Virtual Library
Start Your Search
E. Thunissen
Author of
-
+
OA13 - Immunotherapy in Malignant Pleural Mesothelioma: Current Status of Trials and New Approaches (ID 392)
- Event: WCLC 2016
- Type: Oral Session
- Track: Mesothelioma/Thymic Malignancies/Esophageal Cancer/Other Thoracic Malignancies
- Presentations: 1
-
+
OA13.01 - A Phase II Study of Nivolumab in Malignant Pleural Mesothelioma (NivoMes): With Translational Research (TR) Biopies (Abstract under Embargo until December 6, 7:00 CET) (ID 3881)
14:20 - 14:30 | Author(s): E. Thunissen
- Abstract
- Presentation
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:
Nivolumab in 2[nd] or later lines in recurrent MPM met the primary endpoint. The toxicity was mild and long lasting results were observed. A clear correlation between PD-L1 expression and response was obeserved.Outcome Age mean 66 yrs (51-81) M/F 28 / 6 Epithelial/mixed/non epithelial 28 / 4 / 2 PR/SD/PD 5 / 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 histology Epithelioid : 4/9/15 Mixed : 1/2/1 Non-epithelial : 0/1/1
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.
