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Gilberto Castro
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MA19 - Looking at PROs in Greater Detail - What Patients Actually Want and Expect (ID 147)
- Event: WCLC 2019
- Type: Mini Oral Session
- Track: Treatment in the Real World - Support, Survivorship, Systems Research
- Presentations: 1
- Now Available
- Moderators:Joaquim Bosch-Barrera, Virginia Calvo De Juan
- Coordinates: 9/10/2019, 11:30 - 13:00, Interlaken (1988)
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MA19.04 - Discussant - MA19.01, MA19.02, MA19.03 (Now Available) (ID 3796)
11:30 - 13:00 | Presenting Author(s): Gilberto Castro
- Abstract
- Presentation
Abstract not provided
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P1.09 - Pathology (ID 173)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Pathology
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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P1.09-02 - Comprehensive Genomic Profiling of Non-Small Cell Lung Cancer in Brazil (GBOT 0118/LACOG 0418) (Now Available) (ID 2048)
09:45 - 18:00 | Author(s): Gilberto Castro
- Abstract
Background
Lung cancer is the leading cause of cancer-related morbidity and mortality worldwide. Cancer driver mutations have been examined extensively and are the basis for modern precision therapy. The access of genomic tests in Brazil and, therefore, the prevalence of driver mutations of NSCLC in the country is not well described. The objective of this study is to carry out an epidemiological analysis of the somatic genetic profile of Brazilian NSCLC samples tested with FoundationOne®.
Method
GBOT 0118/LACOG 0418 is a retrospective cross-sectional study with patients diagnosed with NSCLC in Brazil and who performed comprehensive genomic profiling (CGP) using FoundationOne® or FoundationACT®. Raw data containing anonymous clinical-pathological characteristics and the results of CGP was analyzed. We described the molecular profile of patients using descriptive statistics. Categorical variables are presented as frequency and compared using the Chi-square test.
Result
We obtained a total of 513 CGP results, 457 (89.0%) from Foundation One® and 56 (10.9%) from FoundationACT®. Adenocarcinoma was the most common histological subtype (83.8%) followed by NSCLC NOS (16.1%). Median age at testing date was 64 years, and 51.27% were male. EGFR activating mutations were detected in 23.39% patients, ALK rearrangements in 5.65%, ROS1 rearrangements in 2.34%, RET alterations in 2.53%, BRAF mutations in 5.46%, KRAS mutations in 25,15% and NTRK fusions in 0,58% . Tumor mutational burden (TMB) analysis was available for 80.51% of samples tested and was measured in mutation per megabase. TMB were divided into three groups based on the Foundation Medicine reports: low (1-5 mutations/mb), intermediate (6-19 mutations/mb) and high (≥ 20 mutations/mb). The of tumors had low (42.69%) or intermediate (32.36%) TMB, and only 5.46% had high TMB.
Table 1. Frequency of somatic genetic alterations in tumors tested with FoundationOne® and availability of targeted therapies in Brazil.
GENE
Frequency in NSCLC (%)
Availability in Brazil
EGFR
23.39
Approved
ALK
5.65
Approved
ROS1
2.43
Approved
BRAF
5.46
Approved
KRAS
25.15
No drugs available
RET
2,53
Drugs available but not approved
NTRK
0,58
Drugs available but not approved
Conclusion
This is the most comprehensive study describing CGP of NSCLC in Brazil using FoundationOne® or ACT. Our study shows rates of EGFR mutations and ALK rearrangements similar to those previously described. The knowledge of the molecular patterns of NSCLC in Brazil may help to improve health policies and access to targeted agents in the country.
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P2.01 - Advanced NSCLC (ID 159)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.01-17 - CANOPY-1: Phase 3 Study of Canakinumab/Placebo+Pembrolizumab+Platinum-Chemotherapy in Untreated Stage IIIB-IV NSCLC Pts (ID 1209)
10:15 - 18:15 | Author(s): Gilberto Castro
- Abstract
Background
Interleukin-1β (IL-1β) inhibition with canakinumab reduced the incidence of and mortality due to lung cancer among patients with atherosclerosis in CANTOS trial. Inhibition of IL-1β driven inflammation may lead to a tumor microenvironment more susceptible to anti-PD-(L)1 therapies. Recent studies have shown that low levels of 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 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.
Result
Section not applicable
Conclusion
Section not applicable
