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Rosalyn Juergens
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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): Rosalyn Juergens
- Abstract
- Presentation
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).
6f8b794f3246b0c1e1780bb4d4d5dc53Only 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.
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MS28 - IO Combinations in Advanced NSCLC (ID 806)
- Event: WCLC 2018
- Type: Mini Symposium
- Track: Immunooncology
- Presentations: 1
- Moderators:
- Coordinates: 9/26/2018, 13:30 - 15:00, Room 106
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MS28.03 - Combinatorial IO + Chemo (ID 11522)
14:00 - 14:15 | Presenting Author(s): Rosalyn Juergens
- Abstract
- Presentation
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.
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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: 1
- 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): Rosalyn Juergens
- 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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P1.09 - Pathology (Not CME Accredited Session) (ID 941)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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P1.09-04 - Optimization of PD-L1 Testing Specimen Flow in the Greater Hamilton, Ontario Region (ID 12767)
16:45 - 18:00 | Presenting Author(s): Rosalyn Juergens
- Abstract
Background
Immunotherapy targeted at the programmed cell death 1 (PD-1) receptor and its ligand (PD-L1) is a new treatment option for non-small-cell lung cancer (NSCLC). Immunohistochemistry (IHC) for the PD-L1 protein has been shown to predict response. The 22C3 IHC assay is the only clinically validated PD-L1 test. We present the Hamilton, Ontario, Canada experience of local PD-L1 analysis using the 22C3 assay including both histology and cytology specimens.
a9ded1e5ce5d75814730bb4caaf49419 Method
All data for requests for PD-L1 testing from within Hamilton were collected for one year. Unstained slides were cut for IHC analysis. Both histology and formalin fixed cytology specimens were accepted. Slides were sent for PD-L1 staining centrally at Dynacare in Bowmanville, Ontario, Canada. IHC interpretation was done in Hamilton. The assay was positive if ≥50% of tumour cells (TCs) had any intensity staining. The assay was negative if no TCs had staining. The assay was interpreted as low positive if 1-49% TCs had any intensity staining. Samples with less than 100 cells were considered inadequate. Turn around-time was defined as the accession date to PD-L1 sign out date.
4c3880bb027f159e801041b1021e88e8 Result
401 samples were evaluated; 108 cytology(C) and 293 histology(H). 36% of samples tested positive (43%:C;33%:H); 20% of samples tested low positive (14%:C;23%:H); 39% of samples tested negative (29%:C;42%:H); 5% were insufficient for evaluation (15%:C;1%:H). Chi-squared analysis identified a statistically significant (χ2 < 0.02) difference in the distribution of test results comparing histology and cytology. The mean turn-around-time (TAT) was 28.9 days (range 12-144). TAT varied by hospital of origin. TAT for PD-L1 results from the hospital with dedicated thoracic pathologists was on average 10 days shorter than from other Hamilton hospitals. TAT in our hospital with dedicated thoracic pathologists improved with time from a mean of 49 days to a mean of 22 days while TAT from other hospitals did not improve over the course of the year.
8eea62084ca7e541d918e823422bd82e Conclusion
Our cohort mirrors findings in the literature and demonstrates that the 22C3 assay for PD-L1 can be done on both histology and cytopathology specimens; however, the insufficient rates are higher for cytopathology. Cytopathology specimens have a higher PD-L1 positivity rate, a finding that may reflect differences in tumour biology and/or stage in this subgroup. Turnaround times were different based on the hospital of origin, and suggest centralized specimen collection or use of dedicated thoracic pathologists may be advantageous. Correlation with clinical outcomes on our cytology cases will be presented in a separate abstract.
6f8b794f3246b0c1e1780bb4d4d5dc53
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P2.09 - Pathology (Not CME Accredited Session) (ID 958)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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P2.09-08 - Clinical Outcomes of Histology Versus Cytology PD-L1 22C3 Antibody Testing in Advanced Non-Small Cell Lung Cancer (ID 13490)
16:45 - 18:00 | Author(s): Rosalyn Juergens
- Abstract
Background
Immune checkpoint inhibitors (CPIs) are now an accepted standard of care along the treatment algorithm for advanced non-small cell lung cancer (NSCLC). PD-L1 expression using 22C3 immunohistochemistry (IHC) help determine the line of therapy in which CPI are used. Previous studies demonstrated that PD-L1 expression is comparable on cytology versus solid biopsy/histology specimens. We assess the clinical outcomes between patients with PD-L1 expression ≥50% (high positive) tested using cytology versus histology specimens.
a9ded1e5ce5d75814730bb4caaf49419 Method
This retrospective cohort study includes specimens processed between January 2015 to June 2017 on samples dating back to March 2014. Patients were included in the study if they were seen by a medical oncologist for consideration of systemic treatment for advanced NSCLC. Clinical characteristics were extracted from electronic medical records. Overall survival (OS) was defined as time from diagnosis of advanced NSCLC to death and compared by method of PD-L1 analysis (cytology versus histology), adjusting for age, ECOG, weight loss, and receipt of palliative intent radiotherapy, targeted therapy, and CPI.
