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Davide Tassinari



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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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      P1.01-14 - Immunotherapy (I) for Advanced, Pre-Treated, Non-Squamous NSCLC (APNS-NSCLC). Preliminary Data of a Pooled Analysis (ID 13469)

      16:45 - 18:00  |  Author(s): Davide Tassinari

      • Abstract
      • Slides

      Background

      Background. To assess the role of I for second line treatment of APNS-NSCLC.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Methods. A pooled analysis of the final data of the CA209057, the KEYNOTE-010 and the OAK trial was performed. Overall Survival (OS) was the primary end point of the trial. The outcomes of patients with PD-L1 expression of 1%-49% (PD-L1 1%-49%), PD-L1 expression <1% (PD-L1<1%) or mutated-EGFR (EGFR+) were analyzed comparing any checkpoint inhibitor with standard chemotherapy. An indirect comparison with network meta-analysis was performed between the different checkpoint inhibitors whenever a significant difference was observed in the pooled analysis. Direct and indirect comparisons were performed using a random effect model.

      4c3880bb027f159e801041b1021e88e8 Result

      Results. The outcome of 1720 patients was analyzed. 313 patients had been treated with Atezolizumab (A), 292 with Nivolumab (N), 270 with Pembrolizumab (P), and 845 with Docetaxel (D). The preliminary results were detailed in the table.

      Legend. CI95%: 95% Confidence Interval; *: Pooled Analysis; **: Network Meta-Analysis.

      OS Hazard Ratio

      CI95%

      A vs D (PD-L1 1%-49%)

      0.571

      0.423-0.771

      P<0.001

      N vs D (PD-L1 1%-49%)

      0.62

      0.467-0.882

      P=0.001

      P vs D (PD-L1 1%-49%)

      0.76

      0.604-0.956

      P=0.019

      I vs D (PD-L1 1%-49%)*

      0.66

      0.555-0.786

      P<0.001

      A vs N (PD-L1 1%-49%)**

      0.921

      0.609-1.392

      P=0.696

      A vs P (PD-L1 1%-49%)**

      0.751

      0.541-1.043

      P=0.087

      N vs P (PD-L1 1%-49%)**

      0.816

      0.597-1.116

      P=0.491

      N vs D (PD-L1<1%)

      0.9

      0.66-1.214

      P=0.491

      A vs D (PD-L1<1%)

      1.04

      0.619-1.747

      P=0.882

      I vs D (PD-L1<1%)*

      0.933

      0.72-1.21

      P=0.601

      P vs D (EGFR+)

      0.88

      0.453-1.71

      P=0.706

      N vs D (EGFR+)

      1.18

      0.693-2.004

      P=0.542

      I vs S (EGFR+)*

      1.052

      0.695-1.594

      P=0.81
      8eea62084ca7e541d918e823422bd82e Conclusion

      Conclusions. Our data seem to confirm the role of I for APNS-NSCLC with PD-L1 1%-49%. On the contrary, not-significant benefits in terms of OS seem to emerge for patients with PD-L1<1% or EGFR+ expression. Likewise, no significant differences seem to emerge from the indirect comparisons between A, N and P for patients with a PD-L1 1%-49% expression. Although all these data need to be analyzed with caution, as expression of indirect comparisons, waiting further conformations from clinical trials they can support clinicians for daily clinical practice.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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      P1.01-53 - Bone Metastases and Efficacy of Immunotherapy in Patients with Pretreated Advanced Non-Small-Cell Lung Cancer (NSCLC) (ID 11980)

      16:45 - 18:00  |  Author(s): Davide Tassinari

      • Abstract

      Background

      Approximately 40% of NSCLC patients develop bone metastases (BoM). Bone has active functions in regulating immune system. To date, no trial evaluated the role of BoM in modulating response to immunotherapy. Aim of the present study was to investigate whether presence of BoM impact on immunotherapy efficacy.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Two different cohorts of pretreated NSCLC patients (cohort A: Non-squamous; cohort B: Squamous) were evaluated for nivolumab efficacy in terms of objective response rate (ORR), progression free survival (PFS), and overall survival (OS) according to presence or absence of BoM. All patients received nivolumab at standard dose of 3 mg/kg every 2 weeks within the Italian Expanded Access Program.

      4c3880bb027f159e801041b1021e88e8 Result

      Cohort A accounted for 1588 patients with non-squamous NSCLC: 626 (39%) with (BoM+) and 962 (61%) without BoM (BoM-). Cohort B accounted for 370 patients with squamous histology: 102 BoM+ (32%) and 251 BoM- (68%). In Cohort A, BoM+ had a significantly lower ORR (12% versus 34%; p < 0.0001), shorter PFS (2.0 versus 4.0 months, p < 0.0001) and shorter OS (7.4 versus 15.3 months, p <0.0001). In cohort B, BoM+ had significantly lower ORR (15% versus 22%; p < 0.04), shorter PFS (2.7 versus 5.4 months, p <0.0001) and shorter OS (5.0 versus 10.9 months, p <0.0001). Presence of BoM negatively affected outcome irrespective of PS (OS cohort A: PS-0 BoM+ 12.0 versus 20.9 months in PS-0 BoM-, p<0.0001; OS cohort B: PS-0 BoM+ 5.8 versus 16.4 months in PS-0 BoM-, p<0.0001). Multivariate analysis confirmed that presence of BoM independently associated with higher risk of death with HR 1.64 and HR 1.78, for Cohort A and B, respectively.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Our results, the first assessing BoM in patients treated with immunotherapy, suggested that BoM predict lower efficacy of immunotherapy. BoM should be included as stratification factor in clinical trials.

      6f8b794f3246b0c1e1780bb4d4d5dc53