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Jinjiang Lian



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    MA05 - Update on Clinical Trials and Treatments (ID 123)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Mesothelioma
    • Presentations: 1
    • Now Available
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      MA05.10 - Pembrolizumab in the Treatment of Patients with Malignant Pleural Mesothelioma Following Progression After Initial Chemotherapy (Now Available) (ID 2788)

      13:30 - 15:00  |  Author(s): Jinjiang Lian

      • Abstract
      • Presentation
      • Slides

      Background

      Checkpoint inhibitor (CPI) therapies have demonstrated clinical benefit in patients (pts) with malignant pleural mesothelioma (MPM) and are now included in the NCCN guidelines as an acceptable treatment option. Herein, we report our initial experience treating pts with MPM in the palliative second line or greater setting.

      Method

      Between January 2016 and November 2018, 74 pts with biopsy proven MPM were treated with pembrolizumab every three weeks until confirmed disease progression or unacceptable toxicity. Progression-free survival (PFS) and OS were defined as the time from first pembrolizumab dose to recurrence and death, respectively, or to last contact. Response rates (RR) were measured by a dedicated thoracic radiologist using modified RECIST 1.1 criteria. Adverse events were routinely recorded/scored at each follow up visit. according to CTCAE 4.0 with level of attribution to pembrolizumab.

      Result

      Demographics of the 74 pt cohort are shown in table 1. Twently-nine (39%) of pts experienceda total of 39 grade 1-2 adverse events, possibly or definitely related to therapy (Table 2). There was one grade 4pneumonitis that resulted in new requirement for oxygen, which resolved with steroids; and one patient experienced leukoencephalopathy that resulted in death. The overall response rate (including only partial responses by modified RECIST 1.1) for the entire cohort was 26%. Median progression free survival and overall survival for the entire cohort were 2.8 months and 7.9 months, respectively.

      Table 2: Adverse Events

      CTCAE 4.0 Grade

      AE Description

      1-2

      3-4

      5

      hypothroid

      5

      arthralgias

      8

      colitis

      3

      diarrhea

      2

      lip lesion

      1

      pneumonitis

      2

      1

      SICCA syndrome

      1

      thrombocytopenia

      1

      dermatitis

      1

      hypopigmentation

      1

      nephritis

      1

      fatigue

      1

      abdominal pain

      1

      uveitis

      1

      transaminitis

      1

      elvated alk phos

      1

      leukoencephalopathy

      1

      pruritis

      3

      hypercalcemia

      3

      rash

      2

      Table 1: Demographics

      Age in Years

      median (range)

      Min

      73

      (52-92)

      Gender

      Patients (N=74)

      Female

      29

      39%

      Male

      55

      74%

      Histology

      Epithelial

      58

      78%

      Sarcomatoid

      6

      8%

      Biphasic

      10

      14%

      # of chemotherapy courses

      0

      3

      4%

      1

      42

      57%

      2

      22

      30%

      3-4

      7

      9%

      # of radiotherapy courses

      0

      42

      57%

      1

      30

      41%

      2-3

      6

      8%

      Surgical Resection

      Have EPD

      24

      32%

      Did not have EPD

      50

      68%

      PDL1

      Negative

      21

      28%

      Positive

      12

      16%

      Not Determined

      42

      57%

      Conclusion

      Pembrolizumab in the Tx of MPM was reasonably well tolerated in this large, single institution experience. RR, PFS and OS appear remarkably similar to recent published data from a registry study of off-label use of pembrolizumab in pts with MPM in Switzerland and Australia (include reference). Ongoing studies include analysis of PDL-1 and other potential immunotherapy response biomarkers.

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