Author of

• 18606

  +

  P3.03 - Poster Session with Presenters Present (ID 473)

  • Event: WCLC 2016
  • Type: Poster Presenters Present
  • Track: Mesothelioma/Thymic Malignancies/Esophageal Cancer/Other Thoracic Malignancies
  • Presentations: 1
  • Moderators:
  • Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)

  • 18634

    +

    P3.03-028 - Nivolumab for Advanced Malignant Pleural Mesothelioma outside of Clinical Trials: A Single Institution Experience (ID 5530)

    14:30 - 14:30  |  Author(s): D.J. Sugarbaker
    • Abstract

    Background:
    Malignant pleural mesothelioma (MPM) is a rare and aggressive malignancy with dismal prognosis. Cisplatin and pemetrexed combination has been established as standard 1st line chemotherapy for advanced MPM. There is no approved 2nd line therapy for MPM and early phase clinical trials have shown that programmed death-1 (PD-1) inhibitors are safe and effective. However, the majority of patients with advanced MPM are excluded from clinical trials due to their poor performance status (PS). We report a single institution’s experience with nivolumab, a humanized IgG4 monoclonal anti PD-1 antibody, in patients with poor PS outside of clinical trials.
    
    Methods:
    Patients with advanced MPM were treated at Baylor Clinic with nivolumab (3mg/kg every 2 weeks) through a Nivolumab Expanded Access Program (EAP). Response rate (RR) and disease control rate (DCR) were evaluated at 8 weeks (RECIST 1.1 criteria). All patients were assessed for treatment related adverse events (CTCAE 4.0). PD-L 1 expression on tissue samples were quantified by commercially available PD-L1 IHC 28-8 pharmDx assay.
    
    Results:
    Between 12/2015 and 6/2016, six patients were enrolled in a Nivolumab EAP. Five patients (83%) were males and the median age was 65 years (range 38-78). Four patients had received at least one line of platinum-based chemotherapy and two refused 1st line chemotherapy due to poor PS. Three patients had PS of 2 and three patients had PS of 3. Tumor histology included: epithelioid (n=3), biphasic (n=2), and sarcomatoid (n=1). Median treatment duration was 16 weeks (range 8-28 weeks). At 8 weeks, four patients had partial response (PR), one patient had stable disease (SD), and one patient had progressive disease(PD). Then RR was 67% and DCR was 83%. The four PR patients had PD-L1 expression of 0%, 35%, 40% and 70%, one SD patient had PD-L1 expression of 10%, and one PD patient had PD-L1 expression of 5%. All six patients had subjective clinical response with improved PS. Two patients had G2 fatigue, one patient had G1 depression. Five patients are still on treatment.
    
    Conclusion:
    Nivolumab is a safe and effective treatment option for advanced MPM patients with poor PS. Although tumor PD-L1 overexpression is related to treatment response, subjective clinical response is observed in advanced MPM patients regardless of tumor PD-L1 status. Our experience of nivolumab in advanced MPM patients with poor PS outside of clinical trials provides additional data to ongoing clinical trials.