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OA13.01 A Phase II Study of Nivolumab in Malignant Pleural Mesothelioma (NivoMes): with Translational Research (TR) Biopies

      Background

      No studies have reported any survival benefit in recurrent MPM. We examined the effect of nivolumab, in patients who presented with progressive disease and agreed to have biopsies taken before and during treatment.

      Methods

      In this single center, phase II study, patients received nivolumab (3mg/kg q2w) until progression or toxicity. The primary endpoint was an improvement of disease control rate at 12 weeks of 20 to >40% compared to historic control according to a Simon two-stage design. A total of 33 patients were planned with paired biopsies at week -1 and 6 according to treatment start. PD-L1 status and other biomarkers were analyzed.

      Results

      From 09-2015 until 06-2016, 38 patients were included with 33 having paired biopsies; 4 were not evaluable. There were no treatment related death and DCR at 12 weeks was 50%. Five patients had a confirmed PR; 12 had SD and 17 PD. Three patients showed pseudo-progression. Grade 3 toxicity occurred in 8 patients leading to discontinuation of the treatment in 4. The table shows the patients/tumor details. PD-L1 ≥1% was expressed in 9/32 evaluable patients with 2/9 having a confirmed PR at 12 weeks.

      Conclusion

      Tabled 1
      Outcome
      Agemean 66 yrs (51-81)
      M/F28 / 6
      Epithelial/mixed/non epithelial28 / 4 / 2
      PR/SD/PD5 / 12 / 17
      PD-L1 + (1-10; 10-25; 25-50; >50%)2 / 1 / 3 / 3
      Correlation PR/SD/PD according to PD-L1 expression<1% : 3/8/12 1 - 10% : 0/1/1 10-25% : 0/0/1 25-50% : 1/1/1 > 50% : 1/1/1
      Correlation PR/SD/PD with histologyEpithelioid : 4/9/15 Mixed : 1/2/1 Non-epithelial : 0/1/1

      Keywords

      Mesothelioma, Nivolumab, Immunotherapy, translational research