4c3880bb027f159e801041b1021e88e8 Result
148 (30.8%) of 481 samples tested ≥50% for PD-L1 expression. Amongst those, 32 and 37 patients fulfilled eligibility criteria with cytology and histology samples respectively. Baseline characteristics of the two groups are comparable in age, gender, ECOG, histological subtype, and receipt of CPIs. The cytology group had a significantly higher number of patients with baseline pleural effusion (10 vs 4 patients, p=0.035) and receipt of any systemic therapy (28 vs 22 patients, p=0.009). The histology group received more palliative intent radiation (24 vs 13, p=0.044).
There was no difference in OS between the cytology and histology groups. Median OS in the cytology group was 11.9 versus 8.0 months in the histology group; adjusted HR 0.98 (95% CI 0.43-2.26). Amongst patients who received systemic therapy, survival was longer if patients were exposed to CPI during their course of treatment regardless of cytology or histology groups; adjusted HR 0.45 (95% CI 0.22 – 0.90).
8eea62084ca7e541d918e823422bd82e Conclusion
In advanced NSCLC, CPI treatment guided by specimens analyzed by cytology versus histology were equivalent in survival. Regardless of sample source, patients exposed to CPI in any line of therapy had significantly longer survival than patients without exposure to CPI amongst patients testing high positive for PD-L1. Ongoing analyses are comparing clinical outcomes in patients with other expressions of PD-L1.
6f8b794f3246b0c1e1780bb4d4d5dc53
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P2.13 - Targeted Therapy (Not CME Accredited Session) (ID 962)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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P2.13-13 - Real-World Study of Osimertinib in EGFR T790M-Mutated Non-Small Cell Lung Cancer (NSCLC): ASTRIS Canadian Cohort Analysis (ID 12986)
16:45 - 18:00 | Author(s): Rosalyn Juergens
- Abstract
Background
ASTRIS is an open-label, single-arm, multinational, real world study of osimertinib for patients with advanced/metastatic epidermal growth factor receptor-mutated (EGFRm) T790M-positive non-small cell lung cancer (NSCLC) who previously received therapy with an EGFR tyrosine kinase inhibitor (EGFR-TKI) (NCT02474355). Data cut-off (DCO) for the second interim analysis was 20 October 2017, with 3014 patients enrolled (full analysis set), including 99 patients in Canada.
a9ded1e5ce5d75814730bb4caaf49419 Method
Adult patients with locally advanced/metastatic EGFRm NSCLC, not amenable to curative surgery/radiotherapy, with confirmation of T790M and prior EGFR-TKI therapy were enrolled. Patients were included with World Health Organization performance status of 0 to 2, as well as those with asymptomatic stable central nervous system (CNS) metastases. Patients received osimertinib 80 mg once daily until loss of clinical benefit. The primary efficacy outcome was overall survival (OS), with secondary outcomes of investigator-assessed response rate (RR), progression-free survival (PFS), and time to treatment discontinuation (TTD).
4c3880bb027f159e801041b1021e88e8 Result
From study start (14 January 2016) to DCO (20 October 2017), 99 patients were enrolled at 12 Canadian centres. Median age was 64 years (30-89 years). Patients were 68% female, 57% Asian, and had ECOG 0/1/2 of 22%/65%/13%. Twenty-five patients had CNS metastases at screening. Gefitinib was the most commonly used previous EGFR-TKI (gefitinib, erlotinib and afatinib were 80%, 14%, and 14%, respectively). Thirty-nine percent had previous chemotherapy; 6% previous immunotherapy; 46% previous radiotherapy. All patients had T790M: 75% tissue, 7% blood and 18% cytology. Biomarker testing methods varied, with the majority (61%) identified by Entrogen EGFR kit. At DCO, 45 patients had discontinued treatment. OS data were immature. Median PFS was 11.0 months (95% CI, 8.9-13.3). Median TTD was 14.9 months (95% CI, 11.2-not calculated). RR was 67.0% (95% CI, 56.7-76.2); sub-analyses showed RR of 69.9% (58.0-80.1), 66.7% (22.3, 95.7) and 55.6% (30.8, 78.5) for patients with T790M by tissue, blood and cytology, respectively. Serious adverse events (AEs) were reported for 18% of patients. AEs leading to dose modifications and discontinuations were reported for 12% and 5% of patients, respectively.
8eea62084ca7e541d918e823422bd82e Conclusion
The Canadian results from this real world study of osimertinib in advanced/metastatic EGFRm T790M-positive NSCLC, which includes heavily pretreated patients and various approaches to biomarker testing, were comparable to outcomes reported in the phase III study AURA3 (NCT02151981). These findings provide further support for osimertinib as standard of care for EGFRm T790M-positive NSCLC.
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