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Enriqueta Felip



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    OA01 - Precision Medicine and Personalized Therapy for Lung Cancer (ID 1)

    • Event: NACLC 2019
    • Type: Oral Abstract Session
    • Track:
    • Presentations: 1
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      OA01.10 - Comparing Regional Results from the IASLC Global Survey on Molecular Testing in Lung Cancer (ID 37)

      14:00 - 15:40  |  Author(s): Enriqueta Felip

      • Abstract
      • Slides

      Background:
      The IASLC conducted an international survey to evaluate current practice and barriers to molecular testing (MT). We compared results from US/Canada to other regions of the world.


      Method:
      The survey contains a 7-question introduction, followed by 1 of 3 specific tracks: 32 questions for those requesting tests/treating patients, 45 questions on performing/interpreting assays, and 24 questions on tissue acquisition. Respondents also provided barriers to implementing/offering MT in free-response fields. Surveys were available in 7 languages and translated into English for analysis. IASLC criteria were used to group responses into the following geographic regions: US/Canada, Asia, Europe, Latin America, and the rest of the world (Other). P-values reported are for comparisons across regions using the Chi-squared test, free-text was analyzed with Nvivo.


      Results:
      There were 2,537 responses from 102 countries. 11% of responses were from US/Canada, 52% Asia, 19% Europe, 11% Latin America, and 7% Other. Respondents varied by track: 66% requesting/treating, 12% performing/interpreting assays, 13% tissue specimen acquisition, and 8% not involved with MT. MT rates are low across the board but vary significantly by region (p<0.0001). 51% of respondents in the US/Canada who test/treat patients and 61% globally report that most patients in their country do not receive MT. The most frequent barrier to MT in US/Canada was cost (same for all regions), second-most is turn-around time, which differs between regions. Other frequently reported barriers were quality/standards, access, and awareness. 52% of respondents who perform/interpret assays are unsure/not satisfied with the state of MT in their country, with 45% reporting this in the USA/Canada (p=0.0066). 29% of respondents who test/treat patients report that it took >10 days to receive results, occurring most frequently in USA/Canada (60%) (p<0.0001). Globally, 37% have trouble understanding MT result reports, most of whom cited a need for more technical and scientific knowledge (22% in USA/Canada, p<0.0001). 23% of respondents who perform/interpret assays reported >10% of cases are rejected due to inadequate samples (19% in USA/Canada, p=0.5590); However, 47% stated there is no policy or strategy to improve the quality of the tissue samples in their country. Finally, 33% of all respondents (26% USA/Canada, p=0.0041) were not aware of CAP/IASLC/AMP guidelines for MT.


      Conclusion:
      MT usage varies globally, and common barriers include cost, time, quality, and awareness. Many respondents were not satisfied with the state of MT in lung cancer and many were unaware of existing guidelines. Global and regional strategies should be developed to address these barriers.

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    PD01 - Poster Discussion Session (ID 4)

    • Event: NACLC 2019
    • Type: Poster Discussion Session
    • Track:
    • Presentations: 1
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      PD01.05 - CANOPY-1: Phase 3 Study of Canakinumab/Placebo+Pembrolizumab+Platinum-chemotherapy in Untreated Stage IIIB-IV NSCLC Patients (ID 70)

      15:45 - 16:45  |  Author(s): Enriqueta Felip

      • Abstract

      Background:
      Interleukin-1? (IL-1?) inhibition with canakinumab reduced the incidence of and mortality due to lung cancer among patients with atherosclerosis in CANTOS trial. Inhibition of IL-1? driven inflammation may lead to a tumor microenvironment more susceptible to anti-PD-(L)1 therapies. Recent studies have shown that low levels of C-reactive protein (CRP) at baseline or decreased levels over time correlated with improved responses to anti-PD-(L)1 agents, providing rationale for combination of canakinumab and Pembrolizumab (PEM).


      Method:
      CANOPY-1 (NCT03631199) is a double-blind, randomized, placebo (Pb)-controlled, phase III trial to determine efficacy and safety of PEM + platinum-based chemotherapy (Ctx) ± canakinumab in untreated stage IIIB/IIIC-IV squamous and non-squamous NSCLC patients (pts). It is a 2 part study- In Part 1 [open-label safety run-in with 3 cohorts of ~9 pts each to confirm recommended phase 3 canakinumab regimen], pts will receive canakinumab 200 mg s.c (Q3W) + PEM 200 mg i.v (Q3W) + platinum-based Ctx [Cohort A (non-squamous), carboplatin (CBCDA) + pemetrexed (PTX); Cohort B (non-squamous), cisplatin + PTX; Cohort C (squamous or non-squamous), CBCDA + paclitaxel]. In Part 2 [with ~600 pts) to evaluate efficacy and safety of canakinumab combination], pts will be randomized to receive canakinumab/Pb + PEM + platinum-based Ctx (non-squamous, CBCDA or cisplatin + PTX; squamous, CBCDA + paclitaxel or nab-paclitaxel). PEM and platinum-based Ctx will be administered at their approved doses. Randomization (1:1) will be stratified by PD-L1 status, region and histology. In both parts, pts will receive 4 cycles of induction therapy (canakinumab/Pb + PEM + Ctx) followed by maintenance therapy (PEM + canakinumab/Pb +/- PTX) until progressive disease. Primary objectives: confirm recommended phase 3 regimen for canakinumab combination (Part 1), compare PFS and OS between treatment arms (Part 2). Secondary objectives (Part 1 and 2): ORR, DCR, safety, PK and DOR.


      Results:
      Not applicable.


      Conclusion:
      Not applicable.