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Carla Verri
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MA07 - Clinical Questions and Potential Blood Markers for Immunotherapy (ID 125)
- Event: WCLC 2019
- Type: Mini Oral Session
- Track: Immuno-oncology
- Presentations: 1
- Now Available
- Moderators:David R Spigel, Roberto Ferrara
- Coordinates: 9/08/2019, 13:30 - 15:00, Vancouver (2003)
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MA07.03 - A Circulating MicroRNAs-Based Test as Biomarker of Primary and Secondary Resistance in PD-L1 ≥50% NSCLC Treated with Immunotherapy (Now Available) (ID 2495)
13:30 - 15:00 | Author(s): Carla Verri
- Abstract
- Presentation
Background
PD-L1 represents the only clinically approved biomarker to select patients for immunotherapy. However, about 20-25% of PD-L1≥50% NSCLC patients do not benefit of ICIs treatment. We showed that a plasma microRNA signature classifier (MSC), reflecting the switch towards an immunosuppressive profile of immune cells, identifies NSCLC patients with worse prognosis after ICIs, irrespective from PD-L1 expression. Aim of this trial is to prospectively define the MSC role as biomarker of primary or secondary resistance in PD-L1≥50% NSCLC treated with ICIs.
Method
Fifty consecutive advanced NSCLC patients with PD-L1≥50% treated with ICI as first (n=32) or further line were enrolled. Plasma samples, as well as demographics information, smoking history and ECOG PS were collected before starting ICI treatment. The MSC test identified patients at high (H) risk vs intermediate/low (I/L) risk levels. According to RECIST 1.1 criteria, patients were classified as responders (R), patients with stable disease (SD), and progressors (P). Objective Response Rate (ORR), Progression Free Survival (PFS) and Overall Survival (OS) in MSC risk level strata at the baseline were considered as endpoints. For 26 R or SD patients with extended follow-up, additive, not mandatory plasma samples were collected and analyzed at the time of revaluations. To determine changes in the risk level during follow-up, we evaluated changes in the probability of having progressive disease after two consecutive MSC tests, considering all possible combinations.
Result
Overall 17 (34%) R, 17 (34%) patients with SD, 11 (22%) P and 5 (10%) not evaluable patients were identified. Considering the baseline blood samples 11 (22%) NSCLC patients were MSC H. ORR was 0% in MSC H vs 45% for other patients (p=0.0090). Median PFS was 2.3 months for MSC H vs 10.9 months for other patients (HR=0.38; 95%CI=0.17-0.84; p=0.0174). Median OS was 2.9 months for MSC H vs 22.0 months for other patients (HR=0.18; 95%CI=0.07-0.47; p=0.0004). Data remained significant adjusting for age, sex, pack-years and ECOG performance status: PFS HR=0.31 (95%CI=0.13-0.73; p=0.0072) and OS HR=0.13 (95%CI=0.04-0.39; p=0.0003). Among the 26 patients with longitudinal evaluation of MSC risk level, all the 12 patients reaching progression during treatment showed an increase in the risk level (Sign-test p-value=0.0039). Conversely, when considering the 14 NSCLC patients still maintaining SD or responding to ICIs at the time of the analysis, the risk level decreased for 9 (64%) of them (Sign-test p-value=0.1655).
Conclusion
These preliminary results suggest that MSC risk level at the baseline and during treatment could help to identify primary or secondary resistance in PD-L1≥50% NSCLC patients treated with ICIs. Ongoing clinical trials are validating these results.
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PL02 - Presidential Symposium including Top 7 Rated Abstracts (ID 89)
- Event: WCLC 2019
- Type: Plenary Session
- Track:
- Presentations: 1
- Now Available
- Moderators:Giorgio Vittorio Scagliotti, Ramon Rami-Porta
- Coordinates: 9/09/2019, 08:00 - 10:15, Barcelona (2005)
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PL02.04 - Blood MicroRNA and LDCT Reduce Unnecessary LDCT Repeats in Lung Cancer Screening: Results of Prospective BioMILD Trial (Now Available) (ID 907)
08:00 - 10:15 | Author(s): Carla Verri
- Abstract
- Presentation
Background
The National Lung Screening Trial (NLST) showed that lung cancer (LC) screening by three annual rounds of low-dose computed tomography (LDCT) reduced lung cancer mortality, and MILD trial provided additional evidence that extended intervention beyond 5 years, with annual or biennial rounds, enhanced the benefit of screening. The new bioMILD trial tested the additional value of blood microRNA (miRNA) assay at the time of LDCT on a large series of volunteers, with the aim of targeting next LDCT intervals on the basis of individual risk profile.
Method
BioMILD trial offered a lung cancer screening program combining LDCT and blood microRNA assay, to heavy smokers (current or former ≤10 years) aged 50-75 years (clinicaltrials.gov ID: NCT02247453). At baseline, LDCT and miRNA were tested independently with blind evaluation, choosing a 3-year interval for the next repeat in participants with double negative LDCT and miRNA.
Result
From January 2013 to March 2016, bioMILD prospectively enrolled 4,119 volunteers at Istituto Nazionale Tumori of Milan. The median age was 60 years, median pack-years 42, current smokers 79% and females 39%. According to baseline LDCT and miRNA profile, 2384 subjects (58%) with double negative LDCT and miRNA (2neg) were sent to 3-year LDCT repeat, 1526 (37%) with positive miRNA or indeterminate/positive LDCT (1pos) and 209 (5%) with positive miRNA and indeterminate/positive LDCT (2pos) were sent to annual or shorter LDCT repeat, depending on LDCT results. After four screening runs (LDCT 0/1/2/3), a total of 115 LCs were diagnosed (2.8%). Cumulative LC incidence was significantly different in the three groups: 0.6% for 2neg subjects, 3.8% for 1pos and 20.1% for 2pos (p<0.0001); LC mortality was 0.1%, 0.6% and 3.8% respectively (p<0.0001). Interval cancer incidence, proportion of stage I and resected LC were not statistically different among groups.
Conclusion
The combination of microRNA assay and LDCT is a valuable and safe tool to assess individual risk profile and reduce unnecessary LDCT repeats in lung cancer screening. Targeting LDCT intervals on individual risk profile did not cause any detrimental effects on LC detection or mortality.
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.
