing are eligible and are stratified by stage, histology and smoking status. Primary end point is overall survival. Secondary end points include progression free survival at 1 year, overall response rate, quality of life, cost effectiveness and correlative studies on tissue and blood (including PD-L1, tumour mutation burden and cell-free DNA) with outcomes and response, and PFS by iRECIST (exploratory). In total 300 patients will be recruited from Canada, Australia and Italy. Arm A will receive 4 cycles of fixed doses of tremelimumab (T) 75 mg plus durvalumab (D) 1500 mg every 28 days IV, followed by durvalumab (D) maintenance and Arm B will receive standard platinum-doublet chemotherapy in combination with T+D every 21 days for 4 cycles, followed by maintenance D (with pemetrexed for those with non-squamous histology), until progression.

      4c3880bb027f159e801041b1021e88e8 Result

      Results- BR-34 was initiated in February 2017 in Canada and total 150 patients have been randomized as of April 2018, including 137 from Canada and 13 from Australia. 28 sites are open to accrual in Canada, 15 in Australia the trial will soon be opened in Italy.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Conclusion- At the current rate of accrual, the CCTG BR-34 trial should be fully accrued by Q1 2019. This is the first randomized trial of combination checkpoint blockade +/- platinum-doublet chemotherapy in advanced non-small cell lung cancer.

      Acknowledgements: BR-34 is an academic, co-operative group trial led by Canadian Cancer Trials Group (CCTG) in collaboration with ALTG and NHMRC Clinical Trials Centre, with support from AstraZeneca and Canadian cancer society. NCT03057106

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    PC09 - Approaches to Management of Advanced NSCLC (ID 848)

    • Event: WCLC 2018
    • Type: Pro-Con Session
    • Track: Advanced NSCLC
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/26/2018, 10:30 - 12:00, Room 107
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      PC09.05 - Debate 2: Large Cell Neuroendocrine Carcinoma Should Be Treated like NSCLC or SCLC? - SCLC (ID 11642)

      11:30 - 11:45  |  Presenting Author(s): Scott A. Laurie

      • 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.